» 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.
Triethylamine buffer , Solution A, Solution B, Mobile phase, and Chromatographic systemPrepare 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.
Other requirements It meets the requirements under Injections 1.
Assay Proceed as directed for Vancomycin under AntibioticsMicrobial 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 Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 3847Pharmacopeial Forum: Volume No. 27(4) Page 2784
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.