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.
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.
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.
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 C
7H
16ClNO
2.
Auxiliary Information
Staff Liaison :
Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29NF24 Page 50
Pharmacopeial Forum : Volume No. 27(3) Page 2502
Phone Number : 1-301-816-8330