Pseudoephedrine Sulfate
(C10H15NO)2·H2SO4 428.54

Benzenemethanol, -[1-(methylamino)ethyl]-, [S-(R*,R*)]-, sulfate (2:1) (salt).
(+)-Pseudoephedrine sulfate (2:1) (salt) [7460-12-0].
» Pseudoephedrine Sulfate contains not less than 98.0 percent and not more than 100.5 percent of (C10H15NO)2·H2SO4, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Solution: 500 µg per mL.
Medium: water.
Absorptivities at 257 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: A solution of it responds to the test for Sulfate 191.
Melting range, Class I 741: between 174 and 179, but the range between beginning and end of melting does not exceed 2.
Specific rotation 781S: between +56.0 and +59.0.
Test solution: 50 mg per mL, in water.
pH 791: between 5.0 and 6.5 in a solution (1 in 20).
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 2.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Chloride 221 A 200-mg portion shows no more chloride than corresponds to 0.4 mL of 0.02 N hydrochloric acid (0.14%).
Heavy metals— Treat a solution of 1.0 g in 20 mL of dilute alcohol (1 in 2) with 5 mL of sodium hydroxide solution (1 in 20) and 5 drops of sodium sulfide TS: the color developed is not darker than that of a blank determination performed simultaneously, containing 10 ppm of standard lead solution (see Heavy Metals 231).
Ordinary impurities 466
Test solution: alcohol.
Standard solution: alcohol.
Eluant: a mixture of alcohol, glacial acetic acid, and water (10:3:1).
Visualization: Expose the plate for 24 hours to iodine vapors in a pre-equilibrated closed chamber, on the bottom of which there are iodine crystals.
Assay— Dissolve about 150 mg of Pseudoephedrine Sulfate, accurately weighed, in 50 mL of glacial acetic acid. Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 42.85 mg of (C10H15NO)2·H2SO4.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3442
Pharmacopeial Forum: Volume No. 32(1) Page 135