Vancomycin Hydrochloride for Oral Solution
DEFINITION
Vancomycin Hydrochloride for Oral Solution contains the equivalent of NLT 90.0% and NMT 115.0% of the labeled amount of vancomycin (C66H75Cl2N9O24).
ASSAY
• Antibiotics—Microbial Assays 
81
81
Sample solution:
Dissolve the contents of 1 container of Vancomycin Hydrochloride for Oral Solution in water as directed in the labeling. Dilute a portion of this 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.
Analysis:
Proceed as directed for vancomycin in the chapter.
Acceptance criteria:
90.0%–115.0%
PERFORMANCE TESTS
• Uniformity of Dosage Units 905
905
For powder packaged in single-unit containers:
Meets the requirements
• Deliverable Volume 698
698
For powder packaged in multiple-unit containers:
Meets the requirements
SPECIFIC TESTS
• pH 791:
2.5–4.5, for a solution constituted as directed in the labeling
791:
2.5–4.5, for a solution constituted as directed in the labeling
• Water Determination, Method I 921:
NMT 5.0%
921:
NMT 5.0%
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 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 5005
Pharmacopeial Forum: Volume No. 30(1) Page 193