Ephedrine Sulfate
(C10H15NO)2·H2SO4 428.54

Benzenemethanol, -[1-(methylamino)ethyl]-, [R-(R*,S*)]-, sulfate (2:1) (salt).
()-Ephedrine sulfate (2:1) (salt) [134-72-5].
» Ephedrine Sulfate contains not less than 98.0 percent and not more than 101.0 percent of (C10H15NO)2·H2SO4, calculated on the dried basis.
Packaging and storage— Preserve in well-closed, light-resistant containers.
B: A solution of it responds to the tests for Sulfate 191.
Specific rotation 781S: between 30.5 and 32.5.
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 about 500 mg, accurately weighed, at 105 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Chloride 221 A 200-mg portion shows no more chloride than corresponds to 0.40 mL of 0.020 N hydrochloric acid (0.14%).
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— Transfer about 300 mg of Ephedrine Sulfate, accurately weighed, to a separator, and dissolve in about 10 mL of water. Saturate the solution with sodium chloride (about 3 g), add 5 mL of 1 N sodium hydroxide, and extract with four 25-mL portions of chloroform. Wash the combined chloroform extracts by shaking with 10 mL of a saturated solution of sodium chloride, and filter through chloroform-saturated purified cotton into a beaker. Extract the wash solution with 10 mL of chloroform, and add to the main chloroform extract. Add methyl red TS, and titrate with 0.1 N perchloric acid in dioxane VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 21.43 mg of (C10H15NO)2·H2SO4.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2258
Pharmacopeial Forum: Volume No. 30(3) Page 840
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.