(C10H15NO)2·H2SO4 428.54

Benzenemethanol, -[1-(methylamino)ethyl]-, [R-(R*,S*)]-, sulfate (2:1) (salt).
()-Ephedrine sulfate (2:1) (salt) [134-72-5].

Packaging and storage— Preserve in well-closed, light-resistant containers.

USP Reference standards 11— USP Ephedrine Sulfate RS.

Identification—

Specific rotation 781S: between 30.5 and 32.5.

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—

Organic volatile impurities, Method I 467: meets the requirements.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 804

Phone Number : 1-301-816-8143