Packaging and storage—
Preserve in well-closed containers.
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.
pH 
791
:
between 5.0 and 5.5, in a solution (1 in 100).
Organic volatile impurities, Method I 467:
meets the requirements.
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 C
19H
35NO
2·HCl.
Auxiliary Information—
Staff Liaison :
Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 686
Pharmacopeial Forum : Volume No. 29(5) Page 1458
Phone Number : 1-301-816-8251
;)
for 4 hours: it loses not more than 1.0% of its weight.