Pharmacopieal Forum Vol32No2

Table of Contents*
PHARMACOPEIAL FORUM VOL. 32 NO. 2 MAR.APR. 2006
STANDARDS DEVELOPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HOW TO USE PF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Section Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Committee Designations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Staff Directory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . POLICIES AND ANNOUNCEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PF Online Launches New My PF Product Enhancement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Notice of Correction to Helium, Nitrous Oxide, Nitrogen, and Nitrogen 97 Percent Monographs . . . . . . . . . . . . . . . General Chapters h1i and h905i PostponementsClarication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . USP Issues Notice of Retraction for Residual Solvents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Expert Committee Summaries Available on the USP Web Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . USP Seeks Submission of Proposals for Stability-Indicating Assay Procedures for Steroids . . . . . . . . . . . . . . . . . . . Pharmacopeial Education Courses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Visit the USP Web Site at hhttp://www.usp.orgi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . International Correspondence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . How to Submit Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . New Pharmacopeial Forum Public Review and Comment Period Deadlines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Publication Schedules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Call for High Priority Monographs for Drug Substances and Products and Excipients . . . . . . . . . . . . . . . . . . . . . . . SECOND INTERIM REVISION ANNOUNCEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NOTICE OF POSTPONEMENTMannitol Injection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NOTICE OF POSTPONEMENTSodium Chloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NOTICE OF POSTPONEMENTh621i Chromatography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MONOGRAPHS (USP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glucagon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diluted Isosorbide Mononitrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MONOGRAPHS (NF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sorbitol Sorbitan Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GENERAL CHAPTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h467i Organic Volatile Impurities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h467i Residual Solvents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h711i Dissolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GENERAL INFORMATION CHAPTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h1216i Tablet Friability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ERRATA LIST FOR USP 29NF 24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IN-PROCESS REVISION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MONOGRAPHS (USP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Allopurinol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amoxicillin Tablets (Proposal for 4th IRA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Atracurium Besylate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Azithromycin (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bisoctrizole [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bupropion Hydrochloride Extended-Release Tablets (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cefaclor Tablets [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cefadroxil for Oral Suspension (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cefepime Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cetirizine Hydrochloride [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cholestyramine Resin (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ciprooxacin (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ciprooxacin and Dexamethasone Otic Suspension [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . Ciprooxacin Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ciprooxacin Injection (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
233 237 238 240 241 245 246 246 246 246 246 247 247 248 248 248 248 249 249 259 263 264 265 266 266 268 270 270 270 270 277 286 289 289 291 295 302 302 305 305 306 309 312 314 315 316 317 320 320 321 325 326
* The USPNF (USP 30NF 25), the Supplement (Supp), or the Interim Revision Announcement (IRA) for which the revision proposal is targeted is shown in parentheses next to each proposed item.
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Pharmacopeial Forum Vol. 32(2) [Mar.Apr. 2006]

327 330 330 332 333 335 337 337 339 344 345 346 347 350 353 353 354 354 355 355 355 360 361 364 364 365 365 367 369 370 370 374 376 377 379 384 387 389 390 390 394 394 395 395 395 395 397 398 400 402 402 402 407 514 516 516 516 542 559 568 571
Dantrolene Sodium [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diazepam Extended-Release Capsules (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Doxepin Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ethotoin Tablets (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Famotidine Injection [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluconazole (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluoxetine Delayed-Release Capsules (Proposal for 4th IRA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluticasone Propionate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluticasone Propionate Nasal Spray [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fluvoxamine Maleate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indinavir Sulfate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lamivudine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Levooxacin [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lipid Injectable Emulsion [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Loperamide Hydrochloride Oral Solution (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Milk of Magnesia (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Methyldopa Oral Suspension (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Methylprednisolone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mitoxantrone Injection (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Morantel Tartrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nifedipine Extended-Release Tablets (Proposal for 4th IRA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Nimodipine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Paclitaxel (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pentobarbital Sodium Injection (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Potassium Perchlorate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prednisolone Sodium Phosphate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Promethazine Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Promethazine Hydrochloride Tablets (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pyridoxine Hydrochloride Injection (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quazepam Tablets (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ritonavir [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ropivacaine Hydrochloride Injection [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Spironolactone and Hydrochlorothiazide Tablets (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Triclosan (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valganciclovir Hydrochloride [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valganciclovir Tablets [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valproic Acid Injection [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Verapamil Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . EXCIPIENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Excipients, USP and NF Excipients, Listed by Category (1st Supp to NF 25) . . . . . . . . . . . . . . . . . . . . . . . . . . . DIETARY SUPPLEMENTSMONOGRAPHS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valerian (Proposal for 3rd IRA and 1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Powdered Valerian (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Valerian Tablets (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MONOGRAPHS (NF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alfadex (1st Supp to NF 25) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Coconut Oil [new] (1st Supp to NF 25) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Polyethylene Oxide (1st Supp to NF 25) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Polyvinyl Acetate [new] (1st Supp to NF 25) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tribasic Sodium Phosphate [new] (1st Supp to NF 25) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GENERAL TEST CHAPTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h1i Injections (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h11i USP Reference Standards (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h41i Weights and Balances (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h311i Alginates Assay (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GENERAL INFORMATION CHAPTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h1047i Biotechnology-Derived ArticlesTests (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h1052i Biotechnology-Derived ArticlesAmino Acid Analysis [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . h1053i Biotechnology-Derived ArticlesCapillary Electrophoresis [new] (1st Supp to USP 30) . . . . . . . . . . . . . . h1054i Biotechnology-Derived ArticlesIsoelectric Focusing [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . h1055i Biotechnology-Derived ArticlesPeptide Mapping [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . .
# 2006
The United States Pharmacopeial Convention, Inc.
All Rights Reserved.
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h1056i Biotechnology-Derived ArticlesPolyacrylamide Gel Electrophoresis [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h1057i Biotechnology-Derived ArticlesTotal Protein Assay [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . h1058i Analytical Instrument Qualication [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . h1070i Emergency Medical Services Vehicles and AmbulancesStorage of Preparations [new] (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REAGENTS, INDICATORS, AND SOLUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagent Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetaldehyde (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetanilide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetic Acid, Glacial (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetic Anhydride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetonitrile (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetophenone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p-Acetotoluidide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetylacetone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetyl Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acetylcholine Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acrylic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adipic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alprenolol Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alum (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alumina, Activated (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alumina, Anhydrous (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aluminon (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aluminum (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aluminum Oxide, Acid-Washed (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aluminum Potassium Sulfate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amaranth (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aminoacetic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-Aminoantipyrine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-Amino-6-chloro-1,3-benzenedisulfonamide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-Amino-2-chlorobenzoic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-Amino-5-chlorobenzophenone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-(2-Aminoethyl)piperazine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aminoguanidine Bicarbonate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-Aminohexamethyleneimine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-Amino-3-hydroxy-1-naphthalenesulfonic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . m-Aminophenol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p-Aminophenol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-Amino-1-propanol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonia Water, Stronger (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonia Water, 25 Percent (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Acetate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Bisulfate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Bromide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Carbonate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Citrate, Dibasic (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Fluoride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Hydroxide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Molybdate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Nitrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Oxalate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Persulfate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Phosphate, Dibasic (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Phosphate, Monobasic (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Reineckate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Sulfamate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Sulfate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ammonium Thiocyanate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
# 2006 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
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Ammonium Vanadate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amyl Acetate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amyl Alcohol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . tert-Amyl Alcohol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aniline (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aniline Blue (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anisole (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anthracene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anthrone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antimony Pentachloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antimony Trichloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Aprobarbital (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Arsenazo III Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Arsenic Trioxide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . L-Asparagine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barium Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barium Chloride, Anhydrous (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barium Hydroxide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Barium Nitrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzaldehyde (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzamidine Hydrochloride Hydrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . Benzanilide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzenesulfonamide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzenesulfonyl Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzhydrol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzoic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzophenone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p-Benzoquinone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-Benzoylbenzoic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzoyl Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzoylformic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzphetamine Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-Benzylaminopyridine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-Benzylimidazole (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Benzyltrimethylammonium Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . Bibenzyl (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Biphenyl (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,2-Bipyridine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4,4-Bis(4-amino-1-naphthylazo)-2,2-stilbenedisulfonic Acid (1st Supp to USP 30) . . . . . . Bis(2-ethylhexyl) Maleate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bis(2-ethylhexyl) Phthalate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bis(2-ethylhexyl) Sebacate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bis(2-ethylhexyl)phosphoric Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Bis(trimethylsilyl)acetamide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bis(trimethylsilyl)triuoroacetamide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Bis(trimethylsilyl)triuoroacetamide with Trimethylchlorosilane (1st Supp to USP 30) . . . . Blue Tetrazolium (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Boric Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Boron Triuoride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14% Boron TriuorideMethanol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Brilliant Green (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bromine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p-Bromoaniline (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-Bromosuccinimide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Brucine Sulfate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,3-Butanediol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,3-Butanedione (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Butyl Acetate, Normal (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Butyl Alcohol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Butyl Alcohol, Secondary (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Butyl Alcohol, Tertiary (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
229
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Butyl Benzoate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Butyl Ether (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . n-Butyl Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . tert-Butyl Methyl Ether (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . n-Butylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . tert-Butylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-tert-Butylphenol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Butyraldehyde (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Butyric Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Butyrolactone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cadmium Acetate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Cadmium Nitrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . Calcium Acetate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . Calcium Carbonate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Calcium Carbonate, Chelometric Standard (1st Supp to USP 30) . . . . . . . . Calcium Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Calcium Chloride, Anhydrous (1st Supp to USP 30) . . . . . . . . . . . . . . . . . Calcium Citrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calcium Hydroxide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Calcium Lactate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . Calcium Nitrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calcium Sulfate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . dl-10-Camphorsulfonic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . Capric Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Carbazole (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Carbon Disulde, CS (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Carbon Tetrachloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Carboxymethoxylamine Hemihydrochloride (1st Supp to USP 30) . . . . . . . Casein (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Catechol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cedar Oil (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ceric Sulfate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chenodeoxycholic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . Chloramine T (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chlorine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-Chloroadamantane (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . 3-Chloroaniline (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chlorobenzene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . m-Chlorobenzoic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . 4-Chlorobenzoic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . 4-Chlorobenzophenone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . Chloroform (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chlorogenic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . 1-Chloronaphthalene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . 2-Chloronicotinic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . 2-Chloro-4-nitroaniline, 99% (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . Chloroplatinic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . 5-Chlorosalicylic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . Chlorotrimethylsilane (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . Cholestane (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cholesteryl Benzoate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Choline Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . Chromium Trioxide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Chromotropic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Chromotropic Acid Disodium Salt (1st Supp to USP 30) . . . . . . . . . . . . . . Cinchonidine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cinchonine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Citric Acid, Anhydrous (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . Cobalt Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cobalt Nitrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cobaltous Acetate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Congo Red (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
# 2006 The United States Pharmacopeial Convention, Inc.
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Contents* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..

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Coomassie Brilliant Blue R-250 (1st Supp to USP 30) . . . . . . . . . . . . . . . Copper (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cortisone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . m-Cresol Purple (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Cupric Acetate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . Cupric Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Cupric Citrate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cupric Sulfate, Anhydrous (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . Cyanoacetic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Cyanogen Bromide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Cyclohexane (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cyclohexanol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . L-Cystine (1st Supp to USP 30) ............................... Decanol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Deuterium Oxide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Devardas Alloy (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . Dextran, High Molecular Weight (1st Supp to USP 30) . . . . . . . . . . . . . . Dextrin (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3,3-Diaminobenzidine Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . 2,3-Diaminonaphthalene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . Diatomaceous Earth, Flux-Calcined (1st Supp to USP 30) . . . . . . . . . . . . Diatomaceous Earth, Silanized (1st Supp to USP 30) . . . . . . . . . . . . . . . . Diatomaceous Silica, Calcined . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,6-Dibromoquinone-chlorimide (1st Supp to USP 30) . . . . . . . . . . . . . . . Dibutylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dibutyl Phthalate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . 2,5-Dichloroaniline (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . 2,6-Dichloroaniline (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . o-Dichlorobenzene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Dichlorouorescein (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Dichlorouoromethane (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . 2,4-Dichloro-1-naphthol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . 2,6-Dichlorophenol-indophenol Sodium (1st Supp to USP 30) . . . . . . . . . 2,6-Dichlorophenylacetic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . Dicyclohexylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Diethylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . N,N-Diethylaniline (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Diethylene Glycol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Diethylene Glycol Succinate Polyester (1st Supp to USP 30) . . . . . . . . . . Diethylenetriamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Di(2-ethylhexyl)phthalate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . Digitonin (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10,11-Dihydrocarbamazepine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . Dihydroquinidine Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . Dihydroquinine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,5-Dihydroxybenzoic Acid (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . Diiodouorescein (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Diisodecyl Phthalate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . Diisopropyl Ether (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Diisopropylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Diisopropylethylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . 2,5-Dimethoxybenzaldehyde (1st Supp to USP 30) . . . . . . . . . . . . . . . . . 1,2-Dimethoxyethane (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . (3,4-Dimethoxyphenyl)acetonitrile (1st Supp to USP 30) . . . . . . . . . . . . . Dimethyl Phthalate (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . Dimethyl Sulfone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . Dimethyl Sulfoxide, Spectrophotometric Grade (1st Supp to USP 30) . . . . N,N-Dimethylacetamide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . p-Dimethylaminoazobenzene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . p-Dimethylaminobenzaldehyde (1st Supp to USP 30) . . . . . . . . . . . . . . . 2,6-Dimethylaniline (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . N,N-Dimethylaniline (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . .
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657 657 657 657 657 658 658 658 658 659 659 659 659 659 659 660 660 660 660 661 661 662 663 678 681 683 685 687 688 695 699
3,4-Dimethylbenzophenone (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5,5-Dimethyl-1,3-cyclohexanedione (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dimethylformamide (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N,N-Dimethylformamide Diethyl Acetal (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N,N-Dimethyl-1-naphthylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N,N-Dimethyloctylamine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,6-Dimethylphenol (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N,N-Dimethyl-p-phenylenediamine Dihydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . m-Dinitrobenzene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3,5-Dinitrobenzoyl Chloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,4-Dinitrochlorobenzene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,4-Dinitrouorobenzene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . n-Heptane, Chromatographic (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Iminostilbene (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-Methylpyrrolidine (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Phenylhydrazine Hydrochloride (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Silica Gel, Octadecylsilanized Chromatographic (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Volumetric Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Potassium Hydroxide, Normal (1 N) (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REFERENCE TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Container Specications for Capsules and Tablets (1st Supp to USP 30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Description and Solubility (1st Supp to USP 30 and to NF 25) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PENDING PROPOSALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CANCELED PROPOSALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HARMONIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHARMACOPEIAL PREVIEWS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . STIMULI TO THE REVISION PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Instructions to Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Role of ContainerClosure Systems in Stability Testing for Climate Zone IV, H. Lockhart, S. Selke, and S. Yoon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NOMENCLATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
# 2006
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This updated directory reects assignment changes based on 20052010 Expert Committees. The general USP telephone number, (301) 881-0666, may still be used for general inquiries or when a particular Expert Committee is not identied. The fax number is (301) 816-8373.
STAFF Clydewyn M. Anthony, Ph.D., Scientist Shawn C. Becker, B.S.N., Director, Patient Safety Daniel K. Bempong, Ph.D., Scientist Lokesh Bhattacharyya, Ph.D., Director, Non-Complex Actives and Excipients Barbara A. Bowman, Manager, Administrative Services William E. Brown, Senior Scientist Evelyn Bryant, Manager, Editorial Services Damian A. Cairatti, Senior Scientic Associate E-MAIL cma@usp.org PHONE (301) 816-8139 ASSIGNMENT Monograph Development Cough, Cold, and Analgesics (MD-CCA) Safe Medication Use Pulmonary and Steroids (MD-PS)
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scb@usp.org dkb@usp.org lb@usp.org
(301) 816-8216 (301) 816-8143 (301) 816-8201
bab@usp.org
(301) 816-8278
USP Correspondence
web@usp.org
(301) 816-8380
Biopharmaceutics (BPC); Pharmaceutical Dosage Forms (PDF)
eb@usp.org dac@usp.org
(301) 816-8302 (301) 816-8307 USP Spanish Edition; Dietary SupplementsBioavailability (DS-BA); Dietary SupplementsGeneral Chapters (DS-GC) B&B Proteins and Polysaccharides (BB PP) USP Spanish Edition; General Chapters (GC)
Larry N. Callahan, Ph.D., Scientist Antonio Hernandez-Cardoso, Scientist, Latin American Specialist Todd L. Cecil, Ph.D., Vice President, Standards Development Roger Dabbah, Ph.D., Scientic Fellow Behnam Davani, Ph.D., Senior Scientist Ian F. DeVeau, Ph.D., Associate Director, Complex Actives
lnc@usp.org ahc@usp.org
(301) 816-8385 (301) 816-8308
tlc@usp.org
(301) 816-8234
rd@usp.org bd@usp.org
(301) 816-8336 (301) 816-8394 Monograph Development Antivirals and Antimicrobials (MD-AA) Biologics and Biotechnology Blood and Blood Products (BB BBP); Veterinary Drugs (VET); Veterinary Medicine Information (VMI) Reference Standards (RS)
ifd@usp.org
(301) 816-8178
Shawn F. Dressman, Ph.D., Director, Reference Standards Evaluation Lawrence Evans, Ph.D., Scientist
sfd@usp.org
(301) 816-8261
le@usp.org
(301) 816-8389
Dietary SupplementsGeneral Chapters (DS-GC); Dietary SupplementsNonBotanicals (DSN) Reference Standards (RS)
L. Valentin Feyns, Ph.D., Scientic Fellow
lvf@usp.org
(301) 816-8121
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HOW TO USE PF
STAFF DIRECTORY (continued)

STAFF Gabriel I. Giancaspro, Ph.D., Associate Director and Latin American Liaison E-MAIL gig@usp.org PHONE (301) 816-8343 ASSIGNMENT USP Spanish Edition, Dietary Supplements Botanicals (DSB); Dietary Supplements General Chapters (DS GC) Monograph Development Antibiotics (MD-ANT) Gastrointestinal, Renal, and Endocrine (MD-GRE) Packaging and Storage (P&S) Parenteral ProductsIndustrial (PPI) Monograph Development Cardiovascular (MD-CV) Compounding Pharmacy (CRX); Sterile Compounding (SCC)
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Brian D. Gilbert, Ph.D., Scientist Elena Gonikberg, Ph.D., Senior Scientist Desmond G. Hunt, Ph.D., Senior Scientic Associate James W. Kelly, Ph.D., Scientist Sujatha Ramakrishna, Ph.D., Scientist Christina H. Lee, Ph.D., Senior Scientic Associate Angela G. Long, Vice President, Volunteer and Organizational Affairs and Executive Secretariat Anju K. Malhotra, Manager, Scientic Administration Ronald G. Manning, Ph.D., Vice President, Monograph and Reference Standard Development Feiwen Mao, Senior Scientic Associate Margareth R. Marques, Ph.D., Senior Scientist and Latin American Liaison Marcia D. Mayeld, Manager, Monograph Development Kevin Moore, Ph.D., Scientist Tina S. Morris, Ph.D., Director, Complex Actives Alan W. Nichols, Ph.D., Director, Reference Standards Production Claudia C. Okeke, Ph.D., Associate Director, General Policies and Requirements Division Horacio Pappa, Ph.D., Scientist and Latin American Liaison W. Larry Paul, Ph.D., Scientic Fellow David A. Porter, Ph.D., Director, General Policies and Requirements
bg@usp.org eg@usp.org dgh@usp.org jwk@usp.org syk@usp.org chl@usp.org
(301) 816-8223 (301) 816-8251 (301) 816-8341 (301) 816-8167 (301) 816-8349 (301) 816-8335
agl@usp.org
(301) 816-8382
akm@usp.org rgm@usp.org
(301) 816-8346 (301) 816-8562
fm@usp.org
(301) 816-8320
Monograph Development Ophthalmology, Oncology, and Dermatology (MD-OOD) Biopharmaceutics (BPC); Pharmaceutical Dosage Forms (PDF); Chromatographic Reagents
mrm@usp.org
(301) 816-8106
mxm@usp.org ktm@usp.org tsm@usp.org awn@usp.org
(301) 816-8358 (301)816-8369 (301) 816-8397 (301) 816-8321 Harmonization; Monograph Improvement B&B Vaccines and Virology (BB-VV) USP Reference Standards
cco@usp.org
(301) 816-8243
Compounding Pharmacy Sterile Compounding (SCC) General Chapters (GC); Statistics (STAT) Nomenclature (NOM)
hp@usp.org
(301) 816-8319
wlp@usp.org dap@usp.org
(301) 816-8331 (301) 816-8225
# 2006
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STAFF DIRECTORY (continued)

STAFF Ravi Ravichandran, Ph.D., Senior Scientist Gary E. Ritchie, M.S., Scientic Fellow for PAT Karen A. Russo, Ph.D., Associate Director, Monograph Acquisition and Infrastructure Stefan P. Schuber, Ph.D., Director, Scientic Reports Maged H. M. Sharaf, Ph.D., Senior Scientist E-MAIL rr@usp.org PHONE (301) 816-8330 ASSIGNMENT Monograph Development Psychiatrics and Psychoactives (MD-PP) General Chapters (GC); Pharmaceutical Waters (PW); Statistics (STAT) How to Use PF Monograph Acquisition and Infrastructure
ger@usp.org
(301) 816-8353
kar@usp.org
(301) 816-8379
sps@usp.org mhs@usp.org
(301) 816-8551 (301) 816-8318 Dietary Supplements Botanicals (DSB); Dietary Supplements General Chapters (DS-GC) Excipient Monographs 1 (EM1); Excipient General Chapters (EGC); Harmonization
Catherine M. Sheehan, Scientist Eric B. Sheinin, Ph.D., USP Fellow Anita Y. Szajek, Ph.D., Senior Scientist Radhakrishna S. Tirumalai, Ph.D., Scientist
cxs@usp.org
(301) 816-8262
es@usp.org aey@usp.org rst@usp.org
(301) 816-8103 (301) 816-8325 (301) 816-8339 B&B Cell, Gene, and Tissue Therapies (BB CGT) General Toxicity and Medical Device Biocompatability (GTMDB); Microbiology and Sterility Assurance (MSA)
Beryl Voigt, Director, Executive Secretariat Hong Wang, Ph.D., Senior Scientic Associate Andrzej Wilk, Ph.D., Scientist
bev@usp.org hw@usp.org
(301) 816-8155 (301) 816-8351 Excipient Monographs 2 (EM2); Excipient General Chapters (EGC) Radiopharmaceuticals and Medical Imaging Agents (RMI); Radiopharmaceutical Information (RI) Aerosols (AER); General Chapters (GC)
aw@usp.org
(301) 816-8305
Kahkashan Zaidi, Ph.D., Scientist
kxz@usp.org
(301) 816-8269
# 2006
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POLICIES AND ANNOUNCEMENTS
PF ONLINE LAUNCHES NEW MY PF PRODUCT ENHANCEMENT. Beginning in March 2006, PF Online subscriptions will include My PF a value-added enhancement that allows users to save searches and bookmarks. This new option is FREE to PF Online subscribers and is provided in addition to standard Webbased features, including current issue search, advanced search, browse, print, and copy-paste. With My PF, PF Online users can perform the following functions:

For General Chapter h1i Injections, USP has postponed the text for Printing on Ferrules and Cap Overseals that was to become ofcial on October 1, 2005, as stated in USP 28NF 23. The reason for the postponement is that the Parenteral ProductsIndustrial, Nomenclature, and Safe Medication Use Expert Committees have approved a revision of this section that also appears in Pharmacopeial Forum 31(5), with an implementation date of February 1, 2009. For General Chapter h905i Uniformity of Dosage Units, USP has postponed the ofcial date from April 1, 2006 to January 1, 2007, to provide additional time for the Pharmacopeial Discussion Group to evaluate comments received concerning this revision. Further information about these postponements is available on USPs website (www.usp.org). If you have any questions, please contact Beryl Voigt, Director, Executive Secretariat (301-816-8155 or bev@usp.org). USP ISSUES NOTICE OF RETRACTION FOR RESIDUAL SOLVENTS. Please note the following retraction notice that has been included on page 14 of the USP 29NF 24. Residual Solvents h467i: meet the requirements. is hereby withdrawn from all monographs in the USP and the NF. This retraction is made to allow the USP Council of Experts further time to evaluate the most appropriate manner to implement the Residual Solvents test. The General Notices statement concerning the application of Residual Solvents to all monographs is unaffected by this retraction. This notice also serves as an additional request for comments on this issue from all users of the USP. Please forward your comments to: Todd Cecil, Ph.D. Vice President Department of Standards Development USP 12601 Twinbrook Parkway Rockville, MD 20852 Comments must be received by June 1, 2006 to ensure consideration. EXPERT COMMITTEE SUMMARIES AVAILABLE ON THE USP WEBSITE. Summaries of the rst meetings of the cycle for the 20052010 Standards Expert Committees are now posted and available at http:// www.usp.org/USPNF/meetingSummaries/.
Set up searches for specic USPNF monographs or general chapters to nd out if any recent changes have occurred in areas that impact their work. Run historical searches to track the progression of changes and chart comparisons. PF Online provides access to back issues, beginning with 2002. Bookmark monographs for easy access in the future. Bookmark frequently accessed information such as comment deadlines and liaison contact information. Find out if a new Reference Standard has been released by creating a search and run each time a new PF Online edition becomes available.
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For subscription information and additional details about PF Online, please visit http://www.usp.org/products/PF/ or contact USP Customer Service at 1-800-227-8772 or +1-301881-0666. NOTICE OF CORRECTION TO HELIUM, NITROUS OXIDE, NITROGEN, AND NITROGEN 97 PERCENT MONOGRAPHS. Because the revisions to these monographs, which were published in the First Supplement to USP 28NF 23 have been postponed indenitely, USP 29NF 24 by default should have shown the Identication and Assay tests as they originally appeared in the USP 28 NF 23 on pages 939, 1388, 3041, and 3041, respectively. Instead, these sections of the monographs were printed in error without the original text. See the USP website www.usp.org/USPNF/notices/ for the original text. Should you have any questions, please contact Kahkashan Zaidi, Ph.D., Senior Scientist, General Policies and Requirements Division (301-816-8269 or kxz@usp.org). G E N E R A L C H A P T E R S h1 i A N D h9 0 5 i P O S T P O N E M E N T S C L A R I F I C AT I O N . Tw o postponements that appeared in the Fifth IRA and Sixth IRA, respectively for h1i Injections and h905i Uniformity of Dosage Units do not appear as postponed in the USP 29NF 24. This is due to USPs publication schedule, which slates the Fifth IRA and Sixth IRA for the First Supplement to USP 29NF 24, rather than to the book. The First Supplement is scheduled to be published on February 15, 2006, and become ofcial on April 1, 2006. The complete publication schedule appears in this section of PF.
# 2006
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USP SEEKS SUBMISSION OF PROPOSALS FOR STABILITY-INDICATING ASSAY PROCEDURES FOR STEROIDS. The assay procedures for steroids in many USPNF monographs are not stability indicating. In an effort to update the monographs, the Monograph Development Pulmonary and Steroids Expert Committee is seeking submission of proposals for stability-indicating assay procedures for steroids, preferably HPLC- or GC-based, for inclusion in the following USPNF monographs to replace the current procedures that are not stability indicating. The submissions should include data and other information recommended in the USP Guideline for Submitting Requests for Revision to the USP NF at http://www.usp.org/pdf/EN/USPNF/revisionGuide.pdf. Each submission should include analytical validation data, data demonstrating that the procedure is stability indicating, and results of analysis from three commercial batches. Please submit proposals for steroid assay procedures for the following USPNF monographs to Daniel Bempong, Ph.D., or contact him for the details at 301-816-8143 or dkb@usp.org. Drug Substance: Clocortolone Pivalate Danazol Desoxycorticosterone Acetate Estriol Fludrocortisone Acetate Flumethasone Pivalate Hydrocortisone Sodium Phosphate Hydrocortisone Sodium Succinate Hydroxyprogesterone Caproate Levonorgestrel Meprednisone Mestranol Methylprednisolone Sodium Succinate Nandrolone Phenpropionate Norethindrone Norethindrone Acetate Norethynodrel Norgestrel Oxandrolone Oxymetholone Paramethasone Acetate Prednisolone Hemisuccinate Prednisolone Sodium Phosphate Testosterone Testosterone Enanthate Testosterone Propionate Dosage Form: Betamethasone Oral Solution Clocortolone Pivalate Cream Desoxycorticosterone Acetate Injection Desoxycorticosterone Acetate Pellets Dexamethasone Gel Dexamethasone Sodium Inhalation Aerosol Dexamethasone Tablets
Dexamethasone Topical Aerosol Estradiol Injectable Suspension Estradiol Tablets Estrone Injection Flumethasone Pivalate Cream Hydrocortisone Acetate Injectable Suspension Hydrocortisone Acetate Ophthalmic Ointment Hydrocortisone Acetate Ophthalmic Suspension Hydrocortisone Injectable Suspension Hydrocortisone Sodium Phosphate Injection Hydroxyprogesterone Caproate Injection Methylprednisolone Acetate Cream Methyltestosterone Capsules Methyltestosterone Tablets Nandrolone Phenpropionate Injection Norethindrone Acetate Tablets Norethindrone Acetate and Ethinyl Estradiol Tablets (assay for both steroids) Norethindrone Tablets Norgestrel Tablets Oxymetholone Tablets Paramethasone Acetate Tablets Penicillin G Procaine, Dihydrostreptomycin Sulfate, and Prednisolone Injectable Suspension (assay for Prednisolone) Neomycin Sulfate, Sulfacetamide Sodium, and Prednisolone Acetate Ophthalmic Ointment (assay for Prednisolone Acetate) Prednisolone Sodium Phosphate Injection Prednisolone Sodium Phosphate Ophthalmic Solution Neomycin Sulfate and Prednisolone Sodium Phosphate Ophthalmic Ointment (assay for Prednisolone Sodium Phosphate) Prednisolone Sodium Succinate for Injection Prednisolone Cream Progesterone Intrauterine Contraceptive System Testosterone Enanthate Injection Testosterone Injectable Suspension Testosterone Propionate Injection PHARMACOPEIAL EDUCATION COURSES. USPs Pharmacopeial Education courses offer specialized instruction for chemists, other scientists, and professionals in the pharmaceutical and allied industries. USP scientists who play a key role in establishing ofcial USP standards teach these courses and provide expert insights on the practical applications of ofcial test procedures and best practices in using the USPNF and other USP resources. The courses also give participants an opportunity to learn how to get involved in USPs standards-setting processes and the benets of participating in standards development. Courses offered in 2006 are listed below. For more information and to register, visit www.usp.org. To discuss how USP can bring courses to a location of your choice or design a custom course package for you, call 301-816-8237, or e-mail PharmacopeialEducation@usp.org.
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2006 Calendar of Pharmacopeial Education Courses
Date 18-Jan-06 24-25 Jan-06 14-Feb-06 15-Feb-06 23-Feb-06 29-Mar-06 19-Apr-06 20-Apr-06
Name of Course Effectively Using the USPNF Fundamentals of DissolutionLecture & Lab Effectively Using the USPNF Analytical Method Validation Effectively Using the USPNF Basic Statistics and their Practical Applications to the USPNF Effectively Using the USPNFSession I Effectively Using the USPNFSession II
Location California State UniversityFullerton, CA North Brunswick, NJ Basel, Switzerland Basel, Switzerland North Carolina State UniversityRaleigh, NC New Jersey, hosted by NJPQCA USP Headquarters, Rockville, MD USP Headquarters, Rockville, MD
Price $595 $1,500 $595 $595 $595 $595 $895 $895 ($1,695 both days)
VISIT THE USP WEB SITE AT hhttp://www.usp.orgi. Various resources related to Pharmacopeial standards are presented, including highlights from PF.
of the Brieng accompanying each item. To submit comments and data to a liaison, use the e-mail address and telephone numbers listed in the Staff Directory included in every PF. Please note that USPNF is being published in an annual edition with one main book and two Supplements a year. In addition, the schedule provided below will repeat every year so that users will know what to expect and become familiar with the deadlines. In the future, USP anticipates including the comment submission deadline in each brieng of every revision proposal when it is published for public review and comment. For general inquiries or in cases where a particular liaison is not identied, use the general USP telephone number 301881-0666 or FAX number 301-816-8373. NEW PHARMACOPEIAL FORUM PUBLIC REVIEW AND COMMENT PERIOD DEADLINES. The full years listing of comment period deadlines and the targeted ofcial publications appear below. In accordance with the Rules and Procedures of the 20052010 Council of Experts*, USP is implementing the 90-day comment period by providing a deadline for each issue of PF unless otherwise stated in the individual brieng. Note that PF 31(6) and PF 32(1) have a combined comment deadline (April 17, 2006) due to the omission of the comment deadline dates in PF 31(6). Individual comment deadlines begin with PF 32(2) [Mar.Apr. 2006].
INTERNATIONAL CORRESPONDENCE. Individuals who wish to correspond with the European and Japanese Pharmacopoeias concerning monographs in the Ofcial Inquiry and Consensus stages of international harmonization should address their comments to the coordinating pharmacopeia, with a copy to USP, for a given article. The addresses for the European and Japanese Pharmacopoeias are as follows: Technical Secretariat of the European Pharmacopoeia Commission B.P. 907 F 67029 Strasbourg Cedex 1 France NAKASHIMA Nobumasa Evaluation and Licensing Division Pharmaceutical and Medical Safety Bureau Ministry of Health, Labour and Welfare, Japan Tel. +81-3-3595-2431, Fax +81-3-3597-9535 E-mail: nakashima-nobumasa@mhlw.go.jp
HOW TO SUBMIT COMMENTS. The USP welcomes and encourages interested parties to submit comments and data regarding potential, proposed, or adopted (ofcial) standards. Submissions concerning a particular item that has appeared in an issue of PF should be submitted to the appropriate USP scientic staff liaison identied at the end
* Section 9.04(b) of the Rules and Procedures of the 20052010 Council of Experts
A period of at least ninety (90) days from the date of publication will be allowed for public review and comment. The time allowed for public comments shall be noted in the publication in the PF. For good cause shown, the Chairperson may alter the time specied.
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The listing of comment period deadlines and the targeted ofcial publications appear below.
Pharmacopeial Forum PF 31(6) PF 32(1) PF 32(2) PF 32(3) PF 32(4) PF 32(5) PF 32(6) PF 33(1) PF 33(2) Comment Deadline April 17, 2006 April 17, 2006 June 15, 2006 August 15, 2006 October 16, 2006 December 15, 2006 February 15, 2007 April 16, 2007 June 15, 2007 Targeted Ofcial Publication USP 30NF 25 USP 30NF 25 1st Supplement USP 30NF 25 2nd Supplement USP 31NF 26 USP 31NF 26 1st Supplement Publication Date November 2006 February 2007 June 2007 November 2007 February 2008 Ofcial Date January 2007 April 2007 August 2007 January 2008 April 2008
All ofcial revisions are published in the annual edition or Supplements to USPNF (twice yearly). Between these publications, ofcial revisions are published in PF in the Interim Revision Announcement; these revisions are also incorporated in the upcoming Supplement. The ofcial publication in which an IRA is incorporated will depend upon publication deadlines. The 5th IRA and the 6th IRA will not appear until Supplement 1. See table below. The electronic version of USPNF is updated as each Supplement becomes available and, therefore, contains all ofcial text up to and including the contents of the latest Supplement. The new table below outlines the publications and their release and ofcial dates, and the book or supplement which supersedes them.
Publication Schedules
Publication USP 29NF 24 1st Supplement 1st IRA [PF 32(1)] 2nd IRA [PF 32(2)] 3rd IRA [PF 32(3)] 2nd Supplement 4th IRA [PF 32(4)] 5th IRA [PF 32(5)] 6th IRA [PF 32(6)] USP 30NF 25 *Tentative Release Date Nov. 1, 2005 Feb. 1, 2006 Jan. 1, 2006 Mar. 1, 2006 May 1, 2006* June 1, 2006* July 1, 2006* Sept. 1, 2006* Nov. 1, 2006* Nov. 1, 2006* Ofcial Date Jan. 1, 2006 Apr. 1, 2006 Feb. 1, 2006 Apr. 1, 2006 June 1, 2006* Aug. 1, 2006* Aug. 1, 2006* Oct. 1, 2006* Dec. 1, 2006* Jan. 1, 2007* Superseded by 1st Supplement 2nd Supplement 2nd Supplement 2nd Supplement USP 30NF 25 USP 30NF 25 USP 30NF 25 1st Supplement USP 30NF25 1st Supplement USP 30NF25
CALL FOR HIGH PRIORITY MONOGRAPHS FOR DRUG SUBSTANCES AND PRODUCTS AND EXCIPIENTS. USP is seeking monographs for the following drug substances and drug products that are or soon will be off patent and thus are of the highest priority. USP also is seeking monographs for the excipients listed below. Monographs are marked received upon receipt of a monograph proposal. Received monographs are removed from this list upon publica-
tion in Pharmacopeial Forum. (This list has been updated as of December 15, 2005). This list is also available on the USP website at http://www.usp.org/USPNF/submitMonograph/ newMon.html. For further information, contact Karen Russo, Ph.D., kar@usp.org. Monograph sponsors should consult the USP Guideline for Submitting Requests for Revision to the USPNF at http://www.usp.org/pdf/EN/USPNF/revision Guide.pdf.
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Noncomplex Actives (Drug Substances) Acarbose Allopurinol Sodium Amlodipine Besylate (Received) Azelaic Acid Bepridil Hydrochloride Calcipotriene Candesartan Cilexetil Cefdinir Cetirizine Hydrochloride (Received) Chloroxine Dalfopristin Desirudin Docosanol Erythromycin Phosphate Esmolol Estradiol Benzoate Etoposide Phosphate Fluoromethane F 18 Gadobenate Dimeglumine Gallium Nitrate Granisetron Hydrocodone Polistirex Imiquimod Itraconazole Lawsone Levooxacin (Received) Lopinavir Miglitol Mivacurium Nalmefene Hydrochloride Nicardipine Hydrochloride Olopatadine Orlistat (Received) Pemoline Pirbuterol Acetate Quetiapine Fumarate Sertraline Hydrochloride Sterile Methotrexate Sodium Tacrolimus Tiludronate Disodium Trimipramine Maleate Zinc Tridosium Pentetate Alatrooxacin Mesylate Aminopromazine Fumarate Anagrelide Hydrochloride (Received) Balsalazide Disodium Bivalirudin Calcium Trisodium Pentetate Carmustine Cefditoren Pivoxil Cetrorelix Colfosceril Dantrolene Sodium (Received) Dexrazoxane Entacapone Erythromycin Thiocyanate Estazolam Ethanolamine Oleate Exemestane Foscarnet Sodium Galantamine Hydrobromide Ganirelix Halobetasol Propionate Ibandronate Sodium Irinotecan Lamotrigine (Received) Levetriacepam Levomethadyl Acetate Metipranolol Hydrochloride Mifepristone Moexipril Nateglinide Nilutamide Olsalazine Sodium Oxcarbazepine (Received) Pentamidine Isethionate Poractant Alpha Rose Bengal Sodium Phenylbutyrate Streptozocin Terbinane Hydrochloride Tiopronin Trovaoxacin Mesylate Alfuzosin Aminopterin Sodium Arsenic Trioxide Bentoquatam Cabergoline Calfactant Carvedilol Ceftibuten Cevimeline Cytarabine Liposome Dapirazole Hydrochloride Dioxacin Hydrochloride Epoprostenol Esomeprazole Magnesium Estramustine Phosphate Sodium Etomidate Felbamate Fosfomycin Tromethamine Gadopentetic Acid Glyceryl Aminobenzoate Haloperidol Decanoate (Received) Imipramine Pamoate Isosulfan Blue Latanoprost Levobetaxolol Lomustine Midazolam Hydrochloride Misoprostol (Received) Nalbuphine Hydrochloride Nedocromil Nisoldipine Orbioxacin Pantoprazole Sodium Piperonyl Butoxide Proguanil Salmeterol Xinafoate Simethicone Powder Sulfacytine Terconazole Tranexamic Acid Voriconazole
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Noncomplex Actives (Drug Products) Abacavir Sulfate, Lamivudine, and Zidovudine Tablets Acetaminophen, Clemastine Fumarate and Pseudoephedrine Hydrochloride Tablets Albuterol for Inhalation Alfuzosin Tablets Alprostadil Urethral Supository Aminopromazine Fumarate Tablets Amphotericin B Injection Atovaquone and Proguanil Hydrochloride Tablets Azatadine Maleate and Pseudoephedrine Sulfate Extended-Release Tablets Azithromycin Tablets Beclomethasone Dipropionate Inhalation Aerosol Benzocaine and Cetylpyridinium Chloride Lozenges Bepridil Tablets Bivalirudin Injection Bupivacaine and Lidocaine Hydrochlorides Injection Butalbital and Acetaminophen Tablets Calcipotriene Ointment Calcium Acetate Capsules Carbidopa and Levodopa ExtendedRelease Tablets Carmustine Implant Cefditoren Pivoxil Tablets Ceftibuten for Oral Suspension Cetrorelix Injection Choline and Magnesium Salicylates Oral Solution Ciclopirox Shampoo Ciclopirox Topical Gel Cilostazol Tablets (Received) Ciprooxacin Otic Solution Clonazepam Orally-Disintegrating Tablets Clotrimazole and Betamethasone Dipropionate Lotion Colfosceril and Tyloxapol Suspension Compound Undecylenic Acid Cream Cromolyn Sodium Metered-Dose Nasal Solution Cyclosporine Ointment Dantrolene Sodium Capsules (Received) Dantrolene Sodium for Injection (Received)
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Acarbose Tablets Acetazolamide Extended-Release Capsules Albuterol Inhalation Aerosol Allopurinol for Injection Aminopromazine Fumarate and Neomycin Sulfate Tablets Amlodipine and Benazepril Hydrochloride Capsules Anagrelide Hydrochloride Capsules Atovaquone Tablets Azelaic Acid Cream Baclofen Injection Beclomethasone Dipropionate MeteredDose Nasal Suspension Benzocaine and Menthol Lotion Bicalutamide Tablets Budesonide Metered-Dose Inhalation Aerosol Buprenorphine Hydrochloride Injection Calcipotriene Topical Solution Cabergoline Tablets Calcitriol Capsules Calfactant Intratracheal Suspension Carbidopa and Levodopa Tablets for Oral Suspension Carmustine for Injection Cefdinir Tablets Cetirizine Hydrochloride Oral Solution Cetirizine Hydrochloride Tablets Chloroxine Cream Choline and Magnesium Salicylates Tablets Ciclopirox Topical Solution Cimetidine Oral Solution Cladribine Injection Clemastine Fumarate Syrup Clorazepate Dipotassium Capsules Colestipol Hydrochloride Tablets Compound Undecylenic Acid Topical Powder Cyclosporine Modied Capsules Cyclosporine Topical Solution Dalfopristin and Quinupristin Injection Dantrolene Sodium Oral Suspension
Acetaminophen, Butalbital, Caffeine, and Codeine Phosphate Capsules Albuterol Extended-Release Tablets Alendronate Sodium Oral Solution Alprazolam Extended-Release Tablets Aminopromazine Fumarate Injection Aminopterin Sodium Tablets Arsenic Trioxide Injection Auranon Capsules Azithromycin for Injection Balsalazide Disodium Capsules Bentoquatam Topical Suspension Benzphetamine Hydrochloride Tablets Brompheniramine Maleate, Dextromethorphan Hydrobromide and Pseudoephedrine HCl Oral Solution Budesonide Inhalation Aerosol Butalbital and Acetaminophen Capsules Calcipotriene Cream Calcitriol Oral Solution Calcium Trisodium Pentetate Injection Carbidopa, Levidopa, and Entacapone Tablets Carvedilol Tablets Ceftibuten Capsules Ceftiofur Hydrochloride Oral Suspension Cevimeline Hydrochloride Capsules Chlorpromazine Hydrochloride ExtendedRelease Capsules Choline Salicylate Oral Solution Ciprooxacin Hydrochloride and Hydrocortisone Otic Suspension Citalopram Hydrobromide Oral Solution Citric Acid, Gluconolactone, and Magnesium Carbonate Irrigation Clobetasol Propionate Gel Clorazepate Dipotassium Extended-Release Tablets Conjugated Estrogens and Medroxyprogesterone Acetate Tablets Cyclosporine Modied Oral Solution Cysteamine Bitartrate Capsules Cytarabine Liposome Injection Dapiprazole for Ophthalmic Solution Desirudin for Injection Policies and Announcements
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Noncomplex Actives (Drug Products) (Continued) Desonide (Received) Dextroamphetamine Sulfate ExtendedRelease Capsules Diclofenac Sodium Ophthalmic Solution Difenoxin and Atropine Tablets Diltiazem Malate Extended-Release Tablets Divalproex Sodium Delayed-Release Capsules Doxacurium Chloride Injection Econazole Nitrate Cream Enalapril Maleate and Diltiazem Malate Extended-Release Tablets Ephedrine Sulfate and Guaifenesin Tablets Esmolol Hydrochloride Injection Estramustine Phosphate Sodium Capsules Etidronate Disodium Injection Concentrate Famotidine Orally Disintegrating Tablets Fentanyl Lozenges Flavoxate Hydrochloride Flunisolide Nasal Spray Fluocinolone Acetonide Shampoo Fluorometholone Ointment Fluticasone Propionate Pressurized Inhaler Gabapentin Oral Solution Gallium Nitrate Injection Ganciclovir Capsules Gatioxacin Tablets Glimepiride Tablets Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release Tablets Guanidine Hydrochloride Tablets Haloperidol Decanoate Injection Hydrochlorothiazide Oral Solution Concentrate Hydrocodone Bitartrate and Homatropine Methylbromide Syrup Hydrocodone Bitartrate and Aspirin Tablets Hydrocortisone Acetate Rectal Foam Aerosol Hydroumethiazide and Reserpine Tablets Ibandronate Sodium Tablets Imiquimod Topical Cream Irinotecan Hydrochloride Injection Itraconazole Injection Ketoconazole Shampoo Ketotifen Fumarate Lactic Acid Lotion Levetriacepam Tablets Leucovorin Calcium for Injection Lincomycin Hydrochloride and Spectinomycin Sulfate Soluble Powder
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Desonide Cream Dextromethorphan Polistirex ExtendedRelease Oral Suspension Didanosine Chewable Tablets (Received) Dioxacin Hydrochloride Tablets Dinoprostone Vaginal Suppositories Dorzolamide and Timolol Ophthalmic Solution Doxepin Hydrochloride Cream Edrophonium Chloride and Atropine Sulfate Injection Enalapril Maleate and Felodipine Extended-Release Tablets Epoprostenol for Injection Esomeprazole Magnesium Capsules Ethanolamine Oleate Injection Exemestane Tablets Felbamate Oral Suspension Fentanyl Transdermal System Flavoxate Hydrochloride Tablets Fluconazole Tablets Fluorescein Sodium Ophthalmic Solution Fluticasone Propionate Cream (Received) Foscarnet Sodium Injection Gabapentin Tablets Galantamine Hydrobromide Tablets Gentamicin Sulfate Oral Solution Glipizide Extended-Release Tablets Granisetron Tablets Guaifenesin and Salts of Dextromethorphan and Pseudoephedrine Oral Solution Halobetasol Propionate Ointment Haloperidol Lactate Injection Hydrocodone Bitartrate and Acetaminophen Oral Solution Hydrochlorothiazide Capsules Hydrocortisone Butyrate Lotion Hydroquinone Lotion Hydromorphone Hydrochloride Oral Solution Idarubicin Hydrochloride Injection Ipratropium Bromide Inhalation Aerosol Isosulfan Blue Injection Itraconazole Oral Solution Ketoprofen Capsules Ketotifen Fumarate Ophthalmic Solution Lamivudine Tablets Levobetaxolol Ophthalmic Suspension Levomethadyl Acetate Hydrochloride Oral Concentrate Liothyronine Injection
Dexrazoxane for Injection Diazepam Injectable Diethylpropion Hydrochloride ExtendedRelease Tablets Dihydroergotamine Mesylate Metered Spray Diphenhydramine Hydrochloride and Acetaminophen Tablets Dorzolamide Ophthalmic Solution Doxycycline Oral Gel Enalaprilat Injection Entacapone Tablets Epoprostenol Injection Estazolam Tablets Etomidate Injection Famotidine Injection (Received) Felbamate Tablets Ferrous Fumarate and Docusate Sodium Extended-Release Capsules Fluconazole Injection Flunisolide Inhalation Aerosol Fluticasone Propionate Inhalation Powder Fluticasone Propionate Ointment (Received) Fosfomycin for Oral Solution Gadobenate Dimeglumine Injection Ganirelix Acetate Injection Gatioxacin Injection Gentamicin Sulfate Soluble Powder Granisetron Injection Guanidine Hydrochloride Halobetasol Propionate Cream Haloperidol Lactate Oral Concentrate Hydralazine Hydrochloride and Hydrochlorothiazide Capsules Hydrocodone Bitartrate and Guaifenesin Oral Solution Hydrocodone Bitartrate and Homatropine Methylbromide Tablets Hydrocortisone Acetate Dental Paste Ibuprofen Capsules Imipramine Pamoate Capsules Ipratropium Bromide Inhalation Solution Isradipine Extended-Release Tablets Ketoconazole Cream Ketoprofen Extended-Release Capsules Ketoprofen Tablets Latanoprost Ophthalmic Solution Levocabastine Ophthalmic Suspension Levooxacin Solution Lisinopril and Hydrochlorothiazide Tablets
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Noncomplex Actives (Drug Products) (Continued) Lomustine Capsules Lopinavir and Ritonavir Solution Losartan Potassium Tablets Mesoridazine Besylate Concentrate Methadone Hydrochloride Oral Concentrate Methyclothiazide and Deserpidine Tablets Metronidazole Cream Methylphenidate Hydochloride Chewable Tablets Metronidazole Hydrochloride for Injection Miglitol Tablets Misoprostol Tablets (Received) Moexipril Hydrochloride and Hydrochlorothiazide Tablets Morphine Sulfate for Injection Concentrate Morphine Sulfate Tablets Mycophenolate Mofetil Capsules Naphazoline Hydrochloride and Pheniramine Maleate Ophthalmic Solution Nateglinide Tablets Nevirapine Oral Suspension (Received) Nilutamide Tablets Nitroglycerin Solution In Acrylic Adhesive Ooxacin In Dextrose Injection Olsalazine Sodium Capsules Orbioxacin Tablets Orphenadrine Citrate Extended Release Tablets Oxiconazole Cream Pantoprazole Sodium for Injection Pemirolast Potassium Ophthalmic Solution Pentaerythritol Tetranitrate ExtendedRelease Capsules Pentamidine Isethionate for Injection Phendimetrazine Tartrate ExtendedRelease Capsules Phenylephrine Hydrochloride and Chlorpheniramine Maleate Extended-Release Capsules Phosphate Oral Solution Pilocarpine Hydrochloride Tablets Povacrylate Solution Povacrylate-Iodine Topical Solution Povidone-Iodine Topical Aerosol Foam Prazosin Hydrochloride and Polythiazide Capsules Lopinavir Capsules Loratadine and Pseudoephedrine Sulfate Extended-Release Tablets (Received) Mesalamine Suppositories Meoquine Hydrochloride Tablets Melphalan for Injection Methocarbamol and Aspirin Tablets Metronidazole Lotion Metronidazole Capsules Miconazole Nitrate Topical Aerosol Milrinone Injection Mivacurium in Dextrose Injection Moexipril Hydrochloride Tablets Morphine Sulfate Oral Solution Mycophenolate Mofetil Tablets Nalbuphine Hydrochloride Injection Naphazoline Hydrochloride and Pheniramine Maleate Ophthalmic Solution Nedocromil Sodium Inhalation Aerosol Nevirapine Tablets (Received) Nimodipine Capsules Nizatidine Tablets Ooxacin Tablet (Received) Ondansetron Oral Solution Orlistat Capsules (Received) Oxcarbazepine Suspension Pancuronium Bromide Injection (Received) Paroxetine Hydrochloride ExtendedRelease Tablets Pemoline Tablets Pentaerythritol Tetranitrate ExtendedRelease Tablets Pentazocine Hydrochloride and Acetaminophen Tablets Phenobarbital Capsules Phenylephrine Hydrochloride, Chlor pheniramine Maleate, and Acetaminophen Extended-Release Tablets Pilocarpine Hydrochloride Ophthalmic Gel Piperonyl Butoxide and Pyrethrins Aerosol Foam Poractant Alpha Supension Povidone-Iodine Gauze Povidone-Iodine Vaginal Suppositories Prednisolone Sodium Phosphate Oral Solution Lopinavir Solution Loratadine Orally-Disintegrating Tablets Methacholine Chloride for Inhalation Solution Methoxsalen Softgels Metaraminol Bitartrate Injection Metipranolol Ophthalmic Solution Metronidazole Extended-Release Tablets Midazolam Hydrochloride Injection Mifepristone Tablets Misoprostol Dispersion (Received) Mivacurium Injection Molindone Hydrochloride Oral Solution Morphine Sulfate Oral Solution Concentrate Mycophenolate Mofetil Oral Solution Naproxen Extended-Release Tablets Nalmefene Hydrochloride Injection Neomycin Sulfate Oral Powder Nicardipine Hydrochloride Capsules Nisoldipine Extended-Release Tablets Ooxacin Injection Olopatadine Ophthalmic Solution Ondansetron Tablets Orphenadrine Citrate, Aspirin, and Caffeine Tablets Oxcarbazepine Tablets Pantoprazole Sodium Tablets Paroxetine Oral Suspension Penicillin G Potassium Tablets for Oral Solution Pentamidine Isethionate for Inhalation Permethrin Cream (Received) Phentermine Resin Complex Phentermine Resin Complex Capsules Pilocarpine Hydrochloride Ophthalmic Ointment Pirbuterol Acetate Inhalation Aerosol Pormer Sodium for Injection Povidone-Iodine Swabsticks Pramipexole Dihydrochloride Tablets Prochlorperazine Maleate Extended-Release Capsules Policies and Announcements
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Noncomplex Actives (Drug Products) (Continued) Progesterone Capsules Promethazine and Phenylephrine Hydrochlorides and Codeine Phosphate Syrup Pseudoephedrine Hydrochloride and Brompheniramine Maleate ExtendedRelease Tablets Pseudoephedrine Hydrochloride, Guaifenesin, and Codeine Phosphate Oral Solution Pseudoephedrine Sulfate, Dexbrompheniramine Maleate, and Acetaminophen Extended-Release Tablets Ranitidine Capsules Rimantadine Hydrochloride Oral Solution Risperidone Tablets Rocuronium Bromide Injection Rosiglitazone Maleate Tablets Salicylic Acid and Sulfur Shampoo Salmeterol Inhalation Aerosol Selegiline Hydrochloride Capsules Sibutramine Hydrochloride Capsules Sodium Chlorophyllin Copper Complex Tablets Sodium Phenylbutyrate Tablets Sodium Salicylate and Sulfur Shampoo Sucralfate Oral Suspension Sulfacetamide Sodium and Fluorometholone Ophthalmic Suspension Sulfasalazine Oral Suspension Sumatriptan Injection Tacrolimus Injection Tenofovir Disoproxil Fumarate Tablets Terbinane Topical Solution Testosterone Transdermal System Tioconazole Vaginal Ointment Topiramate Capsules Torsemide Tablets Tranexamic Acid Injection Tretinoin Capsules Triuridine Ophthalmic Solution Triprolidine and Pseudoephedrine Hydrochlorides and Codeine Phosphate Syrup Trolamine Salicylate Topical Emulsion Undecylenic Acid Topical Foam Aerosol Vecuronium Bromide for Injection Verapamil Hydrochloride Capsules Voriconazole Oral Suspension Yttrium Y-90 Glass Microspheres Zidovudine and Lamivudine Tablets Zinc Tridosium Pentetate Injection Promethazine Hydrochloride and Codeine Phosphate Oral Solution Promethazine and Phenylephrine Hydrochlorides Syrup Pseudoephedrine Hydrochloride and Naproxen Sodium Extended-Release Tablets Pseudoephedrine Sulfate and Dexbrompheniramine Maleate Extended-Release Tablets Pyrilamine Maleate Injection Rauwola Serpentina and Endroumethiazide Tablets Risperidone Oral Solution Rivastigmine Tartrate Capsules Ropinirole Hydrochloride Tablets Salicylic Acid and Sulfur Cleansing Lotion Salicylic Acid Cream Salmeterol Xinafoate Inhalation Powder Serpacwa Topical Cream Sodium Bicarbonate and Sodium Citrate for Oral Solution Sodium Iodide Injection Sodium Phosphates for Oral Suspension Sterile Talc Aerosol Sulconazole Nitrate Cream Sulfacytine Tablets Sumatriptan Tablets Tacrolimus Capsules Tamsulosin Hydrochloride Capsules Terbinane Hydrochloride Cream Terconazole Vaginal Cream Tetracycline Hydrochloride Periodontal Fiber Tiopronin Tablets Topiramate Tablets Trandolapril and Verapamil Hydrochloride Extended-Release Tablets Tranylcypromine Sulfate Tretinoin Microsphere Gel Trimetrexate for Injection Trolamine Salicylate Cream Trovaoxacin Injection Unoprostone Isopropyl Ophthalmic Solution Venlafaxine Extended-Release Capsules Verapamil Hydrochloride ExtendedRelease Capsules Voriconazole Tablets Yttrium Y-90 Microspheres Injection Zinc Acetate Capsules Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup Propafenone Hydrochloride Tablets Pseudoephedrine Hydrochloride, Chlorpheniramine Maleate, and Codeine Phosphate Oral Solution Pseudoephedrine Sulfate and Dexbrompheniramine Maleate Oral Solution Quinidine Sulfate Injection Ramipril Capsules Reserpine and Polythiazide Tablets Risperidone Orally Disintegrating Tablets Rivastigmine Tartrate Oral Solution Rose Bengal Ophthalmic Solution Salicylic Acid and Sulfur Lotion Salicylic Acid Ointment Scopolamine Transdermal System Sertraline Hydrochloride Oral Solution Sodium Bicarbonate, Sodium Citrate, and Sodium Tartrate for Oral Suspension Sodium Phenylbutyrate Oral Powder Sodium Phosphates Tablets Streptozocin for Injection Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution Sulfanilamide Vaginal Cream Sulisobenzone Lotion Tacrolimus Ointment Technetium Tc 99M Teboroxime Injection Terbinane Tablets Terconazole Vaginal Suppositories Theophylline Extended-Release Tablets Tolnaftate Topical Aerosol Solution Torsemide Injection Trandolapril Tablets Tranylcypromine Sulfate Tablets Triamcinolone Acetonide Metered-Dose Nasal Suspension Trimipramine Maleate Capsules Trolamine Salicylate Gel Trovaoxacin Mesylate for Injection Urea Cream Venlafaxine Tablets Voriconazole Injection Yttrium Y-90 Chloride Solution Ziprasidone Hydrochloride Capsules Zoledronic Acid for Injection
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Excipients
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Acetone Sodium Bisulte Aconitic Acid (Achilleic Acid) Aliphatic Polyesters Aluminum Lactate Aluminum Potassium Sulfate Aluminum Stearate Ammonium Calcium Alginate L-Asparagine Benzododecinium Bromide Brominated Vegetable Oil Butylene Glycol Calcium Alginate Calcium Chloride Solution Calcium Phospahte Dibasic, Monohydrate Calcium Pyrophosphate Calcium Sulfate Dihydrate Calteridol Calcium Caprylic/Capric Diglyceril Succinate Carboxymethylamylopectin Sodium Cetostearyl Isononanoate Chlorodiuoroethane Coconut Oil Hydrogenated (Received) Crystal Gum L-Cysteine Monohydrochloride Decanoic Acid Desoxycholic Acid Diacetyl Tartaric Acid Esters Of Mono- and Diglycerides Diethylene Glycol Monopalmitostearate Diglycol Stearate Diisopropylbenzothiazyl-2-Sulfenamide Dimyristoyl Lecithin Dipropylene Glycol Disodium Inosinate Erythorbic Acid Ethoxyquin Ethyl Maltol Ethylurea Ferric Oxide, Brown Ferrous Citrate Fluorochlorohydrocarbons Gamma-Cyclodextrin L-Glutamic Acid Glycerol Ester of Gum Rosin (Ester Gum) Glyceryl Ricinoleate Glycofurol Heptylparaben Hexanetriol(-1,2,6-) Hydroxyethylmethylcellulose Indigotine Iron Subcarbonate Isopropyl Isostearate Isostearyl Alcohol Lactylated Fatty Acid Esters of Glycerol and Propylene Glycol Lanolin Alcohols, Acetylated Lauramine Oxide
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Acetylated Monoglycerides Acrylic Acid-Octyl Acrylate Copolymer Aluminum Ammonium Sulfate Aluminum Oxide Aluminum Silicate Allantoin-Sodium Pyrrolidone Carboxylate Ammonium Phosphate Batylalcohol Monostearate Benzyl Chloride Butadiene-Styrene Rubber Butylphthalyl Butylglycolate Calcium Alginate and Ammonium Alginate Calcium Glycerophosphate (Received) Calcium Phosphate Monobasic Calcium Sorbate Calcium Sulfate, Anhydrous Canola Oil Carbon Carboxymethylcellulose Potassium Cholic Acid Cocamide Diethanolamine Cocoyl Caprylocaprate Cutina Dammar Gum Decyl Oleate Dextrin Palmitate Dicetyl Phosphate Diethyl Sebacate Diisobutyl Adipate Dilauryl Thiodipropionate Dimyristoyl Phosphatidylglycerol Disodium Edisylate Disodium Monooleamide Sulfasuccinate Erythrosine Ethyl Hexanediol Ethylene Dichloride Ferric Ammonium Citrate Ferric Phosphate Ferrous Glycinate Formic Acid Gentistic Acid Glutamic Acid Hydrochloride Glyceryl Laurate Glyceryl Tristearate Glycol Stearate Hexadecyl Isostearate Hydrocarbon Gel Hydroxylated Lecithin Inositol Isobutylated-Isoprene Copolymer Isopropyl Stearate Lactobionic Acid Lactylic Esters of Fatty Acids Lanolin (Wool Fat), Hydrogenated Lauric Acid
N-Acetyl-L- Methionine Albumin Colloidal Aluminum Hydroxide Aluminum Ammonium Sulfate Aluminum Sodium Sulfate Ammonium Bicarbonate L-Ascorbyl Stearate Beeswax, Synthetic Benzyl Nicotinate Beta Naphthol Butylated Hydromethylphenol Calcium Acid Pyrophosphate Calcium Bromide Calcium Phosphate Dibasic, Anhydrous Calcium Propionate Calcium Stearoyl Lactylate Caldiamide Sodium Capric Acid Carboxymethyl Starch Cinnamaldehyde Cocamide Oxide Coconut Oil Copper Sulfate Cystine Dehydroacetic Acid Dextrins Modied Dichlorouoromethane Diuoroethane Diisopropyl Adipate Dimethyl Dicarbonate Dioctyl Sodium Sulfosuccinate Disodium Guanylate Docusate Sodium/Sodium Benzoate Ethoxylated Mono- and Diglycerides Ethyl Linoleate Ethylene Glycol Monopalmitostearate Ferric Citrate Ferric Pyrophosphate Ferrous Lactate Furcelleran Geraniol Gluten Glyceryl Palmitate Glycine Hydrochloride Heptauoropropane Hexane Hydrogenated Starch Hydrolysate Hydroxypropyl Beta Cyclodextrin Iron Carbonyl Isooctylacrylate Isostearic Acid Lactose Ferrin, Bovine Lanolin Anhydrous Lanolin Hydrous Lauric Diethanolamide
256
Excipients (Continued) Lauric Myristic Diethanolamide L-Leucine Macrogol Oleate Macrogolglycerol Cocoates Magnesium Aspartate Magnesium Phosphate Tribasic Maltol Isobutyrate Manganese Citrate D-Mannose Medronic Acid Methyl Hydroxyethyl Cellulose Microcrystalline Cellulose, Silicied (Received) Monopotassium Glutamate Monohydrate Myristyl Gamma-Picolinium Chloride Naphtha Octanoic Acid Palm Oil Pentetate Pentasodium Phenylmercuric Nitrate Polyacrylate Dispersion 30 Percent (Received) Polyglycerol Esters of Fatty Acids Polyoxyl Stearate (USP has 40) Polyvinylacetal Polypropylene Stearyl Ether Potassium Acid Tartrate Potassium Dichloroisocyanurate Potasssium Iodate Potassium Phosphate Tribasic Potassium Stearate Potassium Tripolyphosphate Propyl Propionate Rapeseed Oil, Superglycerinated Silicone Sodium Aluminum Phosphate Acidic Sodium Bisulfate Sodium Carboxymethyl Betaglucan Sodium Citrate, Dibasic Sodium Diacetate Sodium Ferrocyanide Sodium Lauroyl Sarcosinate Sodium Magnesium Silicate Sodium Metasilicate Sodium Potassium Tripolyphosphate Sodium Sesquicarbonate Sodium Thiomalate Sodium Tripolyphosphate Stannous Tartrate Stearalkonium Chloride Succinylated Monoglycerides Sucrose Stearate Sulfobutyl Ether Beta Cyclodextran Tallow Oil Thyme Oil
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Lavender Oil Linoleic Acid Macrogol Sorbitan Tristearate Macrogolglycerol Triisostearate Magnesium Aspartame Dihydrate Magnesium Tartrate Malt Syrup Manganese Glycerophosphate Medical Antifoam Emulsion C Methyl Chloride Methylisothiazolinone Mineral Spirits Monosodium Citrate Myristyl Lactate Non-Pareil Seeds Oxystearin Pentasodium Triphosphate Phenprobamate Pine Oil Polydextrose Polyglycerol Polyricinoleic Acid Polypropylene Oleate Polyvinylacetal Diethylanoacetate Polyvinylpyrrolidone Ethylcellulose Potassium Bromate Potassium Gibberellate Potassium Nitrite Potassium Polymetaphosphate Potassium Sulfate Propylene Glycol Diacetate Puried Polyoxyl 35 Castor Oil (Received) Rice Bran Wax Sodium Acid Pyrophosphate Sodium Aluminum Phosphate Basic Sodium Bisulte Sodium Caseinate Sodium Citrate, Monobasic Sodium Erythorbate Sodium Hypophosphite Sodium Lauryl Sulfoacetate Sodium Malate Sodium Methylate Sodium Pyrophosphate Sodium Sesquinoleate Sodium Trimetaphosphate Soy Polysaccharides Starch, Pregelatinized Corn Stearyl Citrate Sucrose Acetate Isobutyrate Sucrose Syrup Tallow Tetrauoroethane Tribehenin
Lecithin, Hydroxylated Macrogol Lauryl Ether Macrogol Stearyl Ether Magnesium Aluminum Silicate Hydrate Magnesium Phosphate, Diabasic, Trihydrate Maltitol Syrup Manganese Chloride Manganese Hypophosphite Medronate Disodium Methylchloroisothiazolinone N-Methylpyrrolidone (Received) Monoisostearyl Glyceryl Ester Mullein Leaf N,N-Bis(2-Hydroxyethyl) Stearamide Nutmeg Oil Palm Kernel Oil Pentetate Calcium Trisodium Phenylmercuric Acetate Polacrilin Polydextrose Solution Polyoxyethylene Castor Oil (USP has 35) Polyvinyl Acetate (Received) Polyvinylpolypyrrolidone Polysorbate 65 Potassium Carbonate Solution Potassium Glycerophospate Potassium Phosphate Potassium Pyrophosphate Potassium Sulte Propylene Glycol Mono- and Diesters Rapeseed Oil, Hydrogenated Rosin Sodium Aluminosilicate Sodium Aspartate Sodium Carbonate Hydrate Sodium Chlorate Sodium Dehydroacetate Sodium Ferric Pyrophosphate Sodium Laureth Sulfate Sodium Magnesium Aluminosilicate Sodium Metaphosphate, Insoluble Sodium Polyphosphates Glassy Sodium Pyrrolidone Carboxylate Sodium Stearoyl Lactylate Sodium Trioleate Stannous Chloride Starch, Pregelatinized Tapioca Stearyl Monoglyceridyl Citrate Sucrose Fatty Acid Esters Sugar Fruit Fine Tallow Glycerides Thioglycerol Triceteareth-4 Phosphate
257
Excipients (Continued) Trichloroethylene Trolamine Lauryl Sulfate Wheat Gluten Trimyristin Vegetable Oil Wheat Germ Oil Trisidium Citrate Wheat Flour Whey
# 2006
STIMULI TO THE REVISION PROCESS
Stimuli articles do not necessarily reect the policies of the USPC or the USP Council of Experts
687
Instructions to Authors
Contributions in the form of original research reports, evaluations of new and existing compendial methods, and other commentaries and articles relevant to drug standards or to USPNF revision will be considered for publication in the Pharmacopeial Forum under the section Stimuli to the Revision Process. Manuscripts are received with the explicit understanding that they have not been published previously and that they are not simultaneously under consideration by any other publication. All manuscripts are subject to review by USP headquarters staff, Committee members, or qualied outside referees, and if accepted for publication will be subject to editing by USP staff. Accepted manuscripts become the property of the USP Convention (USPC) and may not be published elsewhere without written permission from the USPC. Authors are also responsible for obtaining permission for reprinting any illustrations that have been published elsewhere. AbstractInclude an abstract of not more than 250 words stating the purpose and the results or conclusions of the article. ReferencesConsult a current copy of the Pharmacopeial Forum and the ACS Style Guide for assistance with reference style. CopyrightCopyright transfer documents will be sent to authors after manuscripts have been accepted for publication. Contact PersonWhen submitting a manuscript, designate one author of the article as correspondent and include that authors full address, telephone number, fax number, and e-mail address. Submission InstructionsManuscripts must be submitted both as an electronic le and as a printed copy of the electronic le. Submit the text in Microsoft1 Word or another current word-processing application. The preferred format for graphics submitted electronically is tagged image le format (TIFF). Graphics that cannot be submitted electronically must be camera-ready, of easily reproducible quality and size, and clearly labeled. Photocopies are not acceptable. Manuscripts submitted for publication should be addressed to: Pharmacopeial Forum Executive Secretariat, USP 12601 Twinbrook Pkwy. Rockville, MD 20852
Stimuli to the Revision Process
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STIMULI TO THE REVISION PROCESS 688

Stimuli articles do not necessarily reect the policies of the USPC or the USP Council of Experts
The Role of ContainerClosure Systems in Stability Testing For Climate Zone IV*
H. Lockhart, Michigan State University; S. Selke, Michigan State University; S. Yoon, Eli Lilly and Company
Stimuli to the Revision Process
ABSTRACT The authors suggest that designation of long-term stability test conditions must include the effect of barrier packaging on the atmosphere inside the package. In December 2004, the Association of South East Asian Nations (ASEAN) proposed to the World Health Organization (WHO) that the standard for long-term stability testing for markets in Climate Zone IV be changed from 30 8C, 65% relative humidity (RH) to 30 8C, 75% RH. The argument for this proposal was based on the effect of absolute humidity on drug products. It did not take into account the effect of barrier packaging on control of the absolute humidity inside the package. The authors stipulate that selection of stability test conditions must include consideration of package permeation, storage temperature, and the permeation driving force, i.e., partial pressure for water vapor. The authors show that for challenge of the packaged drug product, relative humidities lower than 75% at 30 8C would adequately represent the ASEAN countries Climate Zone average condition of 27 8C, 79% RH. Laboratory testing is advised.
INTRODUCTION Some questions have been raised during international discussions of test conditions for stability testing for Climate Zone IV (15 ). The current ASEAN Climate Zone IV is 30 8C, 66% RH. At the Consultation to Discuss Stability Studies in a Global Environment on 1314 December 2004 at WHO Headquarters in Geneva, it was proposed by the ASEAN countries that stability test conditions for Climate Zone IV should be changed to 30 8C and 75% RH. This would result in a change to the WHO Guidelines for stability testing. The Recommendations Agreed To by the Meeting ( 1 ) recognized three options available to WHO. The options are the following: 1) revert to 30 8 C, 70% RH; 2) change to 30 8C, 75% RH; or 3) add a new Climate Zone IVb (30 8C, 75% RH), making the present 30 8C, 65% RH the stability test condition for Climate Zone IVa. Delegates were charged with the task of providing feedback and recommendations from their constituencies to WHO about the options. Two items in the discussions during the Consultation deserve comment. First, the presenters favoring 30 8C, 75% RH based their arguments on the assumption that absolute humidity is the governing atmospheric condition for permeation of moisture into a containerclosure system. This is not so. The atmospheric driving force for moisture permeation into a container is the pressure differential for water vapor between the inside and the outside of the containerclosure system. Second, two presenters (3,4) and one author (5) stated that glass bottles and high-density polyethylene (HDPE) bottles are impermeable to moisture when they have metal caps or high-density polyethylene caps. This, also, is not true.
This Stimuli article is intended to serve as feedback to WHO on the subject of the function of the containerclosure system during stability testing. It addresses the questions of impermeability and the forces that drive permeation. MOISTURE PERMEATION MECHANISM OF CONTAINERCLOSURE SYSTEMS Nearly all containerclosure systems are permeable to water vapor (moisture). Only a few are not. Among the moisturepermeable containerclosure systems commonly used in the pharmaceutical industry are the following: HDPE containers with any metal or plastic screw closures, low-density polyethylene (LDPE) containers with any metal or plastic closures, glass containers with any metal or plastic closure, polyvinyl chloride (PVC) blisters with lidding, PVC/polyvinylidene chloride (PVdC) blisters with lidding, and PVC/Aclar blisters with lidding. Examples of moisture-impermeable containerclosure systems include ame-sealed glass ampuls, and possibly aluminum (Al/Al) blisters. These Al/Al blisters usually test at or near zero permeation, but given a long enough time of exposure to test conditions, a low permeation rate may be found. Permeation into Al/Al blisters may happen through the seal or through pinholes in the aluminum foil. Bottle containerclosure systems have a container and a closure. The closure consists of two parts, the cap and the cap liner. The closures moisture seal is the cap liner, which consists of the facing, which is a barrier material, and a resilient backing material. The backing material serves to keep the facing (the barrier) in close contact with the top of the container nish (the threaded neck). Permeation into glass containers varies depending on the kind of material in the liner and the size (area) of the liner. The larger the area, the greater is the permeation. In Table 1, the 90-mL bottle with a 38-mm diameter cap size has a much larger area of liner facing than does the 30-mL bottle with only a 28-mm diameter cap size. The permeation for the metal cap with pulp/vinyl/wax liner is correspondingly higher for the 90mL bottle than it is for the 30-mL bottle.
Correspondence should be addressed to: Desmond Hunt, Ph.D., Senior Scientic Associate, Department of Standards Development, U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; tel. 301.816.8341; e-mail dgh@usp.org.
# 2006
696
NOMENCLATURE
USP Dictionary of USAN and International Drug Names 2005 USP DICTIONARY SUPPLEMENT 6
IMPORTANTSave this Supplement. This and all supplements appearing in PF are needed to keep the 2005 edition of the USP Dictionary (USPD) up-to-date. The cumulative contents of the supplements to the current (2005) edition will be included in the next complete edition of the Dictionary.
Revisions of United States Adopted Names (USAN)

The following are revisions of existing United States Adopted Names (USAN) and other names.
Fampronil Change the chemical information and structure to read: C16H6Cl3F3N6. 445.61. 2-{5-Chloro-1-[2,6-dichloro-4-(triuoromethyl)phenyl]-3-methyl-1H-pyrazol-4-yl}-1H-imidazole-4,5-dicarbonitrile. CAS-134183-95-2. INN.
Fenitrothion Change the chemical structure to read:
Nomenclature
Flunoxaprofen Change the chemical information and structure to read: C16H12FNO3. 285.27. (S)-(+)-2-(p-Fluorophenyl)-a-methyl-5-benzoxazoleacetic acid. CAS-66934-18-7. INN; MI. Fasoracetam Change the chemical structure to read:
Flupentixol Change the chemical information and structure to read: Fendiline Change the chemical information and structure to read: C23H25N. 315.45. N-(3,3-Diphenylpropyl)-a-methylbenzylamine. CAS-13042-18-7. INN; MI. C23H25F3N2OS. 434.52. (Z)-2-Trioromethyl-9-[3-[4-(2-hydroxyethyl)piperazin-1-yl]propylidene]thioxanthene. CAS-2709-56-0. INN; BAN; DFC; MI. [Name previously used: Flupenthixol.] N7009; LC 44.
Foscolic Acid Fenharmane Change the chemical information and structure to read: C18H18N2. 262.35. 1-Benzyl-2,3,4,9-tetrahydro-1H-pyrido[4,3-b]indole. CAS-3851-30-7. INN. Change the chemical formula and structure to read: C6H11O8P.
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NOMENCLATURE
697
Mitomycin Change the chemical structure to read:
Nomenclature
# 2006

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PHARMACOPEIAL FORUM VOL. 32 NO. 2 MAR.APR. 2006

Pharmacopeial Forum Vol. 32(2) [Mar.Apr. 2006]

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POLICIES AND ANNOUNCEMENTS

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Policies and Announcements

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POLICIES AND ANNOUNCEMENTS

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POLICIES AND ANNOUNCEMENTS

Pharmacopeial Forum Vol. 32(2) [Mar.Apr. 2006]

Pharmacopeial Forum Vol. 32(2) [Mar.Apr. 2006]

POLICIES AND ANNOUNCEMENTS

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POLICIES AND ANNOUNCEMENTS

Pharmacopeial Forum Vol. 32(2) [Mar.Apr. 2006]

Policies and Announcements

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Pharmacopeial Forum Vol. 32(2) [Mar.Apr. 2006]

POLICIES AND ANNOUNCEMENTS

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POLICIES AND ANNOUNCEMENTS