Packaging and storage
Preserve in well-closed, light-resistant containers.
Identification
B:
To 5 mL of a solution (1 in 1000) add 5 mL of sodium carbonate solution (1 in 100), 0.5 mL of
bromophenol blue TS, and 10 mL of chloroform, and shake for several minutes: the chloroform layer becomes an intense blue in color.
C:
A solution (1 in 1000) responds to the tests for
Iodide
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.
Loss on drying
731
Dry it in vacuum at 60
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for 2 hours: it loses not more than 1.0% of its weight.
Heavy metals, Method II
231
:
0.002%.
Ordinary impurities
466
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of methanol, glacial acetic acid, and water (8:1:1).
Visualization:
2.
Organic volatile impurities, Method V
467
:
meets the requirements.
Solvent
Use dimethyl sulfoxide.
Assay
Dissolve about 750 mg of Isopropamide Iodide, previously dried and accurately weighed, in 60 mL of glacial acetic acid, add 15 mL of
mercuric acetate TS and 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 48.04 mg of C
23H
33IN
2O.