Oxacillin Sodium Capsules
»Oxacillin Sodium Capsules contain the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of oxacillin (C19H19N3O5S).
Packaging and storage— Preserve in tight containers,at controlled room temperature.
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.
Dissolution á711ñ
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of oxacillin (C19H19N3O5S)by a suitable validated spectrophotometric analysis of a filtered portion of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Oxacillin Sodium RSin the same medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C19H19N3O5Sis dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 6.0%.
Assay—
Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Oxacillin Sodium.
Assay preparation— Remove,as completely as possible,the contents of not less than 10Capsules,and weigh.Mix,and transfer an accurately weighed portion of the powder,equivalent to about 100mg of oxacillin (C19H19N3O5S),to a 200-mLvolumetric flask,add water to volume,and mix for 10minutes with the aid of a magnetic stirrer.Filter about 25mLof the resulting solution,discarding the first 5mLof the filtrate.Transfer 10.0mLof the clear filtrate to a 50-mLvolumetric flask,dilute with water to volume,and mix.[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 the portion of Capsule contents taken by the formula:
CE(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1424
Phone Number:1-301-816-8335