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.
USP Reference standards 11
USP Endotoxin RS
USP Ephedrine Sulfate RS Click to View Structure
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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 3051