Pyridostigmine Bromide
;)
Pyridinium,3-[[(dimethylamino)carbonyl]oxy]-1-methyl-,bromide.
3-Hydroxy-1-methylpyridinium bromide dimethylcarbamate [101-26-8].
»Pyridostigmine Bromide contains not less than 98.5percent and not more than 100.5percent of C9H13BrN2O2,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
35µg per mL.
Medium:
0.1Nhydrochloric acid.
Absorptivities at 269nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
To about 100mg in a test tube add 0.6mLof 1Nsodium 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:
Asolution (1in 50)responds to tests for Bromide á191ñ.
Loss on drying á731ñ—
Dry it in a suitable vacuum drying tube,using phosphorus pentoxide as the desiccant,at 100
for 4hours:it loses not more than 2.0%of its weight.
for 4hours:it loses not more than 2.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
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 Iá467ñ:
meets the requirements.
Assay—
Dissolve about 850mg of Pyridostigmine Bromide,accurately weighed,in 80mLof glacial acetic acid.Add 25mLof mercuric acetate TSand 2drops of quinaldine red TS,and titrate with 0.1Nperchloric acid in dioxane VSto a colorless endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 26.11mg of C9H13BrN2O2.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1681
Pharmacopeial Forum:Volume No.29(6)Page 1977
Phone Number:1-301-816-8330