Pyridostigmine Bromide
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C9H13BrN2O2 261.12

Pyridinium, 3-[[(dimethylamino)carbonyl]oxy]-1-methyl-, bromide.
3-Hydroxy-1-methylpyridinium bromide dimethylcarbamate [101-26-8].
» Pyridostigmine Bromide contains not less than 98.5 percent and not more than 100.5 percent of C9H13BrN2O2, calculated on the dried basis.
Packaging and storage— Preserve in tight containers.
Solution: 35 µg per mL.
Medium: 0.1 N hydrochloric acid.
Absorptivities at 269 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: To about 100 mg in a test tube add 0.6 mL of 1 N sodium hydroxide: an orange color develops. When the mixture is heated, the color changes to yellow, and a strip of moistened red litmus paper held over the top of the test tube turns blue.
D: A solution (1 in 50) responds to tests for Bromide 191.
Melting range 741: between 154 and 157, the test specimen having been previously dried.
Loss on drying 731 Dry it in a suitable vacuum drying tube, using phosphorus pentoxide as the desiccant, at 100 for 4 hours: it loses not more than 2.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of methanol and water (1:1); the thin-layer chromatographic plate coating material is cellulose with a fluorescent indicator.
Visualization: 1.
Assay— Dissolve about 850 mg of Pyridostigmine Bromide, accurately weighed, in 80 mL of glacial acetic acid. Add 25 mL of mercuric acetate TS and 2 drops of quinaldine red TS, and titrate with 0.1 N perchloric acid in dioxane VS to a colorless endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 26.11 mg of C9H13BrN2O2.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3449
Pharmacopeial Forum: Volume No. 29(6) Page 1977
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.