Neostigmine Bromide
;)
Benzenaminium,3-[[(dimethylamino)carbonyl]oxy]-N,N,N-trimethyl-,bromide.
(m-Hydroxyphenyl)trimethylammonium bromide dimethylcarbamate [114-80-7].
»Neostigmine Bromide contains not less than 98.0percent and not more than 102.0percent of C12H19BrN2O2,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Asolution (1in 50)responds to the tests for Bromide á191ñ.
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 2.0%of its weight.
for 3hours:it loses not more than 2.0%of its weight.
Residue on ignition á281ñ:
not more than 0.15%.
Sulfate—
Dissolve 250mg in 10mLof water,and add 1mLof 3Nhydrochloric acid and 1mLof barium chloride TS:no turbidity is produced immediately.
Assay—
Dissolve about 750mg of Neostigmine Bromide,accurately weighed,in a mixture of 70mLof glacial acetic acid and 20mLof mercuric acetate TS,add 4drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 30.32mg of C12H19BrN2O2.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1364
Phone Number:1-301-816-8330