Pseudoephedrine Hydrochloride
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C10H15NO·HCl 201.69

Benzenemethanol, -[1-(methylamino)ethyl]-, [S-(R*,R*)]-, hydrochloride.
(+)-Pseudoephedrine hydrochloride [345-78-8].
» Pseudoephedrine Hydrochloride contains not less than 98.0 percent and not more than 100.5 percent of C10H15NO·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
B: A solution responds to the tests for Chloride 191.
Melting range, Class I 741: between 182 and 186, but the range between beginning and end of melting does not exceed 2.
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).
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Change to read:
Ordinary impurities 466
Test solution: alcohol.
Standard solution: alcohol.
Eluant: A mixture of isopropyl alcohol, ammonium hydroxide, and chloroform (80:15:5).USP32
Visualization— 1, followed by 4.USP32
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 C10H15NO·HCl.
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 3438
Pharmacopeial Forum: Volume No. 34(2) Page 298
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.