Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Vancomycin Hydrochloride RS.

Identification— Place 1or more Capsules in a high-speed glass blender jar containing a volume of water sufficient to yield a solution containing the equivalent of 1mg of vancomycin per mL,and blend for 3to 5minutes.To a suitable sheet of chromatographic filter paper apply 5µLof this solution and 5µLof a solution of USP Vancomycin Hydrochloride RScontaining the equivalent of 1mg of vancomycin per mL.Develop by descending chromatography (see Chromatography á621ñ)with a mixture of butyl alcohol,water,and pyridine (6:4:3)for 7hours.Allow the paper to dry,and place it on an inoculated agar surface of sufficient area to accommodate the paper and prepared for vancomycin assay as directed under Antibiotics—Microbial Assays á81ñ,except to use Medium 2.Remove the paper from the agar surface after 30minutes,and incubate the agar medium at 37for 18hours:clear zones of inhibition are produced at corresponding positions on the two chromatograms.

Dissolution á711ñ—

Uniformity of dosage units á905ñ: meet the requirements.

Water,Method Iá921ñ: not more than 8.0%.

Assay— Proceed as directed for vancomycin under Antibiotics—Microbial Assays á81ñ,using not less than 5Capsules blended at high speed in a glass blender jar for 3to 5minutes with a sufficient,accurately measured,volume of Buffer No.4to yield a stock solution having a convenient concentration of vancomycin.Dilute an accurately measured volume of this stock solution quantitatively and stepwise with Buffer No.4to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 2014

Phone Number:1-301-816-8335