Benztropine Mesylate
;)
8-Azabicyclo[3.2].1octane,3-(diphenylmethoxy)-,endo-,methanesulfonate.
3a-(Diphenylmethoxy)-1aH,5aH-tropane methanesulfonate [132-17-2].
»Benztropine Mesylate contains not less than 98.0percent and not more than 100.5percent of C21H25NO·CH4O3S,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 5.0%of its weight.
for 2hours:it loses not more than 5.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer about 60mg of Benztropine Mesylate,accurately weighed,to a 125-mLseparator.Dissolve in 25mLof water,add 5mLof sodium carbonate TS,and extract with four 10-mLportions of chloroform.Wash the combined chloroform extracts with about 10mLof water,and extract the wash solution with 5mLof chloroform.Filter the combined chloroform extracts through a tightly packed pledget of cotton,and wash the cotton with about 5mLof chloroform.Add methyl red TS,and titrate the chloroform solution with 0.01Nperchloric acid in dioxane VS.Perform a blank determination,and make any necessary correction.Each mLof 0.01Nperchloric acid is equivalent to 4.035mg of C21H25NO·CH4O3S.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 237
Pharmacopeial Forum:Volume No.29(6)Page 1848
Phone Number:1-301-816-8165