Neostigmine Bromide
Click to View Image
C12H19BrN2O2 303.20

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.
Melting range á741ñ: between 171and 176,with decomposition.
Loss on drying á731ñ Dry it at 105for 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