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Cyclizine Hydrochloride Tablets
» Cyclizine Hydrochloride Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of C18H22N2·HCl.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
A: Shake a quantity of finely powdered Tablets, equivalent to about 500 mg of cyclizine hydrochloride, with 25 mL of water for 5 minutes, and filter the mixture. Cool the filtrate in an ice bath, add a slight excess of 1 N sodium hydroxide, and stir well: the precipitate so obtained responds to Identification test B under Cyclizine Hydrochloride.
B: Tablets meet the requirements under Identification—Organic Nitrogenous Bases 181.
Dissolution, Procedure for a Pooled Sample 711—
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C18H22N2·HCl dissolved, employing the procedure set forth in the Assay, making any necessary modifications.
Tolerances— Not less than 75% (Q) of the labeled amount of C18H22N2·HCl is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Proceed with Tablets as directed under Salts of Organic Nitrogenous Bases 501, diluting the Standard Preparation and the Assay Preparation, respectively, with an equal volume of dilute sulfuric acid (1 in 100), and determining the absorbance at the wavelength of maximum absorbance at about 264 nm. Calculate the quantity, in mg, of C18H22N2·HCl in the portion of Tablets taken by the formula:
50C(AU / AS),
in which C is the concentration, in mg per mL, of USP Cyclizine Hydrochloride RS in the Standard Preparation.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 605
Pharmacopeial Forum : Volume No. 30(1) Page 91
Phone Number : 1-301-816-8251