C21H25NO·CH4O3S 403.54

8-Azabicyclo[3.2].1octane, 3-(diphenylmethoxy)-, endo-, methanesulfonate.

3-(Diphenylmethoxy)-1H,5H-tropane methanesulfonate [132-17-2].

Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Benztropine Mesylate RS.

Identification, Infrared Absorption 197K.

Melting range 741: between 141 and 148.

Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 5.0% of its weight.

Residue on ignition 281: not more than 0.1%.

Organic volatile impurities, Method I 467: meets the requirements.

Residual solvents 467: meets the requirements.

Assay— Transfer about 60 mg of Benztropine Mesylate, accurately weighed, to a 125-mL separator. Dissolve in 25 mL of water, add 5 mL of sodium carbonate TS, and extract with four 10-mL portions of chloroform. Wash the combined chloroform extracts with about 10 mL of water, and extract the wash solution with 5 mL of chloroform. Filter the combined chloroform extracts through a tightly packed pledget of cotton, and wash the cotton with about 5 mL of chloroform. Add methyl red TS, and titrate the chloroform solution with 0.01 N perchloric acid in dioxane VS. Perform a blank determination, and make any necessary correction. Each mL of 0.01 N perchloric acid is equivalent to 4.035 mg of C21H25NO·CH4O3S.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 259

Phone Number : 1-301-816-8330