Vous êtes sur la page 1sur 3

Accessed from 10.6.1.

10 by Kalbe8 on Tue Dec 30 23:10:06 EST 2014

Second Supplement to USP 37NF 32


Isobutane: Colorless, flammable gas (boiling temperature is about 11). Vapor pressure at 21 is about
2950 mm of mercury (31 psig). NF category: Propellant.
Isobutyl Alcohol: Clear, colorless, mobile liquid. Soluble
in water. Miscible with alcohol, with ether, and with many
other organic solvents. NF category: Flavors and fragrance;
solvent.
Isoetharine Inhalation Solution: Colorless or slightly
yellow, slightly acid liquid, gradually turning dark on exposure to air and light.
Isoetharine Hydrochloride: White to off-white,
odorless, crystalline solid. Melts between 196 and 208,
with decomposition. Soluble in water; sparingly soluble in
alcohol; practically insoluble in ether.
Isoetharine Mesylate: White or practically white,
odorless crystals having a salty, bitter taste. Freely soluble in
water; soluble in alcohol; practically insoluble in acetone
and in ether.
Isoflurane: Clear, colorless, volatile liquid, having a
slight odor. Boils at about 49. Insoluble in water. Miscible
with common organic solvents and with fats and oils.
Delete the following:
Isoflurophate: Clear, colorless or faintly yellow liquid. Its
vapor is extremely irritating to the eye and mucous membranes. Is decomposed by moisture, with the formation of
hydrogen fluoride. Specific gravity is about 1.05. Soluble in
alcohol and in vegetable oils; sparingly soluble in water.
2S (USP37)

Isoleucine: White, practically odorless crystals, having a


slightly bitter taste. Soluble in water; slightly soluble in hot
alcohol; insoluble in ether.
Isometheptene Mucate: White, crystalline powder.
Freely soluble in water; soluble in alcohol; practically insoluble in chloroform and in ether.
Isoniazid: Colorless or white crystals or white, crystalline powder. Is odorless and is slowly affected by exposure
to air and light. Freely soluble in water; sparingly soluble in
alcohol; slightly soluble in chloroform; very slightly soluble
in ether.
Isoniazid Injection: Clear, colorless to faintly greenishyellow liquid. Gradually darkens on exposure to air and
light. Tends to crystallize at low temperatures.
Isopropamide Iodide: White to pale yellow, crystalline
powder, having a bitter taste. Freely soluble in chloroform
and in alcohol; sparingly soluble in water; very slightly soluble in benzene and in ether.
Isopropyl Alcohol: Transparent, colorless, mobile, volatile liquid, having a characteristic odor and a slightly bitter
taste. Is flammable. Miscible with water, with alcohol, with
ether, and with chloroform. NF category: Solvent.
Azeotropic Isopropyl Alcohol: Transparent, colorless,
mobile, volatile liquid, having a characteristic odor and a
slightly bitter taste. Is flammable. Miscible with water, with
alcohol, with ether, and with chloroform.
Isopropyl Myristate: Clear, practically colorless, oily liquid. Is practically odorless, and congeals at about 5. Freely
soluble in 90% alcohol; insoluble in water, in glycerin, and
in propylene glycol. Miscible with most organic solvents and
with fixed oils. NF category: Vehicle (oleaginous); emollient;
solvent.
Isopropyl Palmitate: Colorless, mobile liquid having a
very slight odor. Soluble in acetone, in castor oil, in chloroform, in cottonseed oil, in ethyl acetate, in alcohol, and in
mineral oil; insoluble in water, in glycerin, and in propylene
glycol. NF category: Vehicle (oleaginous); emollient; solvent.
Isoproterenol Inhalation Solution: Colorless or practically colorless, slightly acid liquid, gradually turning dark on
exposure to air and light.

Reference Tables / Description and Solubility 6993


Isoproterenol Hydrochloride: White to practically
white, odorless, crystalline powder, having a slightly bitter
taste. Gradually darkens on exposure to air and light. Its
solutions become pink to brownish pink on standing exposed to air, doing so almost immediately when rendered
alkaline. Its solution (1 in 100) has a pH of about 5. Freely
soluble in water; sparingly soluble in alcohol and less soluble
in dehydrated alcohol; insoluble in chloroform and in ether.
Isoproterenol Hydrochloride Injection: Colorless or
practically colorless liquid, gradually turning dark on exposure to air and light.
Isoproterenol Sulfate: White to practically white,
odorless, crystalline powder. It gradually darkens on exposure to air and light. Its solutions become pink to brownish
pink on standing exposed to air, doing so almost immediately when rendered alkaline. A solution (1 in 100) has a pH
of about 5. Freely soluble in water; very slightly soluble in
alcohol, in benzene, and in ether.
Isosorbide Concentrate: Colorless to slightly yellow liquid. Soluble in water and in alcohol.
Diluted Isosorbide Dinitrate: Ivory-white, odorless
powder. [NOTEUndiluted isosorbide dinitrate occurs as
white, crystalline rosettes.] Undiluted isosorbide dinitrate is
very soluble in acetone; freely soluble in chloroform; sparingly soluble in alcohol; very slightly soluble in water.
Isotretinoin: Yellow crystals. Soluble in chloroform;
sparingly soluble in alcohol, in isopropyl alcohol, and in polyethylene glycol 400; practically insoluble in water.
Isoxsuprine Hydrochloride: White, odorless, crystalline
powder, having a bitter taste. Melts at about 200, with
decomposition. Sparingly soluble in alcohol; slightly soluble
in water.
Isradipine: Yellow, fine crystalline powder.
Itraconazole: A white or almost white powder. Freely
soluble in methylene chloride; sparingly soluble in tetrahydrofuran; very slightly soluble in alcohol; practically insoluble
in water.
Ivermectin: White to yellowish-white, crystalline powder.
Slightly hygroscopic. Freely soluble in methanol and in
methylene chloride; soluble in acetone and in acetonitrile;
practically insoluble in hexane and in water.
Juniper Tar: Dark brown, clear, thick liquid, having a
tarry odor and a faintly aromatic, bitter taste. Sparingly soluble in solvent hexane; very slightly soluble in water. One
volume dissolves in 9 volumes of alcohol. Dissolves in 3
volumes of ether, leaving only a slight, flocculent residue.
Miscible with amyl alcohol, with chloroform, and with glacial acetic acid.
Kanamycin Sulfate: White, odorless, crystalline powder.
Freely soluble in water; insoluble in acetone, in ethyl acetate, and in benzene.
Kaolin: Soft, white or yellowish-white powder or lumps.
Has an earthy or clay-like taste and, when moistened with
water, assumes a darker color and develops a marked claylike odor. Insoluble in water, in cold dilute acids, and in
solutions of alkali hydroxides. NF category: Diluent; suspending and/or viscosity-increasing agent.
Ketamine Hydrochloride: White, crystalline powder,
having a slight, characteristic odor. Freely soluble in water
and in methanol; soluble in alcohol; sparingly soluble in
chloroform.
Ketorolac Tromethamine: White to off-white, crystalline powder. Melts between 165 and 170, with decomposition. Freely soluble in water and in methanol; slightly soluble in alcohol, in dehydrated alcohol, and in
tetrahydrofuran; practically insoluble in acetone, in dichloromethane, in toluene, in ethyl acetate, in dioxane, in hexane,
in butyl alcohol, and in acetonitrile.
Labetalol Hydrochloride: White to off-white powder.
Melts at about 180, with decomposition. Soluble in water
and in alcohol; insoluble in ether and in chloroform.

Official from December 1, 2014


Copyright (c) 2014 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 10.6.1.10 by Kalbe8 on Tue Dec 30 23:10:06 EST 2014

6994 Description and Solubility / Reference Tables


Alpha-Lactalbumin: Free-flowing, slightly hygroscopic
light cream-colored powder. Freely soluble in water; soluble
in wide pH ranges; insoluble in methanol, in alcohol, in
ether, and in acetone. NF category: Bulking agent; coating
agent; emulsifying agent; stiffening agent; suspending and/
or viscosity-increasing agent; diluent; wet binder; vehicle
(solid carrier); pH modifier (acidifying agent/alkalizing
agent/buffering agent); chelating and/or complexing agent.
Lactic Acid: Colorless or yellowish, practically odorless,
syrupy liquid. Is hygroscopic. When it is concentrated by
boiling, lactic acid lactate is formed. Specific gravity is about
1.20. Insoluble in chloroform. Miscible with water, with alcohol, and with ether. NF category: pH modifier (acidifying
agent/alkalizing agent/buffering agent).
Lactitol: A white or light brown, odorless crystal. Has a
mild, sweet taste, and no aftertaste. NF category: Flavors and
fragrance; diluent; sweetening agent.
Lactobionic Acid: White or almost white, crystalline
powder with a melting point of about 125 with decomposition. Freely soluble in water; slightly soluble in glacial acetic acid, in anhydrous ethanol, and in methanol. NF category: Antioxidant.
Anhydrous Lactose: White or almost white powder.
Freely soluble in water; practically insoluble in alcohol. NF
category: Diluent; carrier.
Lactose Monohydrate: White, free-flowing powder.
Freely but slowly soluble in water; practically insoluble in
alcohol. NF category: Diluent; carrier; wet binder.
Lactulose Concentrate: Colorless to amber syrupy liquid, which may exhibit some precipitation and darkening
upon standing. Miscible with water.
Lamivudine: White to off-white solid. Soluble in water.
Melts at about 176.
Lamotrigine: A white to pale cream-colored powder.
Slightly soluble in 0.1 N hydrochloric acid, in acetone, in
methanol, and in water.
Lanolin: Yellow, tenacious, unctuous mass, having a
slight, characteristic odor. Freely soluble in ether and in
chloroform; soluble in hot alcohol; sparingly soluble in cold
alcohol; insoluble in water, but mixes without separation
with about twice its weight of water. NF category: Emulsifying agent; ointment base.
Lanolin Alcohols: Hard, waxy, amber solid, having a
characteristic odor. Freely soluble in chloroform, in ether,
and in petroleum ether; slightly soluble in alcohol; insoluble
in water. NF category: Emulsifying agent; ointment base.
Lansoprazole: White to brownish-white powder. Freely
soluble in dimethylformamide; practically insoluble in water.
Melts at about 166, with decomposition.
Latanoprost: Colorless to slightly yellow oil. Very soluble in acetonitrile; freely soluble in acetone, in ethanol, in
ethyl acetate, in isopropanol, in methanol, and in octanol;
practically insoluble in water.
Add the following:
Lauric Acid:
White or faintly yellow, somewhat glossy,
crystalline solid or powder. Very soluble in alcohol, in ether,
and in methanol; soluble in acetone; practically insoluble in
water. NF category: Antifoaming agent; emulsifying and/or
solubilizing agent; tablet and/or capsule lubricant.NF32

Change to read:

Lauroyl Polyoxylglycerides: Pale yellow semi-solids.


Freely soluble in methylene chloride. Dispersible in
hot water. NF category: Ointment base; solvent; emulsifying
agent; wetting and/or solubilizing agent.
Lecithin: The consistency of both natural grades and
refined grades of lecithin may vary from plastic to fluid, de2S (NF32)

Second Supplement to USP 37NF 32


pending upon free fatty acid and oil content, and upon the
presence or absence of other diluents. Its color varies from
light yellow to brown, depending on the source, on crop
variations, and on whether it is bleached or unbleached. It is
odorless or has a characteristic, slight nut-like odor and a
bland taste. Practically insoluble in water, but it readily
hydrates to form emulsions. The oil-free phosphatides are
soluble in fatty acids, but are practically insoluble in fixed
oils. When all phosphatide fractions are present, lecithin is
sparingly soluble in alcohol and practically insoluble in acetone. NF category: Emulsifying agent; emollient.
Leflunomide: White to almost white powder. Freely soluble in methanol, in alcohol, in 2-propanol, in ethyl acetate,
in acetone, and in acetonitrile; practically insoluble in water.
Letrozole: White to yellowish, crystalline powder. Freely
soluble in dichloromethane; slightly soluble in alcohol; practically insoluble in water.
Leucine: White, practically odorless, tasteless crystals.
Sparingly soluble in water; insoluble in ether. NF category:
Flavors and fragrance.
Change to read:

Leucovorin Calcium: Yellowish-white or yellow USP37


powder. Slightly soluble to freely solubleUSP37 in water;
practically insoluble in alcohol.
Leucovorin Calcium Injection: Clear, yellowish solution.
Levamisole Hydrochloride: White or almost white,
crystalline powder. Freely soluble in water; soluble in alcohol; slightly soluble in methylene chloride; practically insoluble in ether.
Levetiracetam: White to almost white powder. Very
soluble in water; soluble in acetonitrile; practically insoluble
in hexane.
Levmetamfetamine: Clear, practically colorless liquid.
Levobunolol Hydrochloride: White crystalline, odorless
powder. Soluble in water and in methanol; slightly soluble
in alcohol and in chloroform.
Levocarnitine: White crystals or crystalline powder. Hygroscopic. Freely soluble in water, and in hot alcohol; practically insoluble in acetone, in ether, and in benzene.
Levodopa: White to off-white, odorless, crystalline powder. In the presence of moisture, is rapidly oxidized by atmospheric oxygen and darkens. Freely soluble in 3 N hydrochloric acid; slightly soluble in water; insoluble in alcohol.
Levofloxacin: Light yellowish-white to yellow-white
crystals or crystalline powder. Soluble in dimethylsulfoxide
and in acetic acid; sparingly soluble in water, in acetone,
and in methanol; practically insoluble in glycerin and in noctanol.
Levonordefrin: White to buff-colored, odorless, crystalline solid. Melts at about 210. Freely soluble in aqueous
solutions of mineral acids; slightly soluble in acetone, in
chloroform, in alcohol, and in ether; practically insoluble in
water.
Levonorgestrel: White or practically white, odorless
powder. Soluble in chloroform; slightly soluble in alcohol;
practically insoluble in water.
Levorphanol Tartrate: Practically white, odorless, crystalline powder. Sparingly soluble in water; slightly soluble in
alcohol; insoluble in chloroform and in ether. Melts, in a
sealed tube, at about 110, with decomposition.
Levothyroxine Sodium: Light yellow to buff-colored,
odorless, tasteless, hygroscopic powder. Is stable in dry air
but may assume a slight pink color upon exposure to light.
The pH of a saturated solution is about 8.9. Soluble in solutions of alkali hydroxides and in hot solutions of alkali carbonates; slightly soluble in alcohol; very slightly soluble in
water; insoluble in acetone, in chloroform, and in ether.

Official from December 1, 2014


Copyright (c) 2014 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 10.6.1.10 by Kalbe8 on Tue Dec 30 23:10:06 EST 2014

Second Supplement to USP 37NF 32


Lidocaine: White or slightly yellow, crystalline powder.
Has a characteristic odor and is stable in air. Very soluble in
alcohol and in chloroform; freely soluble in benzene and in
ether; practically insoluble in water. Dissolves in oils.
Lidocaine Hydrochloride: White, odorless, crystalline
powder, having a slightly bitter taste. Very soluble in water
and in alcohol; soluble in chloroform; insoluble in ether.
Lime: Hard, white or grayish-white masses or granules,
or white or grayish white powder. Is odorless. Slightly soluble in water; very slightly soluble in boiling water.
Lincomycin Hydrochloride: White or practically white,
crystalline powder. Is odorless or has a faint odor. Is stable
in the presence of air and light. Its solutions are acid and
dextrorotatory. Freely soluble in water; soluble in dimethylformamide; very slightly soluble in acetone.
Lincomycin Hydrochloride Injection: Clear, colorless to
slightly yellow solution, having a slight odor.
Lincomycin Hydrochloride Soluble Powder: White to
off-white, or light tan free-flowing, fine powder.
Lindane: White, crystalline powder, having a slight,
musty odor. Freely soluble in chloroform; soluble in dehydrated alcohol; sparingly soluble in ether; slightly soluble in
ethylene glycol; practically insoluble in water.
Linoleoyl Polyoxylglycerides: Amber, oily liquids. May
develop deposit after prolonged storage periods at 20.
Freely soluble in methylene chloride; practically insoluble
but dispersible in water. NF category: Ointment base; solvent; emulsifying agent; wetting and/or solubilizing agent.
Liothyronine Sodium: Light tan, odorless, crystalline
powder. Slightly soluble in alcohol; very slightly soluble in
water; practically insoluble in most other organic solvents.
Lisinopril: White, crystalline powder. Melts at about
160, with decomposition. Soluble in water; sparingly soluble in methanol; practically insoluble in alcohol, in acetone,
in acetonitrile, and in chloroform.
Lithium Carbonate: White, granular, odorless powder.
Sparingly soluble in water; very slightly soluble in alcohol.
Dissolves, with effervescence, in dilute mineral acids.
Lithium Citrate: White, odorless, deliquescent powder
or granules, having a cooling, faintly alkaline taste. Freely
soluble in water; slightly soluble in alcohol.
Lomustine: Yellow crystalline powder. Freely soluble in
acetone, and in methylene chloride; soluble in ethanol;
practically insoluble in water.
Loperamide Hydrochloride: White to slightly yellow
powder. Melts at about 225, with some decomposition.
Freely soluble in methanol and in chloroform; slightly soluble in water and in dilute acids; very slightly soluble in isopropyl alcohol.
Lopinavir: White powder. Freely soluble in methanol
and alcohol; soluble in isopropanol; practically insoluble in
water.
Loratadine: White to off-white powder. Freely soluble
in acetone, in chloroform, in methanol, and in toluene; insoluble in water.
Lorazepam: White or practically white, practically
odorless powder. Sparingly soluble in alcohol; slightly soluble in chloroform; insoluble in water.
Losartan Potassium: White to off-white powder. Freely
soluble in water; sparingly soluble in isopropyl alcohol;
slightly soluble in acetonitrile.
Lovastatin: White to off-white, crystalline powder.
Freely soluble in chloroform; soluble in acetone, in acetonitrile, and in methanol; sparingly soluble in alcohol; practically insoluble in hexane; insoluble in water.
Loxapine Succinate: White to yellowish, crystalline
powder. Is odorless.

Reference Tables / Description and Solubility 6995


Add the following:
Lumefantrine:
Yellow crystalline powder. Freely soluble in N,N-dimethylformamide, in chloroform, and in ethyl
acetate; soluble in dichloromethane; slightly soluble in ethanol and in methanol; practically insoluble in water.USP37
Lutein: Red, crystalline powder. Soluble in ethanol, in
ethyl acetate, and in methylene chloride; partially soluble in
hexane.
Lysine Acetate: White, odorless crystals or crystalline
powder, having an acid taste. Freely soluble in water.
Lysine Hydrochloride: White, odorless powder. Freely
soluble in water. NF category: pH modifier (acidifying agent/
alkalizing agent/buffering agent).
Mafenide Acetate: White to pale yellow, crystalline
powder. Freely soluble in water.
Magaldrate: White, odorless, crystalline powder. Soluble in dilute solutions of mineral acids; insoluble in water
and in alcohol.
Milk of Magnesia: White, opaque, more or less viscous
suspension from which varying proportions of water usually
separate on standing. pH is about 10.
Magnesium Aluminometasilicate: White powder or
granules having an amorphous structure. Very slightly soluble in acids and in alkalies; practically insoluble in water and
in alcohol.
Magnesium Aluminosilicate: White powder or granules
having an amorphous structure. Very slightly soluble in acids
and in alkalies; practically insoluble in water and in alcohol.
Magnesium Aluminum Silicate: Odorless, tasteless, fine
(micronized) powder, small cream to tan granules, or small
flakes that are creamy when viewed on their flat surfaces
and tan to brown when viewed on their edges. Insoluble in
water and in alcohol. Swells when added to water or glycerin. NF category: Suspending and/or viscosity-increasing
agent; disintegrant.
Magnesium Carbonate: Light, white, friable masses or
bulky, white powder. Is odorless, and is stable in air. Practically insoluble in water to which, however, it imparts a
slightly alkaline reaction; insoluble in alcohol, but is dissolved by dilute acids with effervescence. NF category: Diluent.
Magnesium Chloride: Colorless, odorless, deliquescent
flakes or crystals, which lose water when heated to 100
and lose hydrochloric acid when heated to 110. Very soluble in water; freely soluble in alcohol.
Magnesium Citrate Oral Solution: Colorless to slightly
yellow, clear, effervescent liquid, having a sweet, acidulous
taste and a lemon flavor.
Magnesium Gluconate: Colorless crystals or white
powder or granules. Is odorless and tasteless. Freely soluble
in water; very slightly soluble in alcohol; insoluble in ether.
Magnesium Hydroxide: Bulky, white powder. Soluble
in dilute acids; practically insoluble in water and in alcohol.
Magnesium Oxide: Very bulky, white powder or relatively dense, white powder or granulated powder. Soluble in
dilute acids; practically insoluble in water; insoluble in alcohol. NF category: Emulsifying agent; glidant and/or anticaking agent; diluent.
Magnesium Phosphate: White, odorless, tasteless powder. Soluble in diluted mineral acids; practically insoluble in
water.
Magnesium Salicylate: White, odorless, efflorescent,
crystalline powder. Freely soluble in methanol; soluble in alcohol and in water; slightly soluble in ether.
Magnesium Silicate: Fine, white, odorless, tasteless
powder, free from grittiness. Insoluble in water and in alcohol. Is readily decomposed by mineral acids. NF category:
Glidant and/or anticaking agent.

Official from December 1, 2014


Copyright (c) 2014 The United States Pharmacopeial Convention. All rights reserved.

Vous aimerez peut-être aussi