Nafcillin Sodium for Oral Solution, chemical structure, molecular formula, Reference Standards

Nafcillin Sodium for Oral Solution

»Nafcillin Sodium for Oral Solution contains not less than 90.0percent and not more than 120.0percent of the labeled amount of nafcillin (C21H22N2O5S).It contains one or more suitable buffers,colors,diluents,dispersants,flavors,and preservatives.

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Nafcillin Sodium RS.

Uniformity of dosage units á905ñ—

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

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 5.5and 7.5,in 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,using Nafcillin Sodium for Oral Solution constituted as directed in the labeling.Dilute an accurately measured volume of the solution quantitatively with Buffer No.1to 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 1324

Phone Number:1-301-816-8335