Tropicamide
Benzeneacetamide,N-ethyl-a-(hydroxymethyl)-N-(4-pyridinylmethyl)-,(±)-. (±)-N-Ethyl-2-phenyl-N-(4-pyridylmethyl)hydracrylamide [1508-75-4]. »Tropicamide contains not less than 99.0percent and not more than 101.0percent of C17H20N2O2,calculated on the dried basis.
Packaging and storage
Preserve in tight,light-resistant containers.
Identification
A:
Infrared Absorption á197Kñ.
Melting range,Class Iá741ñ:
between 96and 100.
Loss on drying á731ñ
Dry about 500mg,accurately weighed,in vacuum over phosphorus pentoxide at 80for 4hours:it loses not more than 0.5%of its weight.
Heavy metals,Method IIá231ñ:
0.002%.
Assay
Dissolve about 750mg of Tropicamide,accurately weighed,in 80mLof glacial acetic acid,add 4drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 28.44mg of C17H20N2O2.
Auxiliary Information
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28NF23Page 1998
Phone Number:1-301-816-8389
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