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.
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 Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2259