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.
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 AntibioticsMicrobial 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