Packaging and storage—
Preserve in tight, light-resistant containers.
Identification—
B:
A solution responds to the tests for
Chloride 
191
.
Specific rotation 781S:
between +61.0
and +62.5
.
Test solution:
50 mg per mL, in water.
pH 791:
between 4.6 and 6.0, in a solution (1 in 20).
Ordinary impurities 466—
Test solution:
alcohol.
Standard solution:
alcohol.
Eluant:
a mixture of alcohol, glacial acetic acid, and water (10:3:1).
Visualization—
Dry the plate overnight in a hood or for 2 hours with a current from a hot air dryer. In a pre-equilibrated closed chamber, on the bottom of which there are iodine crystals, expose the plate to iodine vapors for not less than 30 minutes.
Organic volatile impurities, Method V 467:
meets the requirements, except to maintain the injection port temperature at 70
, instead of at 140
.
Assay—
Dissolve about 400 mg of Pseudoephedrine Hydrochloride, accurately weighed, in a mixture of 50 mL of glacial acetic acid and 10 mL of
mercuric acetate TS, add 1 drop of
crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 20.17 mg of C
10H
15NO·HCl.
;)
-[1-(methylamino)ethyl]-, [S-(R*,R*)]-, hydrochloride.