Neomycin Sulfate Oral Solution, chemical structure, molecular formula, Reference Standards

Neomycin Sulfate Oral Solution

»Neomycin Sulfate Oral Solution contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of neomycin.It may contain one or more suitable colors,flavors,and preservatives.

Packaging and storage— Preserve in tight,light-resistant containers,preferably at controlled room temperature.

USP Reference standards á11ñ— USP Neomycin Sulfate RS.

Thin-layer chromatographic identification test á201BNPñ: meets the requirements.

Add the following:

Uniformity of dosage units á905ñ—

FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

USP28

Add the following:

Deliverable volume á698ñ—

FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

USP28

pHá791ñ: between 5.0and 7.5.

Assay— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Oral Solution quantitatively diluted with Buffer No.3to yield a solution having a convenient concentration of neomycin.Quantitatively dilute this stock solution with Buffer No.3to 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 1343

Pharmacopeial Forum:Volume No.30(1)Page 133

Phone Number:1-301-816-8335