Pseudoephedrine Hydrochloride
;)
Benzenemethanol,a-[1-(methylamino)ethyl]-,[S-(R*,R*)]-,hydrochloride.
(+)-Pseudoephedrine hydrochloride [345-78-8].
»Pseudoephedrine Hydrochloride contains not less than 98.0percent and not more than 100.5percent of C10H15NO·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Asolution responds to the tests for Chloride á191ñ.
Melting range,Class Iá741ñ:
between 182
and 186,but the range between beginning and end of melting does not exceed 2.
and 186,but the range between beginning and end of melting does not exceed 2.
Specific rotation á781Sñ:
between +61.0and +62.5.
and +62.5.
Test solution:
50mg per mL,in water.
pHá791ñ:
between 4.6and 6.0,in a solution (1in 20).
Loss on drying á731ñ—
Dry it at 105for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
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 2hours 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 30minutes.
Organic volatile impurities,Method Vá467ñ:
meets the requirements,except to maintain the injection port temperature at 70,instead of at 140.
,instead of at 140.
Assay—
Dissolve about 400mg of Pseudoephedrine Hydrochloride,accurately weighed,in a mixture of 50mLof glacial acetic acid and 10mLof mercuric acetate TS,add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 20.17mg of C10H15NO·HCl.
Auxiliary Information—
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1670
Phone Number:1-301-816-8143