Cyclizine Hydrochloride Tablets, chemical structure, molecular formula, Reference Standards

Cyclizine Hydrochloride Tablets

»Cyclizine Hydrochloride Tablets contain not less than 93.0percent and not more than 107.0percent of the labeled amount of C18H22N2·HCl.

Packaging and storage— Preserve in tight,light-resistant containers.

USP Reference standards á11ñ— USP Cyclizine Hydrochloride RS.

Identification—

A: Shake a quantity of finely powdered Tablets,equivalent to about 500mg of cyclizine hydrochloride,with 25mLof water for 5minutes,and filter the mixture.Cool the filtrate in an ice bath,add a slight excess of 1Nsodium hydroxide,and stir well:the precipitate so obtained responds to Identificationtest Bunder Cyclizine Hydrochloride.

B: Tablets meet the requirements under Identification—Organic Nitrogenous Bases á181ñ.

Dissolution,Procedure for a Pooled Sample á711ñ—

Medium: water;900mL.

Apparatus 2: 50rpm.

Time: 45minutes.

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 45minutes.

Uniformity of dosage units á905ñ: meet the requirements.

Assay— Proceed with Tablets as directed under Salts of Organic Nitrogenous Bases á501ñ,diluting the Standard Preparationand the Assay Preparation,respectively,with an equal volume of dilute sulfuric acid (1in 100),and determining the absorbance at the wavelength of maximum absorbance at about 264nm.Calculate the quantity,in mg,of C18H22N2·HCl in the portion of Tablets taken by the formula:

50C(AU/AS),

in which Cis the concentration,in mg per mL,of USP Cyclizine Hydrochloride RSin the Standard Preparation.

Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 555

Pharmacopeial Forum:Volume No.30(1)Page 91

Phone Number:1-301-816-8251