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 84.0 percent and not more than 94.0 percent of the labeled amount of emetine hydrochloride.
Packaging and storage— Preserve in single-dose, light-resistant containers, preferably of Type I glass.
Identification—
A: Evaporate 1 mL of Injection on a steam bath to dryness: the residue responds to Identification test A under Emetine Hydrochloride.
B: The Injection responds to Identification test C under Emetine Hydrochloride.
Bacterial endotoxins 85— It contains not more than 5.4 USP Endotoxin Units per mg of emetine hydrochloride.
pH 791: between 3.0 and 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 cephaeline under Emetine Hydrochloride.
Test preparation— Evaporate 1.0 mL of 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 preparation having a concentration of 10 mg of emetine hydrochloride per mL.
Procedure— Proceed as directed for Procedure in the test for Limit of cephaeline under Emetine Hydrochloride.
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer an accurately measured volume of Injection, equivalent to about 120 mg of emetine hydrochloride, to a suitable extraction apparatus containing about 20 mL of water. Add 6 N ammonium hydroxide until the solution is strongly alkaline, and extract with ether until 0.5 mL of 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 mL of the ether to evaporate spontaneously. Add to the residue 2 mL of neutralized alcohol and 30.0 mL of 0.02 N sulfuric acid VS, and warm gently until the alkaloid is dissolved. Cool, add methyl red TS, and titrate the excess acid with 0.02 N sodium hydroxide VS. Each mL of 0.02 N sulfuric acid is equivalent to 5.536 mg of C29H40N2O4·2HCl.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Behnam Davani, Ph.D., M.B.A.
Senior Scientist
1-301-816-8394		 (MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2247