Edrophonium Chloride
201.69Benzenaminium, 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.
Identification—
B:
Ultraviolet Absorption 
197U
—
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.
191.
and 170
pH 791:
between 4.0 and 5.0, in a solution (1 in 10).
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.
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%.
281:
not more than 0.1%.
Heavy metals 231—
Dissolve 1.0 g in 25 mL of water: the limit is 0.002%.
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Elena Gonikberg, Ph.D.
Senior Scientist 1-301-816-8251 |
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 2230
Pharmacopeial Forum: Volume No. 29(5) Page 1475