Ultramicrosize Griseofulvin Tablets
»Ultramicrosize Griseofulvin Tablets are composed of ultramicrosize crystals of Griseofulvin dispersed in Polyethylene Glycol 6000or dispersed by other suitable means.They contain not less than 90.0percent and not more than 115.0percent 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 preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Dissolution á711ñ—
Medium: water containing 5.4mg of sodium lauryl sulfate per mL;1000mL.
Apparatus 2: 75rpm.
Time: 45minutes.
Procedure— Determine the amount of C17H17ClO6dissolved from UVabsorbances at the wavelength of maximum absorbance at about 291nm 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 RSin the same medium.
Tolerances— Not less than 80%(Q)of the labeled amount of C17H17ClO6is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— Proceed as directed for Procedure for content uniformityin the test for Uniformity of dosage unitsunder Griseofulvin Tablets.
Loss on drying á731ñ— Dry about 100mg of finely ground Tablets,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 5.0%of its weight.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Griseofulvin.
Assay preparation— Weigh and finely powder not less than 20Tablets and proceed as directed for Assay preparationin the Assayunder Griseofulvin Capsules,beginning with “transfer an accurately weighed portion.”
Procedure— Proceed as directed for Procedurein the Assayunder Griseofulvin.Calculate the quantity,in mg,of griseofulvin (C17H17ClO6)in the portion of Tablets taken by the formula:
PC(rU/rS),
in which Cis the concentration,in mg per mL,of USP Griseofulvin RSin the Standard preparation,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 922
Phone Number:1-301-816-8335