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
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.
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USP35NF30 Page 3051