Griseofulvin Oral Suspension
» Griseofulvin Oral Suspension contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of griseofulvin (C17H17ClO6). It contains one or more suitable colors, diluents, flavors, preservatives, and wetting agents.
Packaging and storage— Preserve in tight containers.
Labeling— The label indicates that the griseofulvin contained is known as griseofulvin (microsize).
USP Reference standards 11
USP Griseofulvin RS Click to View Structure
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.
Uniformity of dosage units 905
for suspension packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 5.5 and 7.5.
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Griseofulvin.
Sodium chloride solution— Dissolve a suitable quantity of sodium chloride in water to obtain a solution containing about 0.1 g per mL.
Assay preparation— Transfer an accurately measured volume of Oral Suspension, freshly mixed and free from air bubbles, equivalent to about 125 mg of griseofulvin, to a glass-stoppered, 50-mL centrifuge tube. Add 20 mL of Sodium chloride solution and 20 mL of methylene chloride. Insert the stopper into the tube, and mix by rotating the tube for 10 minutes. Separate the phases by centrifugation, carefully remove the lower methylene chloride layer with a needle and syringe, and filter through methylene chloride-prerinsed anhydrous sodium sulfate into a 100-mL volumetric flask. Repeat the extraction with two additional 20-mL portions of methylene chloride, combining the extracts in the volumetric flask. Dilute with methylene chloride to volume, and mix. Transfer 5.0 mL of the resulting solution to a 50-mL volumetric flask, and evaporate on a steam bath under a stream of nitrogen to dryness. Transfer 4.0 mL of Mobile phase to the flask, swirl to dissolve the residue, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Griseofulvin. Calculate the quantity, in mg, of griseofulvin (C17H17ClO6) in each mL of the Oral Suspension taken by the formula:
(PC / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Griseofulvin RS in the Standard preparation; V is the volume, in mL, of Oral Suspension taken; and the other terms are as defined therein.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
USP35–NF30 Page 3379