U.S. PHARMACOPEIA

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Sterile Vancomycin Hydrochloride
» Sterile Vancomycin Hydrochloride has a potency equivalent to not less than 900 µg of vancomycin per mg, calculated on the anhydrous basis. In addition, where packaged for dispensing, it contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of vancomycin.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85— It contains not more than 0.33 USP Endotoxin Unit per mg of vancomycin hydrochloride.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, except to dissolve the specimen in water, instead of in Fluid A.
Particulate matter 788: meets the requirements under small-volume injections.
Heavy metals, Method II 231: not more than 0.003%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It responds to the Identification test and meets the requirements of the tests for pH, Water, and Chromatographic purity under Vancomycin Hydrochloride. It meets also the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Assay—
Assay preparation 1— Dissolve a suitable quantity of Sterile Vancomycin Hydrochloride, accurately weighed, in water, and dilute quantitatively with water to obtain a solution containing about 1 mg of vancomycin per mL.
Assay preparation 2 (where it is packaged for dispensing)—Dissolve the contents of 1 container of Sterile Vancomycin Hydrochloride in water, and dilute quantitatively with water to obtain a solution having a concentration of about 1 mg of vancomycin per mL.
Assay preparation 3 (where the label states the quantity of vancomycin in a given volume of constituted solution)—Constitute 1 container of Sterile Vancomycin Hydrochloride in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution having a concentration of about 1 mg of vancomycin per mL.
Procedure— Proceed as directed under Antibiotics—Microbial Assays 81, using an accurately measured volume of the appropriate Assay preparation diluted quantitatively with Buffer No. 4 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 2241
Pharmacopeial Forum : Volume No. 27(4) Page 2786
Phone Number : 1-301-816-8223