U.S. PHARMACOPEIA

Search USP29  
Carbachol
Click to View Image
C6H15ClN2O2 182.65

Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,N-trimethyl-, chloride.
Choline chloride, carbamate [51-83-2].
» Carbachol contains not less than 99.0 percent and not more than 101.0 percent of C6H15ClN2O2, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
Identification—
A: To a solution of about 5 mg in 5 mL of water add 5 mL of ammonium reineckate solution (1 in 30), and shake vigorously for 1 minute: a red precipitate is formed, and it is soluble in acetone.
B: To 500 mg add 10 mL of alcoholic potassium hydroxide TS, and boil gently for 1 to 2 minutes: a white precipitate is formed, and an amine odor is perceptible when the mixture cools. Decant the supernatant, and add to the precipitate 3 mL of 3 N hydrochloric acid: effervescence is produced.
C: A solution (1 in 20) responds to the tests for Chloride 191.
D: To a solution of 100 mg in 1 mL of water add 3 mL of gold chloride solution (1 in 10): a precipitate of yellow crystals of the aurichloride is formed. The precipitate, upon recrystallization from about 5 mL of hot water, separates in glistening scale-like crystals which, after drying at 105 for 1 hour, melt between 183 and 185.
Melting range 741: between 200 and 204, with some decomposition.
Loss on drying 731 Dry about 1 g, accurately weighed, at 105 for 2 hours: it loses not more than 2.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Ordinary impurities 466
Test solution: a mixture of methanol and water (4:1).
Standard solution: a mixture of methanol and water (4:1).
Eluant: alcohol.
Visualization: 16.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 400 mg of Carbachol, accurately weighed, in a mixture of 10 mL of glacial acetic acid and 10 mL of mercuric acetate TS. Add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 18.27 mg of C6H15ClN2O2.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 368
Phone Number : 1-301-816-8330