Griseofulvin Oral Suspension
»Griseofulvin Oral Suspension contains not less than 90.0percent and not more than 115.0percent 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).
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.
Uniformity of dosage units á905ñ—
FOR SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 5.5and 7.5.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Griseofulvin.
Sodium chloride solution— Dissolve a suitable quantity of sodium chloride in water to obtain a solution containing about 0.1g per mL.
Assay preparation— Transfer an accurately measured volume of Oral Suspension,freshly mixed and free from air bubbles,equivalent to about 125mg of griseofulvin,to a glass-stoppered,50-mLcentrifuge tube.Add 20mLof Sodium chloride solutionand 20mLof methylene chloride.Insert the stopper into the tube,and mix by rotating the tube for 10minutes.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-mLvolumetric flask.Repeat the extraction with two additional 20-mLportions of methylene chloride,combining the extracts in the volumetric flask.Dilute with methylene chloride to volume,and mix.Transfer 5.0mLof the resulting solution to a 50-mLvolumetric flask,and evaporate on a steam bath under a stream of nitrogen to dryness.Transfer 4.0mLof Mobile phaseto the flask,swirl to dissolve the residue,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Griseofulvin.Calculate the quantity,in mg,of griseofulvin (C17H17ClO6)in each mLof the Oral Suspension taken by the formula:
(PC/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Griseofulvin RSin the Standard preparation;Vis the volume,in mL,of Oral Suspension taken;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 921
Phone Number:1-301-816-8335
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