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 á11ñ— USP Edrophonium Chloride RS.

Identification—

Melting range á741ñ: between 165and 170,with decomposition.

pHá791ñ: between 4.0and 5.0,in a solution (1in 10).

Loss on drying á731ñ— Dry it in a suitable vacuum drying tube,using phosphorus pentoxide as the desiccant,for 3hours:it loses not more than 0.5%of its weight.

Residue on ignition á281ñ: not more than 0.1%.

Heavy metals á231ñ— Dissolve 1.0g in 25mLof water:the limit is 0.002%.

Limit of dimethylaminophenol— Dissolve about 500mg,accurately weighed,in 5mLof water in a separator.Add 5mLof pH8.0phosphate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions),and shake.Extract with five 20-mLportions of chloroform,pooling the extracts in a 100-mLvolumetric flask,and add chloroform to volume.The absorbance of this solution,determined in a 1-cm cell at 252nm,with a suitable spectrophotometer,is not more than that of a 1in 200,000solution of dimethylaminophenol in chloroform,similarly measured (0.1%).

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

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 715

Phone Number:1-301-816-8251