Vancomycin Hydrochloride for Oral Solution
»Vancomycin Hydrochloride for Oral Solution contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of vancomycin.
Packaging and storage— Preserve in tight containers.
Add the following:
Uniformity of dosage units á905ñ
FOR POWDER PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.USP28
Add the following:
Deliverable volume á698ñ
FOR POWDER PACKAGED IN MULTIPLE-UNIT CONTAINERS:
meets the requirements.USP28
pHá791ñ: between 2.5and 4.5,for the solution constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 5.0%.
Assay— Proceed as directed under Antibiotics—Microbial Assays á81ñ,dissolving the contents of 1container of Vancomycin Hydrochloride for Oral Solution in water as directed in the labeling.Dilute a portion of this solution quantitatively with Buffer No.4to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 2015
Pharmacopeial Forum:Volume No.30(1)Page 193
Phone Number:1-301-816-8335