Cyclizine Hydrochloride
C18H22N2·HCl 302.84

Piperazine, 1-(diphenylmethyl)-4-methyl-, monohydrochloride.
1-(Diphenylmethyl)-4-methylpiperazine monohydrochloride [303-25-3].
» Cyclizine Hydrochloride contains not less than 98.0 percent and not more than 100.5 percent of C18H22N2·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
B: Dissolve 500 mg in 10 mL of a mixture of 3 volumes of alcohol and 2 volumes of water, warming if necessary. Cool the solution in an ice bath, add 1 mL of 1 N sodium hydroxide and 20 mL of water, stir, and filter: the precipitate of the base so obtained, washed with water and dried in vacuum at 60 for 2 hours, melts between 106 and 109.
C: It responds to the tests for Chloride 191.
pH 791: between 4.5 and 5.5, determined potentiometrically in a 1 in 50 solution, the solvent being a mixture of 2 volumes of alcohol and 3 volumes of water.
Loss on drying 731 Dry it at 120 for 3 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.2%.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of chloroform, methanol, and ammonium hydroxide (80:20:1).
Visualization: 2.
Assay— Transfer to a beaker about 400 mg of Cyclizine Hydrochloride, accurately weighed, and dissolve in 80 mL of glacial acetic acid. Add 10 mL of mercuric acetate TS, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 15.14 mg of C18H22N2·HCl.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2038
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.