Pseudoephedrine Sulfate
(C10H15NO)2·H2SO4
428.54
Benzenemethanol,a-[1-(methylamino)ethyl]-,[S-(R*,R*)]-,sulfate (2:1)(salt).
(+)-Pseudoephedrine sulfate (2:1)(salt) [7460-12-0].
»Pseudoephedrine Sulfate contains not less than 98.0percent and not more than 100.5percent of (C10H15NO)2·H2SO4,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
500µg per mL.
Medium:
water.
Absorptivities at 257nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Asolution of it responds to the test for Sulfate á191ñ.
Melting range,Class Iá741ñ:
between 174
and 179,but the range between beginning and end of melting does not exceed 2.
and 179,but the range between beginning and end of melting does not exceed 2.
Specific rotation á781Sñ:
between +56.0and +59.0.
and +59.0.
Test solution:
50mg per mL,in water.
pHá791ñ:
between 5.0and 6.5in a solution (1in 20).
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 2.0%of its weight.
for 2hours:it loses not more than 2.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Chloride á221ñ—
A200-mg portion shows no more chloride than corresponds to 0.4mLof 0.02Nhydrochloric acid (0.14%).
Heavy metals—
Treat a solution of 1.0g in 20mLof dilute alcohol (1in 2)with 5mLof sodium hydroxide solution (1in 20)and 5drops of sodium sulfide TS:the color developed is not darker than that of a blank determination performed simultaneously,containing 10ppm of standard lead solution (see Heavy Metals á231ñ).
Ordinary impurities á466ñ—
Test solution:
alcohol.
Standard solution:
alcohol.
Eluant:
a mixture of alcohol,glacial acetic acid,and water (10:3:1).
Visualization:
16.
Assay—
Dissolve about 150mg of Pseudoephedrine Sulfate,accurately weighed,in 50mLof glacial acetic acid.Titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 42.85mg of (C10H15NO)2·H2SO4.
Auxiliary Information—
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1675
Phone Number:1-301-816-8143