Vancomycin Hydrochloride for Oral Solution, chemical structure, molecular formula, Reference Standards

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.

USP Reference standards á11ñ— USP Vancomycin Hydrochloride RS.

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