Dicyclomine Hydrochloride
;)
[Bicyclohexyl]-1-carboxylic acid,2-(diethylamino)ethyl ester,hydrochloride.
2-(Diethylamino)ethyl[bicyclohexyl]-1-carboxylate hydrochloride [67-92-5].
»Dicyclomine Hydrochloride contains not less than 99.0percent and not more than 102.0percent of C19H35NO2·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Mix about 5mLof a 1in 500solution of it with about 2mLof 2Nnitric acid,and add about 2mLof silver nitrate TS:a white precipitate is formed which is insoluble in nitric acid but soluble in a slight excess of 6Nammonium hydroxide.
pHá791ñ:
between 5.0and 5.5,in a solution (1in 100).
Loss on drying á731ñ—
Dry it at 105
for 4hours:it loses not more than 1.0%of its weight.
for 4hours:it loses not more than 1.0%of its weight.
Readily carbonizable substances á271ñ—
Dissolve 500mg in 5mLof sulfuric acid TS:the solution has no more color than Matching Fluid D.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 600mg of Dicyclomine Hydrochloride,accurately weighed,in 70mLof glacial acetic acid,add 10mLof mercuric acetate TSand 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 34.60mg of C19H35NO2·HCl.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 629
Pharmacopeial Forum:Volume No.29(5)Page 1458
Phone Number:1-301-816-8251