Cocaine Hydrochloride
C17H21NO4·HCl 339.81

8-Azabicyclo[3.2.1]octane-2-carboxylic acid,3-(benzoyloxy)-8-methyl-,methyl ester,hydrochloride,1R-(exo,exo)-.

Methyl 3b-hydroxy-1aH,5aH-tropan-2b-carboxylate,benzoate (ester)hydrochloride [53-21-4].
»Cocaine Hydrochloride contains not less than 99.0percent and not more than 101.0percent of C17H21NO4·HCl,calculated on the dried basis.
Packaging and storage— Preserve in well-closed,light-resistant containers.
Identification—
A: It meets the requirements under Identification—Organic Nitrogenous Bases á181ñ,sodium carbonate TSbeing used in place of 1Nsodium hydroxide.
B: To 5mLof a solution (1in 50)add 5drops of chromium trioxide solution (1in 20):a yellow precipitate is formed,and it quickly redissolves when the mixture is shaken gently.Add 1mLof hydrochloric acid:a permanent,orange-colored crystalline precipitate is formed.
C: To a solution of about 10mg in 2drops of water add 1mLof 0.1Npotassium permanganate:a violet,crystalline precipitate is formed,and it appears brownish violet when collected on a filter,and shows characteristic,violet-red crystalline aggregates under the low power of a microscope.
D: It responds to the tests for Chloride á191ñ.
Specific rotation á781Sñ: between -71and -73.
Test solution: 20mg,previously dried,per mL,in water.
Acidity— Dissolve 500mg in 10mLof water,add 1drop of methyl red TS,and titrate with 0.020Nsodium hydroxide:not more than 0.50mLis required to produce a yellow color.
Loss on drying á731ñ— Dry it over silica gel for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ: not more than 0.1%.
Readily carbonizable substances á271ñ— Dissolve 500mg in 5mLof sulfuric acid TS:the solution has no more color than Matching Fluid F.
Limit of cinnamyl-cocaine and other reducing substances— To 5mLof a solution (1in 50)add 0.3mLof 1Nsulfuric acid and 0.10mLof 0.10Npotassium permanganate:the violet color does not disappear entirely within 30minutes.
Limit of isoatropyl-cocaine— Dilute 5mLof a solution (1in 50)in a beaker with 80mLof water,add 0.2mLof 6Nammonium hydroxide,stir the solution vigorously during 5minutes,occasionally rubbing the inner wall of the beaker with a stirring rod:a crystalline precipitate of cocaine is formed,and the supernatant is clear.
Assay— Dissolve about 500mg of Cocaine Hydrochloride,accurately weighed,in a mixture of 40mLof glacial acetic acid and 10mLof mercuric acetate TS.Add 2drops of quinaldine red TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 33.98mg of C17H21NO4·HCl.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 531
Phone Number:1-301-816-8343