Vancomycin Hydrochloride Capsules
DEFINITION
Vancomycin Hydrochloride Capsules contain the equivalent of NLT 90.0% and NMT 115.0% of the labeled amount of vancomycin (C66H75Cl2N9O24).
IDENTIFICATION
• Infrared Absorption 
197K
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.
for 1 h.
ASSAY
• Antibiotics—Microbial Assays 81
81
Analysis:
Proceed as directed, using NLT 5 Capsules blended at high speed in a glass blender jar for 3–5 min with a sufficient volume of Buffer No. 4 to yield a stock solution having a convenient concentration of vancomycin. Dilute a volume of this stock solution with Buffer No. 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%
PERFORMANCE TESTS
• Dissolution 711
711
Medium:
Water; 900 mL
Apparatus 1:
100 rpm
Time:
45 min
Sample solution:
Sample per Dissolution 711
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.
81.
Tolerances:
NLT 85% (Q) of the labeled amount of vancomycin is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
SPECIFIC TESTS
• Water Determination, Method I 921:
NMT 8.0%
921:
NMT 8.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• USP Reference Standards 11
11
USP Vancomycin Hydrochloride RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 5002
Pharmacopeial Forum: Volume No. 34(6) Page 1487