Vancomycin Injection
»Vancomycin Injection is a sterile isoosmotic solution of Vancomycin Hydrochloride in Water for Injection.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of vancomycin.It contains a suitable tonicity-adjusting agent.
Packaging and storage— Preserve in Containers for Injectionsas described under Injections á1ñ.Maintain in the frozen state.
Labeling— It meets the requirements for Labelingunder Injections á1ñ.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 Aobtained as directed in the test for Chromatographic puritycorresponds to that in the chromatogram of a similar preparation of USP Vancomycin Hydrochloride RSsimilarly chromatographed.
Bacterial endotoxins á85ñ— It contains not more than 0.33USP Endotoxin Unit per mg of vancomycin.
Sterility á71ñ— It meets the requirements when tested as directed forMembrane Filtrationunder Test for Sterility of the Product to be Examined,except to use water instead of Diluting Fluid A.
pHá791ñ: between 3.0and 5.0.
Particulate matter á788ñ: 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 purityunder 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 0.5mg of vancomycin per mL,heat at 65for 24hours,and allow to cool.
Test preparation A— Allow a container of Injection to thaw,and mix the solution.
Test preparation B— Transfer 2.0mLof Test preparation Ato a 50-mLvolumetric flask,dilute with Solution Ato volume,and mix.
Procedure— Proceed as directed for Procedurein the test for Chromatographic purityunder Vancomycin Hydrochloride.Calculate the percentage of vancomycin Bin the specimen taken by the formula:
2500rB/(25rB+rA),
in which the terms are as defined therein:not less than 88%of vancomycin Bis 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.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Proceed as directed for Vancomycin under Antibiotics—Microbial Assays á81ñ,preparing the Test Dilutionas follows.Allow a container of Injection to thaw,and mix the solution.Dilute an accurately measured portion of this solution quantitatively with Buffer No.4to yield a Test Dilutionhaving a concentration assumed to be equal to that of the median dose of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 2014
Pharmacopeial Forum:Volume No.27(4)Page 2784
Phone Number:1-301-816-8335
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