U.S. PHARMACOPEIA

Search USP29  
Acetylcholine Chloride
Click to View Image
C7H16ClNO2 181.66

Ethanaminium, 2-(acetyloxy)-N,N,N-trimethyl-, chloride.
Choline acetate (ester) chloride [60-31-1].
» Acetylcholine Chloride contains not less than 98.0 percent and not more than 102.0 percent of C7H16 ClNO2, calculated on the dried basis.
Packaging and storage— Preserve in tight container, and store at controlled room temperature.
Identification—
B: To 5 mL of a solution (1 in 10) add 5 mL of silver nitrate TS: a white, curdy precipitate, which is soluble in ammonium hydroxide but insoluble in nitric acid, is formed.
Melting range, Class I 741: between 149 and 152.
Acidity— Dissolve 100 mg in 10 mL of recently boiled water, and add at once 1 drop of bromothymol blue TS: not more than 0.50 mL of 0.010 N sodium hydroxide is required in order to produce a color change.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.2%.
Organic volatile impurities, Method I 467: meets the requirements.
Chloride content— Transfer about 280 mg, accurately weighed, to a porcelain casserole, and add 140 mL of water and 1 mL of dichlorofluorescein TS. Mix, and titrate with 0.1 N silver nitrate VS until the silver chloride flocculates and the mixture acquires a faint pink color. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of Cl. Not less than 19.3% and not more than 19.8% of Cl, calculated on the dried basis, is found.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Weigh accurately about 400 mg of Acetylcholine Chloride, and dissolve in 15 mL of water in a glass-stoppered conical flask. Add 40.0 mL of 0.1 N sodium hydroxide VS, and heat on a steam bath for 30 minutes. Insert the stopper, allow to cool, add phenolphthalein TS, and titrate the excess alkali with 0.1 N sulfuric acid VS. Perform a blank determination (see Residual Titrations under Titrimetry 541). Each mL of 0.1 N sodium hydroxide is equivalent to 18.17 mg of C7H16ClNO2.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 50
Pharmacopeial Forum : Volume No. 27(3) Page 2502
Phone Number : 1-301-816-8330