Pseudoephedrine Sulfate
(C10H15NO)2·H2SO4
428.54
428.54Benzenemethanol,
-[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
.
191.
Melting range, Class I 741:
between 174
and 179, but the range between beginning and end of melting does not exceed 2.
741:
between 174 and 179, but the range between beginning and end of melting does not exceed 2.
pH 791:
between 5.0 and 6.5 in a solution (1 in 20).
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.
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%.
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%).
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).
231).
Ordinary impurities 466—
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.
Scientist 1-301-816-8139 |
(MDCCA05) Monograph Development-Cough Cold and Analgesics |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 3442
Pharmacopeial Forum: Volume No. 32(1) Page 135