Ephedrine Sulfate
(C10H15NO)2·H2SO4
428.54
Benzenemethanol,a-[1-(methylamino)ethyl]-,[R-(R*,S*)]-,sulfate (2:1)(salt).
(-)-Ephedrine sulfate (2:1)(salt) [134-72-5].
»Ephedrine Sulfate contains not less than 98.0percent and not more than 101.0percent of (C10H15NO)2·H2SO4,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Asolution of it responds to the tests for Sulfate á191ñ.
Specific rotation á781Sñ:
between -30.5
and -32.5.
and -32.5.
Test solution:
50mg per mL,in water.
Acidity or alkalinity—
Dissolve 1.0g in 20mLof water,and add 1drop of methyl red TS.If the solution is yellow,it is changed to red by not more than 0.10mLof 0.020Nsulfuric acid.If the solution is pink,it is changed to yellow by not more than 0.20mLof 0.020Nsodium hydroxide.
Loss on drying á731ñ—
Dry about 500mg,accurately weighed,at 105for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Chloride á221ñ—
A200-mg portion shows no more chloride than corresponds to 0.40mLof 0.020Nhydrochloric acid (0.14%).
Ordinary impurities á466ñ—
Test solution:
alcohol.
Standard solution:
alcohol.
Eluant:
a mixture of isopropyl alcohol,3.6Mammonium hydroxide,and chloroform (80:15:5).
Visualization:
1,followed by 4.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer about 300mg of Ephedrine Sulfate,accurately weighed,to a separator,and dissolve in about 10mLof water.Saturate the solution with sodium chloride (about 3g),add 5mLof 1Nsodium hydroxide,and extract with four 25-mLportions of chloroform.Wash the combined chloroform extracts by shaking with 10mLof a saturated solution of sodium chloride,and filter through chloroform-saturated purified cotton into a beaker.Extract the wash solution with 10mLof chloroform,and add to the main chloroform extract.Add methyl red TS,and titrate with 0.1Nperchloric acid in dioxane VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 21.43mg of (C10H15NO)2·H2SO4.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 737
Pharmacopeial Forum:Volume No.30(3)Page 840
Phone Number:1-301-816-8379