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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.
Identification—
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: 16.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 1861
Phone Number : 1-301-816-8139