Vancomycin Hydrochloride for Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Vancomycin Hydrochloride for Oral Solution contains the equivalent of NLT 90.0% and NMT 115.0% of the labeled amount of vancomycin (C₆₆H₇₅Cl₂N₉O₂₄).

2 ASSAY

2.1 Antibiotics-Microbial Assays 〈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 B.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%

3 PERFORMANCE TESTS

3.1 Uniformity of Dosage Units 〈905〉

For powder packaged in single-unit containers: Meets the requirements

3.2 Deliverable Volume 〈698〉

For powder packaged in multiple-unit containers: Meets the requirements

4 SPECIFIC TESTS

pH 〈791〉: 2.5–4.5, for a solution constituted as directed in the labeling

Water Determination, Method I〈921〉: NMT 5.0%

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Vancomycin Hydrochloride RS