Vancomycin Hydrochloride for Oral Solution
Vancomycin Hydrochloride for Oral Solution contains the equivalent of NLT 90.0% and NMT 115.0% of the labeled amount of vancomycin (C66H75Cl2N9O24).
• AntibioticsMicrobial 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 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%
• Uniformity of Dosage Units 905
For powder packaged in single-unit containers: Meets the requirements
• Deliverable Volume 698
For powder packaged in multiple-unit containers: Meets the requirements
• pH 791: 2.54.5, for a solution constituted as directed in the labeling
• Water Determination, Method I 921: NMT 5.0%
• Packaging and Storage: Preserve in tight containers.
• USP Reference Standards 11
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USP35NF30 Page 5005Pharmacopeial Forum: Volume No. 30(1) Page 193