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Vancomycin Hydrochloride Capsules
» Vancomycin Hydrochloride Capsules contain the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of vancomycin (C66H75Cl2N9O24).
Packaging and storage— Preserve in tight containers.
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
Medium: water; 900 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
Procedure— Determine the amount of vancomycin dissolved by assaying a filtered portion of the solution under test as directed for vancomycin under Antibiotics—Microbial Assays 81.
Tolerances— Not less than 85% (Q) of the labeled amount of vancomycin is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 8.0%.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
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.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 2240
Phone Number : 1-301-816-8223