U.S. PHARMACOPEIA

Search USP29  
Prilocaine Hydrochloride
Click to View Image
C13H20N2O·HCl 256.77

Propanamide, N-(2-methylphenyl)-2-(propylamino)-, monohydrochloride.
2-(Propylamino)-o-propionotoluidide monohydrochloride [1786-81-8].
» Prilocaine Hydrochloride contains not less than 99.0 percent and not more than 101.0 percent of C13H20N2O·HCl, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Identification—
B: Dissolve about 300 mg in 5 mL of water, add 4 mL of 6 N ammonium hydroxide, and extract with 50 mL of chloroform. Filter the extract, and evaporate the filtrate on a steam bath with the aid of a current of air. Dissolve about 100 mg of the prilocaine so obtained in 1 mL of alcohol, add 10 drops of cobaltous chloride TS, and shake for 2 minutes: a bright green color develops, and a precipitate is formed.
C: Dissolve about 100 mg in 3 mL of water, render the solution alkaline with 6 N ammonium hydroxide, and filter: the filtrate responds to the tests for Chloride 191.
Melting range, Class I 741: between 166 and 169.
Loss on drying 731 Dry it at 105 for 4 hours: it loses not more than 0.3% of its weight.
Residue on ignition 281: not more than 0.1%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 500 mg of Prilocaine Hydrochloride, accurately weighed, in 50 mL of glacial acetic acid, add 10 mL of mercuric acetate TS and 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 25.68 mg of C13H20N2O·HCl.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1797
Pharmacopeial Forum : Volume No. 29(5) Page 1564
Phone Number : 1-301-816-8143