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USP 35
STERILITY TESTS 71: Meets the requirements
PARTICULATE MATTER IN INJECTIONS 788: Meets the
requirements
OTHER REQUIREMENTS: It meets the requirements under
Injections 1.
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in single-dose or multipledose containers in T ype I glass. Store between 20 and 25 ,
excursions permitted between 15 and 30 .
LABELING: Label it to indicate the amount (mg) of
Enoxaparin Sodium in the total volume of contents. The
label states also that the Enoxaparin Sodium starting material
is porcine derived.
USP REFERENCE STANDARDS 11
USP Benzyl Alcohol RS
USP Endotoxin RS
USP Enoxaparin Sodium RS
USP Enoxaparin Sodium Solution for Bioassays RS
Enrofloxacin
C19H22FN3O3 359.39
3-Quinolinecarboxylic acid, 1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-;
1-Cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4oxo-3-quinolinecarboxylic acid
[93106-60-6].
Enrofloxacin contains not less than 98.5 percent and not more than 101.5 per cent of
C19H22FN3O3, calculated on the dried basis.
Packaging and storagePreserve in well-closed, tight, lightresistant containers.
LabelingLabel it to indicate that it is for veterinar y use only.
USP Reference standards 11
USP Enrofloxacin RS
USP Fluoroquinolonic Acid RS
USP N-Ethylpiperazine RS
USP Enrofloxacin Related Compound Mixture RS
Contains a mixture of USP Enrofloxacin RS, desfluoro-enrofloxacin, and USP Ciprofloxacin RS.
Desfluoro-enrofloxacin:1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-1,4-dihydro-4-oxo-3-quinoline-carboxylic acid.
Clarity of solution
Hydrazine sulfate solutionTransfer 1.0 g of hydrazine sulfate
to a 100-mL volumetric flask, dissolve in and dilute with water
to volume, and mix. Allow to stand for 4 to 6 hours.
Hexamethylenetetramine solutionTransfer 2.5 g of hexamethylenetetramine to a 100-mL volumetric flask, add 25.0
mL of water, insert a glass stopper, and mix to dissolve.
Primary opalescent suspension[NOTEThis suspension is stable for 2 months, provided it is stored in a glass container free
from surface defects. The suspension must not adhere to the
glass and must be well-mixed before use.] Transfer 25.0 mL of
the Hydrazine sulfate solution to the Hexamethylenetetramine solution in the 100-mL glass-stoppered flask. Mix, and allow to
stand for 24 hours.
Opalescence standard[NOTEThis suspension should not be
used beyond 24 hours after preparation.] Transfer 15.0 mL of
the Primary opalescent suspension to a 1000-mL volumetric flask,
dilute with water to volume, and mix.
USP 35
USP 35
than 0.1% of any unspecified impurity, and not more than
0.5% of total impurities are found.
AssayTransfer about 250 mg of Enrofloxacin, accurately
weighed, to a 125-mL flask, dissolve in 100 mL of anhydrous
acetic acid, and titrate with 0.1 M per chloric acid VS, determining the endpoint potentiometrically. Per form a blank determination, and make any necessar y correction. Each mL of 0.1 M
perchloric acid is equivalent to 35.94 mg of C 19H22FN3O3.
Ensulizole
.
C13H10N2O3S
1H-Benzimidazole-5-sulfonic acid-2-phenyl-;
2-Phenylbenzimidazole-5-sulfonic acid [27503-81-7].
274.30
DEFINITION
Ensulizole contains NLT 98.0% and NMT 102.0% of
C13H10N2O3S, calculated on the dried basis.
IDENTIFICATION
A. INFRARED ABSORPTION 197K
B. ULTRAVIOLET ABSORPTION 197U
Sample solution: 5 g/mL
[NOTETransfer 100 mg of Ensulizole to a 100-mL volumetric flask, dissolve in 4 mL of 1 N sodium hydroxide, and
dilute with water to volume. T ransfer 0.5 mL of the solution to a 100-mL volumetric flask, and dilute with water
to volume.]
Acceptance criteria: The absorptivities, calculated on the
dried basis, at the wavelength of maximum absorbance at
about 302 nm, do not differ by more than 3.0%.
ASSAY
PROCEDURE
Sample solution: 48 mg/mL of Ensulizole in 0.5 N sodium
hydroxide
Titrant: 0.5 N hydrochloric acid VS
Analysis: To the Sample solution, add phenolphthalein TS,
and titrate the excess with Titrant. Perform a blank determination, and make any necessar y corrections (see Titrimetry
541). Each mL of 0.5 N sodium hydroxide is equivalent to
137.15 mg of C 13H10N2O3S.
Calculate the per centage of C 13H10N2O3S in the portion of
Ensulizole taken:
Result = [(N (V B V A))/(W (1 LOD))] M r1 100
N
VB
VA