U.S. PHARMACOPEIA

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Vancomycin Injection
» Vancomycin Injection is a sterile isoosmotic solution of Vancomycin Hydrochloride in Water for Injection. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of vancomycin. It contains a suitable tonicity-adjusting agent.
Packaging and storage— Preserve in Containers for Injections as described under Injections 1. Maintain in the frozen state.
Labeling— It meets the requirements for Labeling under Injections 1. The label states that it is to be thawed just prior to use, describes conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
Identification— The retention time of the main vancomycin peak in the chromatogram of Test preparation A obtained as directed in the test for Chromatographic purity corresponds to that in the chromatogram of a similar preparation of USP Vancomycin Hydrochloride RS similarly chromatographed.
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 use water instead of Diluting Fluid A.
pH 791: between 3.0 and 5.0.
Particulate matter 788: meets the requirements under small-volume injections.
Chromatographic purity—
Triethylamine buffer , Solution A, Solution B, Moble phase, and Chromatographic system—Prepare as directed in the test for Chromatographic purity under Vancomycin Hydrochloride.
Resolution solution— Allow a container of Injection to thaw, and mix the solution. Dilute a portion of the solution with water to obtain a solution containing 0.5 mg of vancomycin per mL, heat at 65 for 24 hours, and allow to cool.
Test preparation A— Allow a container of Injection to thaw, and mix the solution.
Test preparation B— Transfer 2.0 mL of Test preparation A to a 50-mL volumetric flask, dilute with Solution A to volume, and mix.
Procedure— Proceed as directed for Procedure in the test for Chromatographic purity under Vancomycin Hydrochloride. Calculate the percentage of vancomycin B in the specimen taken by the formula:
2500rB / (25rB + rA),
in which the terms are as defined therein: not less than 88% of vancomycin B is found.
Calculate the percentage of any individual peak, other than the main peak, by the formula:
100rAi / (25rB + rA),
in which the terms are as defined therein: not more than 4% of any peak other than the main peak is found.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Proceed as directed for Vancomycin under Antibiotics—Microbial Assays 81, preparing the Test Dilution as follows. Allow a container of Injection to thaw, and mix the solution. Dilute an accurately measured portion of this solution quantitatively with Buffer No. 4 to yield a Test Dilution having a concentration assumed to be equal to that of the median dose 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 2784
Phone Number : 1-301-816-8223