Ephedrine Sulfate
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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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.
1 Packaging and storage
—Preserve in well-closed, light-resistant containers.
USP Reference standards 〈11〉—
USP Ephedrine Sulfate RS
2 Identification—
Change to read:
A: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020) .
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.
