(e fed' rin hye'' droe klor' ide).
Benzenemethanol, -[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.
USP Reference standards 11
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.
Melting range, Class I 741: between 217 and 220.
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.
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%.
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.
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.
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USP35NF30 Page 3050Pharmacopeial Forum: Volume No. 30(3) Page 839