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

Oxacillin Sodium for Oral Solution

»Oxacillin Sodium for Oral Solution contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of oxacillin (C19H19N3O5S).It contains one or more suitable buffers,colors,flavors,preservatives,and stabilizers.

Packaging and storage— Preserve in tight containers at controlled room temperature.

USP Reference standards á11ñ— USP Oxacillin Sodium RS.

Identification— The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for oxacillin,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.

Uniformity of dosage units á905ñ—

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

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 5.0and 7.5,in the solution constituted as directed in the labeling.

Water,Method Iá921ñ: not more than 1.0%.

Assay—

Mobile phase and Chromatographic system—Proceed as directed in the Assayunder Oxacillin Sodium.

Diluent— Prepare a mixture of water and acetonitrile (700:300).

Standard preparation— Prepare a solution of USP Oxacillin Sodium RSin Diluenthaving a known concentration of about 0.11mg per mL.[NOTE—Use this solution on the day prepared.]

Assay preparation— Transfer an accurately measured volume of Oxacillin Sodium for Oral Solution,constituted as directed in the labeling,equivalent to about 250mg of oxacillin (C19H19N3O5S),to a 250-mLvolumetric flask,dilute with water to volume,and mix.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,dilute with Diluentto volume,and mix.Filter about 5mLof this solution through a 0.5-µm or finer porosity filter,discarding the first 2mLof the filtrate.Use the clear filtrate as the Assay preparation.[NOTE—Use this Assay preparation on the day prepared.]

Procedure— Proceed as directed for Procedurein the Assayunder Oxacillin Sodium.Calculate the quantity,in mg,of oxacillin (C19H19N3O5S)in each mLof the constituted Oxacillin Sodium for Oral Solution taken by the formula:

2.5(CE/V)(rU/rS),

in which Vis the volume,in mL,of the constituted Oxacillin Sodium for Oral Solution taken,and the other terms are as defined therein.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1426

Phone Number:1-301-816-8335