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
.
Specific rotation 781S:
between
33.0
and
35.5
.
Test solution:
50 mg per mL, in water.
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.
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—
Test solution:
alcohol.
Standard solution:
alcohol.
Eluant:
a mixture of isopropyl alcohol, ammonium hydroxide, and chloroform (80:15:5).
Visualization:
1, followed by 4.
Organic volatile impurities, Method I 467:
meets the requirements.
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 C
10H
15NO·HCl.
Auxiliary Information—
Staff Liaison :
Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 803
Pharmacopeial Forum : Volume No. 30(3) Page 839
Phone Number : 1-301-816-8143
-[1-(methylamino)ethyl]-, hydrochloride, [R-(R*,S*)]-.