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 98.0percent and not more than 100.5percent of C18H22N2·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Dissolve 500mg in 10mLof a mixture of 3volumes of alcohol and 2volumes of water,warming if necessary.Cool the solution in an ice bath,add 1mLof 1Nsodium hydroxide and 20mLof water,stir,and filter:the precipitate of the base so obtained,washed with water and dried in vacuum at 60
for 2hours,melts between 106and 109.
for 2hours,melts between 106and 109.
C:
It responds to the tests for Chloride á191ñ.
pHá791ñ:
between 4.5and 5.5,determined potentiometrically in a 1in 50solution,the solvent being a mixture of 2volumes of alcohol and 3volumes of water.
Loss on drying á731ñ—
Dry it at 120for 3hours:it loses not more than 1.0%of its weight.
for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of chloroform,methanol,and ammonium hydroxide (80:20:1).
Visualization:
2.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Assay—
Transfer to a beaker about 400mg of Cyclizine Hydrochloride,accurately weighed,and dissolve in 80mLof glacial acetic acid.Add 10mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 15.14mg of C18H22N2·HCl.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 555
Phone Number:1-301-816-8251