Dicloxacillin Sodium Capsules
» Dicloxacillin Sodium Capsules contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of dicloxacillin (C19H17Cl2N3O5S).
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Dicloxacillin Sodium RS Click to View Structure
Identification— The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for dicloxacillin, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Dissolution 711
Medium: water; 900 mL.
Apparatus 1: 100 rpm.
Time: 30 minutes.
Procedure— Determine the amount of dicloxacillin (C19H17Cl2N3O5S) 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 Dicloxacillin Sodium RS in the same Medium.
Tolerances— Not less than 75% (Q) of the labeled amount of C19H17Cl2N3O5S is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 5.0%.
Diluent, Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Dicloxacillin Sodium.
Assay preparation— Remove, as completely as possible, the contents of not fewer than 10 Capsules, and weigh. Mix, and transfer an accurately weighed portion of the powder, equivalent to about 200 mg of dicloxacillin (C19H17Cl2N3O5S), to a 200-mL volumetric flask, dilute with Diluent to volume, and mix for 10 minutes with the aid of a magnetic stirrer. Filter about 25 mL of the resulting solution, discarding the first 5 mL of the filtrate. Use the clear filtrate as the Assay preparation. [note—Use this Assay preparation promptly, or refrigerate and use on the day prepared. ]
Procedure— Proceed as directed for Procedure in the Assay under Dicloxacillin Sodium. Calculate the quantity, in mg, of dicloxacillin (C19H17Cl2N3O5S) in the portion of Capsule contents taken by the formula:
0.2CE(rU / rS)
in which the terms are as defined therein.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
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(SM12010) Monographs - Small Molecules 1
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711 Margareth R.C. Marques, Ph.D.
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(GCDF2010) General Chapters - Dosage Forms
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