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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 95.0percent and not more than 105.0percent 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 Iglass.
Identification—
A:
Mix 1mLof Injection with 5mLof alcohol,and evaporate on a steam bath with the aid of a current of air to dryness:the residue so obtained responds to Identificationtests under Ephedrine Sulfate.
B:
It responds to the tests for Sulfate á191ñ.
Bacterial endotoxins á85ñ—
It contains not more than 1.7USP Endotoxin Units per mg of ephedrine sulfate.
pHá791ñ:
between 4.5and 7.0.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Transfer an accurately measured volume of Injection,equivalent to about 250mg of ephedrine sulfate,to a separator,add water,if necessary,to make about 10mL,and proceed as directed in the Assayunder Ephedrine Sulfate,beginning with “Saturate the solution.”
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 738
Phone Number:1-301-816-8379
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