U.S. PHARMACOPEIA

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Ephedrine Sulfate Injection
» Ephedrine Sulfate Injection is a sterile solution of Ephedrine Sulfate in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of (C10H15NO)2·H2SO4.
Packaging and storage— Preserve in single-dose or in multiple-dose, light-resistant containers, preferably of Type I glass.
Identification—
A: Mix 1 mL of Injection with 5 mL of alcohol, and evaporate on a steam bath with the aid of a current of air to dryness: the residue so obtained responds to Identification tests under Ephedrine Sulfate.
B: It responds to the tests for Sulfate 191.
Bacterial endotoxins 85— It contains not more than 1.7 USP Endotoxin Units per mg of ephedrine sulfate.
pH 791: between 4.5 and 7.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer an accurately measured volume of Injection, equivalent to about 250 mg of ephedrine sulfate, to a separator, add water, if necessary, to make about 10 mL, and proceed as directed in the Assay under Ephedrine Sulfate, beginning with “Saturate the solution.”
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 805
Phone Number : 1-301-816-8143