Emetine Hydrochloride Injection
»Emetine Hydrochloride Injection is a sterile solution of Emetine Hydrochloride in Water for Injection.It contains an amount of anhydrous emetine hydrochloride (C29H40N2O4·2HCl)equivalent to not less than 84.0percent and not more than 94.0percent of the labeled amount of emetine hydrochloride.
Packaging and storage— Preserve in single-dose,light-resistant containers,preferably of Type Iglass.
Identification—
A: Evaporate 1mLof Injection on a steam bath to dryness:the residue responds to Identificationtest Aunder Emetine Hydrochloride.
B: The Injection responds to Identificationtest Cunder Emetine Hydrochloride.
Bacterial endotoxins á85ñ— It contains not more than 5.4USP Endotoxin Units per mg of emetine hydrochloride.
pHá791ñ: between 3.0and 5.0.
Limit of cephaeline— [NOTE—Conduct this test in subdued light until after the chromatogram has been completely developed.]
Standard preparation and Spray reagent—Prepare as directed in the test for Limit of cephaelineunder Emetine Hydrochloride.
Test preparation— Evaporate 1.0mLof Injection on a steam bath with the aid of a stream of nitrogen just to dryness.Dissolve the residue in a sufficient volume of methanol to obtain a Test preparationhaving a concentration of 10mg of emetine hydrochloride per mL.
Procedure— Proceed as directed for Procedurein the test for Limit of cephaelineunder Emetine Hydrochloride.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer an accurately measured volume of Injection,equivalent to about 120mg of emetine hydrochloride,to a suitable extraction apparatus containing about 20mLof water.Add 6Nammonium hydroxide until the solution is strongly alkaline,and extract with ether until 0.5mLof the water layer,slightly acidified with hydrochloric acid,remains unaffected by the addition of a few drops of mercuric-potassium iodide TS.Evaporate the combined ether extracts on a steam bath,allowing the last few mLof the ether to evaporate spontaneously.Add to the residue 2mLof neutralized alcohol and 30.0mLof 0.02Nsulfuric acid VS,and warm gently until the alkaloid is dissolved.Cool,add methyl red TS,and titrate the excess acid with 0.02Nsodium hydroxide VS.Each mLof 0.02Nsulfuric acid is equivalent to 5.536mg of C29H40N2O4·2HCl.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 730
Phone Number:1-301-816-8394