Vancomycin Hydrochloride Capsules
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Vancomycin Hydrochloride Capsules contain the equivalent of NLT 90.0% and NMT 115.0% of the labeled amount of vancomycin (C₆₆H₇₅Cl₂N₉O₂₄).
2 IDENTIFICATION
Change to read:
Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K
Sample: Disperse the contents of 1 Capsule in about 20 mL of chloroform. Pass the liquid through a suitable filter. Rinse the filter and residue with chloroform. Dry the residue in a vacuum at 60° for 1 h.
3 ASSAY
3.1 Antibiotics-Microbial Assays 〈81〉
Analysis: Proceed as directed, using NLT 5 Capsules blended at high speed in a glass blender jar for 3–5 min with a suficient volume of Buffer B.4 to yield a stock solution having a convenient concentration of vancomycin. Dilute a volume of this stock solution with Buffer B.4 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Acceptance criteria: 90.0%–115.0%
4 PERFORMANCE TESTS
4.1 Dissolution 〈711〉
Medium: Water; 900 mL
Apparatus 1: 100 rpm
Time: 45 min
Sample solution: Sample per Dissolution 〈711〉
Analysis: Determine the amount of vancomycin dissolved by assaying a filtered portion of the Sample solution as directed for vancomycin under Antibiotics—Microbial Assays 〈81〉.
Tolerances: NLT 85% (Q) of the labeled amount of vancomycin is dissolved.
4.2 Uniformity of Dosage Units 〈905〉
Meet the requirements
5 SPECIFIC TESTS
Water Determination, Method I 〈921〉: NMT 8.0%
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight containers.
USP Reference Standards 〈11〉
USP Vancomycin Hydrochloride RS
