Dicyclomine Hydrochloride
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345.95[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 99.0 percent and not more than 102.0 percent of C19H35NO2·HCl, calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
USP Reference standards 
11
—
11—
USP Dicyclomine Hydrochloride RS 
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Identification—
B:
Mix about 5 mL of a 1 in 500 solution of it with about 2 mL of 2 N nitric acid, and add about 2 mL of silver nitrate TS: a white precipitate is formed which is insoluble in nitric acid but soluble in a slight excess of 6 N ammonium hydroxide.
Melting range, Class I 741:
between 169
and 174.
741:
between 169 and 174.
pH 791:
between 5.0 and 5.5, in a solution (1 in 100).
791:
between 5.0 and 5.5, in a solution (1 in 100).
Loss on drying 731—
Dry it at 105 for 4 hours: it loses not more than 1.0% of its weight.
731—
Dry it at 105 for 4 hours: it loses not more than 1.0% of its weight.
Readily carbonizable substances 271—
Dissolve 500 mg in 5 mL of sulfuric acid: the solution has no more color than Matching Fluid D.
271—
Dissolve 500 mg in 5 mL of sulfuric acid: the solution has no more color than Matching Fluid D.
Assay—
Dissolve about 600 mg of Dicyclomine Hydrochloride, accurately weighed, in 70 mL of glacial acetic acid, add 10 mL of mercuric acetate TS and 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 34.60 mg of C19H35NO2·HCl.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Elena Gonikberg, Ph.D.
Principal Scientific Liaison 1-301-816-8251 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2886
Pharmacopeial Forum: Volume No. 34(5) Page 1152