Packaging and storage—
Preserve in tight containers.
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
.
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.
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.
Organic volatile impurities, Method I 467:
meets the requirements.
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 C
9H
13BrN
2O
2.
Auxiliary Information—
Staff Liaison :
Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1868
Pharmacopeial Forum : Volume No. 29(6) Page 1977
Phone Number : 1-301-816-8330
;)
