Vancomycin Hydrochloride for Oral Solution
» Vancomycin Hydrochloride for Oral Solution contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of vancomycin.
Packaging and storage Preserve in tight containers.
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: between 2.5 and 4.5, for the solution constituted as directed in the labeling.
Water, Method I 921: not more than 5.0%.
Assay Proceed as directed under AntibioticsMicrobial Assays 81, dissolving the contents of 1 container of Vancomycin Hydrochloride for Oral Solution in water as directed in the labeling. Dilute a portion of this solution quantitatively with Buffer No. 4 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP32NF27 Page 3848Pharmacopeial Forum: Volume No. 30(1) Page 193