Ephedrine Hydrochloride
C10H15NO·HCl
201.69
Benzenemethanol,a-[1-(methylamino)ethyl]-,hydrochloride,[R-(R*,S*)]-.
(-)-Ephedrine hydrochloride [50-98-6].
»Ephedrine Hydrochloride contains not less than 98.0percent and not more than 100.5percent of C10H15NO·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
A:
Dissolve 100mg in 5mLof water,add 1mLof potassium carbonate solution (1in 5),and extract with 2mLof chloroform:the IRabsorption spectrum of the chloroform extract so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Ephedrine Sulfate RS.
B:
Asolution of it responds to the tests for Chloride á191ñ.
Specific rotation á781Sñ:
between -33.0
and -35.5.
and -35.5.
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 it 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%.
Sulfate—
Dissolve 50mg in 40mLof water,and add 1mLof 3Nhydrochloric acid and 1mLof barium chloride TS:no turbidity develops within 10minutes.
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—
Dissolve about 500mg of Ephedrine Hydrochloride,accurately weighed,in 25mLof glacial acetic acid.Add 10mLof mercuric acetate TSand 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto an emerald-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 20.17mg of C10H15NO·HCl.
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 839
Phone Number:1-301-816-8379