Benztropine Mesylate
(benz' troe peen mes' i late).
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C21H25NO·CH4O3S 403.54

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

3-(Diphenylmethoxy)-1h,5h-tropane methanesulfonate [132-17-2].
» Benztropine Mesylate contains not less than 98.0 percent and not more than 100.5 percent of C21H25NO·CH4O3S, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Benztropine Mesylate RS Click to View Structure
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%.
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.
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Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 2330
Pharmacopeial Forum: Volume No. 29(6) Page 1848