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C17H20N2O2 284.35

Benzeneacetamide, N-ethyl--(hydroxymethyl)-N-(4-pyridinylmethyl)-, (±)-.
(±)-N-Ethyl-2-phenyl-N-(4-pyridylmethyl)hydracrylamide [1508-75-4].
» Tropicamide contains not less than 99.0 percent and not more than 101.0 percent of C17H20N2O2, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
B: Ultraviolet Absorption 197U
Solution: 25 µg per mL.
Medium: 3 N hydrochloric acid.
Melting range, Class I 741: between 96 and 100.
Loss on drying 731 Dry about 500 mg, accurately weighed, in vacuum over phosphorus pentoxide at 80 for 4 hours: it loses not more than 0.5% of its weight.
Heavy metals, Method II 231: 0.002%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 750 mg of Tropicamide, accurately weighed, in 80 mL of glacial acetic acid, add 4 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 28.44 mg of C17H20N2O2.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 2223
Phone Number : 1-301-816-8320