(pril' oh kane hye'' droe klor' ide).
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.
USP Reference standards 11
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%.
Heavy metals, Method I 231: 0.002%.
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.
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USP35NF30 Page 4410Pharmacopeial Forum: Volume No. 29(5) Page 1564