Ephedrine Hydrochloride
C10H15NO·HCl
201.69
201.69Benzenemethanol,
-[1-(methylamino)ethyl]-, hydrochloride, [R-(R*,S*)]-.
(
)-Ephedrine hydrochloride
[50-98-6].» Ephedrine 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 well-closed, light-resistant containers.
Identification—
A:
Dissolve 100 mg in 5 mL of water, add 1 mL of potassium carbonate solution (1 in 5), and extract with 2 mL of chloroform: the IR absorption spectrum of the chloroform extract so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Ephedrine Sulfate RS.
B:
A solution of it responds to the tests for Chloride 
191
.
191.
Acidity or alkalinity—
Dissolve 1.0 g in 20 mL of water, and add 1 drop of methyl red TS. If the solution is yellow, it is changed to red by not more than 0.10 mL of 0.020 N sulfuric acid. If the solution is pink, it is changed to yellow by not more than 0.20 mL of 0.020 N sodium hydroxide.
Loss on drying 731—
Dry it at 105
for 3 hours: it loses not more than 0.5% of its weight.
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%.
281:
not more than 0.1%.
Sulfate—
Dissolve 50 mg in 40 mL of water, and add 1 mL of 3 N hydrochloric acid and 1 mL of barium chloride TS: no turbidity develops within 10 minutes.
Ordinary impurities 466—
466—
Test solution:
alcohol.
Standard solution:
alcohol.
Eluant:
a mixture of isopropyl alcohol, ammonium hydroxide, and chloroform (80:15:5).
Visualization:
1, followed by 4.
Assay—
Dissolve about 500 mg of Ephedrine Hydrochloride, accurately weighed, in 25 mL of glacial acetic acid. Add 10 mL of mercuric acetate TS and 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to an emerald-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.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Daniel K. Bempong, Ph.D.
Senior Scientist 1-301-816-8143 |
(MDPS05) Monograph Development-Pulmonary and Steroids |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 2258
Pharmacopeial Forum: Volume No. 30(3) Page 839
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.