Pyridostigmine Bromide
(pir id'' oh stig' meen broe' mide).
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261.12Pyridinium, 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.
USP Reference standards 
11
—
11—
USP Pyridostigmine Bromide RS 
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Identification—
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.
191.
Melting range 741:
between 154
and 157, the test specimen having been previously dried.
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.
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%.
281:
not more than 0.1%.
Ordinary impurities 466—
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 | Hariram Ramanathan, M.S.
Associate Scientific Liaison 1-301-816-8313 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4489
Pharmacopeial Forum: Volume No. 29(6) Page 1977