U.S. PHARMACOPEIA

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Vancomycin Hydrochloride for Injection
» Vancomycin Hydrochloride for Injection is a sterile dry mixture of Vancomycin Hydrochloride and a suitable stabilizing agent. It has a potency equivalent to not less than 925 µg of vancomycin per mg, calculated on the anhydrous basis. In addition, it contains 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.
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%.
Chromatographic purity—
Triethylamine buffer , Solution A, Solution B, Mobile phase, Resolution solution, and Chromatographic system—Prepare as directed in the test for Chromatographic purity under Vancomycin Hydrochloride.
Test preparation A— Prepare a solution of Vancomycin Hydrochloride for Injection in Solution A containing 10 mg of vancomycin per mL.
Test preparation B— Transfer 2.0 mL of Test preparation A to a 50-mL flask, dilute with Solution A to volume, and mix.
Procedure— Proceed as directed for Procedure under Vancomycin Hydrochloride. Not less than 88.0% of vancomycin B is found, and not more than 4.0% of any peak other than the main peak is found.
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 and Water under Vancomycin Hydrochloride. It also meets the requirements for Uniformity of Dosage Units 905 and Labeling under Injections 1.
Assay—
Assay preparation 1 (for determining the µg of vancomycin equivalent per mg)—Dissolve a suitable quantity of Vancomycin Hydrochloride for Injection, 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 represented as being in a single-dose container)—Constitute a container of Vancomycin Hydrochloride for Injection in a volume of water, accurately measured, corresponding to the volume of diluent specified in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with water to obtain a solution containing 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 a container of Vancomycin Hydrochloride for Injection in a volume of water, accurately measured, equivalent to the volume of diluent specified in the labeling. Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution containing 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 2240
Pharmacopeial Forum : Volume No. 27(4) Page 2785
Phone Number : 1-301-816-8223