C10H16ClNO 201.69

Benzenaminium, N-ethyl-3-hydroxy-N,N-dimethyl-, chloride.
Ethyl(m-hydroxyphenyl)dimethylammonium chloride [116-38-1].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Edrophonium Chloride RS.

Identification—

Melting range 741: between 165 and 170, with decomposition.

pH 791: between 4.0 and 5.0, in a solution (1 in 10).

Loss on drying 731— Dry it in a suitable vacuum drying tube, using phosphorus pentoxide as the desiccant, for 3 hours: it loses not more than 0.5% of its weight.

Residue on ignition 281: not more than 0.1%.

Heavy metals 231— Dissolve 1.0 g in 25 mL of water: the limit is 0.002%.

Limit of dimethylaminophenol— Dissolve about 500 mg, accurately weighed, in 5 mL of water in a separator. Add 5 mL of pH 8.0 phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions), and shake. Extract with five 20-mL portions of chloroform, pooling the extracts in a 100-mL volumetric flask, and add chloroform to volume. The absorbance of this solution, determined in a 1-cm cell at 252 nm, with a suitable spectrophotometer, is not more than that of a 1 in 200,000 solution of dimethylaminophenol in chloroform, similarly measured (0.1%).

Residual solvents 467: meets the requirements.

Assay— Transfer about 175 mg of Edrophonium Chloride, accurately weighed, to a suitable flask, and dissolve in about 20 mL of glacial acetic acid. Add 5 mL of mercuric acetate TS, then add 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 20.17 mg of C10H16ClNO.

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 780

Phone Number : 1-301-816-8251