Edrophonium Chloride
(ed'' roe foe' nee um klor' ide).
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C10H16ClNO 201.69

Benzenaminium, N-ethyl-3-hydroxy-N,N-dimethyl-, chloride.
Ethyl(m-hydroxyphenyl)dimethylammonium chloride [116-38-1].
» Edrophonium Chloride contains not less than 98.0 percent and not more than 100.5 percent of C10H16ClNO, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11
USP Edrophonium Chloride RS Click to View Structure
Identification—
B: Ultraviolet Absorption 197U
Solution: 50 µg per mL.
Medium: 0.1 N hydrochloric acid.
Absorptivities at 273 nm, calculated on the dried basis, do not differ by more than 2.0%.
C: To 10 mL of a solution (1 in 10) add 1 drop of ferric chloride TS: a violet-blue color is produced.
D: It responds to the tests for Chloride 191.
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%).
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.
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USP35–NF30 Page 3009
Pharmacopeial Forum: Volume No. 29(5) Page 1475