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Ultramicrosize Griseofulvin Tablets
» Ultramicrosize Griseofulvin Tablets are composed of ultramicrosize crystals of Griseofulvin dispersed in Polyethylene Glycol 6000 or dispersed by other suitable means. They contain not less than 90.0 percent and not more than 115.0 percent of the labeled amount of griseofulvin (C17H17ClO6).
Packaging and storage— Preserve in well-closed containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution 711—
Medium: water containing 5.4 mg of sodium lauryl sulfate per mL; 1000 mL.
Apparatus 2: 75 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C17H17ClO6 dissolved from UV absorbances at the wavelength of maximum absorbance at about 291 nm of filtered portions of the solution under test, suitably diluted with a solution of methanol and water (4:1), if necessary, in comparison with a Standard solution having a known concentration of USP Griseofulvin RS in the same medium.
Tolerances— Not less than 80% (Q) of the labeled amount of C17H17ClO6 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Procedure for content uniformity— Proceed as directed for Procedure for content uniformity in the test for Uniformity of dosage units under Griseofulvin Tablets.
Loss on drying 731— Dry about 100 mg of finely ground Tablets, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 5.0% of its weight.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Griseofulvin.
Assay preparation— Weigh and finely powder not less than 20 Tablets and proceed as directed for Assay preparation in the Assay under Griseofulvin Capsules, beginning with “transfer an accurately weighed portion.”
Procedure— Proceed as directed for Procedure in the Assay under Griseofulvin. Calculate the quantity, in mg, of griseofulvin (C17H17ClO6) in the portion of Tablets taken by the formula:
PC(rU / rS),
in which C is the concentration, in mg per mL, of USP Griseofulvin RS in the Standard preparation, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1028
Phone Number : 1-301-816-8223