Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Vancomycin Hydrochloride RS.

Identification— Place 1 or more Capsules in a high-speed glass blender jar containing a volume of water sufficient to yield a solution containing the equivalent of 1 mg of vancomycin per mL, and blend for 3 to 5 minutes. To a suitable sheet of chromatographic filter paper apply 5 µL of this solution and 5 µL of a solution of USP Vancomycin Hydrochloride RS containing the equivalent of 1 mg of vancomycin per mL. Develop by descending chromatography (see Chromatography 621) with a mixture of butyl alcohol, water, and pyridine (6:4:3) for 7 hours. 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 81, except to use Medium 2. Remove the paper from the agar surface after 30 minutes, and incubate the agar medium at 37 for 18 hours: clear zones of inhibition are produced at corresponding positions on the two chromatograms.

Dissolution 711—

Uniformity of dosage units 905: meet the requirements.

Water, Method I 921: not more than 8.0%.

Residual solvents 467: meet the requirements.

Assay— Proceed as directed for vancomycin under Antibiotics—Microbial Assays 81, using not less than 5 Capsules blended at high speed in a glass blender jar for 3 to 5 minutes with a sufficient, accurately measured, volume of Buffer No. 4 to 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. 4 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 2240

Phone Number : 1-301-816-8223