C17H20N2O2 284.35

Benzeneacetamide, N-ethyl--(hydroxymethyl)-N-(4-pyridinylmethyl)-, (±)-.
(±)-N-Ethyl-2-phenyl-N-(4-pyridylmethyl)hydracrylamide [1508-75-4].

Packaging and storage— Preserve in tight, light-resistant containers.

USP Reference standards 11— USP Tropicamide RS.

Identification—

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.

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.

Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 2223

Phone Number : 1-301-816-8320