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Neostigmine Bromide
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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 98.0 percent and not more than 102.0 percent of C12H19BrN2O2, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
Identification—
B: A solution (1 in 50) responds to the tests for Bromide 191.
Melting range 741: between 171 and 176, with decomposition.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 2.0% of its weight.
Residue on ignition 281: not more than 0.15%.
Sulfate— Dissolve 250 mg in 10 mL of water, and add 1 mL of 3 N hydrochloric acid and 1 mL of barium chloride TS: no turbidity is produced immediately.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 750 mg of Neostigmine Bromide, accurately weighed, in a mixture of 70 mL of glacial acetic acid and 20 mL of mercuric acetate TS, add 4 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 30.32 mg of C12H19BrN2O2.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1516
Phone Number : 1-301-816-8330