USP Monographs: Eucatropine Hydrochloride

Eucatropine Hydrochloride

C17H25NO3·HCl

327.85

Benzeneacetic acid,

-hydroxy-, 1,2,2,6-tetramethyl-4-piperidinyl ester hydrochloride.
1,2,2,6-Tetramethyl-4-piperidyl mandelate hydrochloride

[536-93-6].

» Eucatropine Hydrochloride contains not less than 99.0 percent and not more than 100.5 percent of C17H25NO3·HCl, calculated on the dried basis.

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

Identification—

A: Dissolve about 50 mg in 5 mL of water, render the solution alkaline with 6 N ammonium hydroxide, and extract with two 10-mL portions of ether. Evaporate the ether on a steam bath, and recrystallize the residue from solvent hexane: the eucatropine base so obtained melts between 111

and 114

B: A solution of it responds to the tests for Chloride

191

Melting range

741

: between 183

and 186

Loss on drying

731

— Dry it over silica gel for 4 hours: it loses not more than 0.5% of its weight.

Residue on ignition

281

: not more than 0.1%.

Organic volatile impurities, Method I

467

: meets the requirements.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay— Weigh accurately about 500 mg of Eucatropine Hydrochloride, and dissolve it in 10 mL of water. Saturate the solution with sodium chloride. Render it alkaline with 6 N ammonium hydroxide, and extract the base completely with successive 15-mL portions of ether. Wash the combined ether extracts with 10 mL of water, and extract the water washing with 10 mL of ether. To the combined ether solutions add 25.0 mL of 0.1 N sulfuric acid VS, and stir. Heat gently until the ether is expelled, cool, add methyl red TS, and titrate the excess acid with 0.1 N sodium hydroxide VS. Each mL of 0.1 N sulfuric acid is equivalent to 32.79 mg of C17H25NO3·HCl.

Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate

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

USP29–NF24 Page 880

Phone Number : 1-301-816-8320