Carbachol
;)
Ethanaminium,2-[(aminocarbonyl)oxy]-N,N,N-trimethyl-,chloride.
Choline chloride,carbamate [51-83-2].
»Carbachol contains not less than 99.0percent and not more than 101.0percent of C6H15ClN2O2,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
To a solution of about 5mg in 5mLof water add 5mLof ammonium reineckate solution (1in 30),and shake vigorously for 1minute:a red precipitate is formed,and it is soluble in acetone.
B:
To 500mg add 10mLof alcoholic potassium hydroxide TS,and boil gently for 1to 2minutes:a white precipitate is formed,and an amine odor is perceptible when the mixture cools.Decant the supernatant,and add to the precipitate 3mLof 3Nhydrochloric acid:effervescence is produced.
C:
Asolution (1in 20)responds to the tests for Chloride á191ñ.
D:
To a solution of 100mg in 1mLof water add 3mLof gold chloride solution (1in 10):a precipitate of yellow crystals of the aurichloride is formed.The precipitate,upon recrystallization from about 5mLof hot water,separates in glistening scale-like crystals which,after drying at 105
for 1hour,melt between 183and 185.
for 1hour,melt between 183and 185.
Loss on drying á731ñ—
Dry about 1g,accurately weighed,at 105for 2hours:it loses not more than 2.0%of its weight.
for 2hours:it loses not more than 2.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
a mixture of methanol and water (4:1).
Standard solution:
a mixture of methanol and water (4:1).
Eluant:
alcohol.
Visualization:
16.
Assay—
Dissolve about 400mg of Carbachol,accurately weighed,in a mixture of 10mLof glacial acetic acid and 10mLof mercuric acetate TS.Add 2drops 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 18.27mg of C6H15ClN2O2.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 340
Phone Number:1-301-816-8165