Oxacillin Sodium for Oral Solution
» Oxacillin Sodium for Oral Solution contains the equivalent of not less than 90.0 percent and not more than 120.0 percent 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.
Identification The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for oxacillin, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Uniformity of dosage units 905
for solid packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 5.0 and 7.5, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 1.0%.
Mobile phase and Chromatographic systemProceed as directed in the Assay under Oxacillin Sodium.
Diluent Prepare a mixture of water and acetonitrile (700:300).
Standard preparation Prepare a solution of USP Oxacillin Sodium RS in Diluent having a known concentration of about 0.11 mg per mL. [noteUse 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 250 mg of oxacillin (C19H19N3O5S), to a 250-mL volumetric flask, dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with Diluent to volume, and mix. Filter about 5 mL of this solution through a 0.5-µm or finer porosity filter, discarding the first 2 mL of the filtrate. Use the clear filtrate as the Assay preparation. [noteUse this Assay preparation on the day prepared.]
Procedure Proceed as directed for Procedure in the Assay under Oxacillin Sodium. Calculate the quantity, in mg, of oxacillin (C19H19N3O5S) in each mL of the constituted Oxacillin Sodium for Oral Solution taken by the formula:
2.5(CE / V)(rU / rS)in which V is the volume, in mL, of the constituted Oxacillin Sodium for Oral Solution taken, and the other terms are as defined therein.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 3149
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.