Cocaine Hydrochloride Tablets for Topical Solution
»Cocaine Hydrochloride Tablets for Topical Solution contain not less than 91.0percent and not more than 109.0percent of the labeled amount of C17H21NO4·HCl.
Packaging and storage— Preserve in well-closed,light-resistant containers.
Identification—
A: Add 5drops of chromium trioxide solution (1in 20)to 5mLof a filtered solution of Tablets,equivalent to cocaine hydrochloride solution (1in 50):a yellow precipitate is formed and it redissolves when the mixture is shaken.On the addition of 1mLof hydrochloric acid,a permanent,yellowish orange,crystalline precipitate is formed.
B: Dissolve a portion of powdered Tablets,equivalent to about 10mg of cocaine hydrochloride,in 1mLof water,filter,and add 2mLof 0.1Npotassium permanganate:a red-purple,crystalline precipitate,which appears brown when collected on a filter,is formed,and it shows characteristic,crystalline aggregates under the low power of a microscope.
C: Add silver nitrate TS,dropwise,to a filtered solution of Tablets,equivalent to cocaine hydrochloride solution (1in 20):a white precipitate is formed,and it is insoluble in nitric acid.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— Place 1Tablet in a 100-mLvolumetric flask,add 50mLof water,and shake the flask until the tablet is dissolved.Dilute with water to volume,mix,and filter,discarding the first 20mLof the filtrate.Dilute a portion of the subsequent filtrate,if necessary,with water to provide a solution containing approximately 80µg of cocaine hydrochloride per mL.Concomitantly determine the absorbances of this test solution and a Standard solution of USP Cocaine Hydrochloride RSin the same medium having a known concentration of about 80µg per mL,in 1-cm cells at the wavelength of maximum absorbance at about 275nm,with a suitable spectrophotometer,using water as the blank.Calculate the quantity,in mg,of C17H21NO4·HCl in the Tablet by the formula:
(T/D)C(AU/AS),
in which Tis the labeled quantity,in mg,of cocaine hydrochloride in the Tablet;Dis the concentration,in µg per mL,of cocaine hydrochloride in the test solution,based upon the labeled quantity per Tablet and the extent of dilution;Cis the concentration,in µg per mL,of USP Cocaine Hydrochloride RSin the Standard solution;and AUand ASare the absorbances of the solution from the Tablet and the Standard solution,respectively.
Assay— Weigh and finely powder not fewer than 20Tablets.Dissolve an accurately weighed portion of the powder,equivalent to about 60mg of cocaine hydrochloride,in 10mLof water,render the solution slightly alkaline with 6Nammonium hydroxide,and completely extract the cocaine with small successive portions of ether.Evaporate the combined ether extracts on a steam bath to one-half their volume,transfer the remaining liquid to a separator,and wash with three 5-mLportions of water.Shake the water washings with a small portion of ether,and add the ether washing to the combined ether extracts.Add 10.0mLof 0.05Nsulfuric acid VSto the ether solution,agitate the mixture thoroughly,and draw off the acidified water layer into a beaker.Wash the ether with two small portions of water,add the washings to the acid liquid,and titrate the excess acid with 0.02Nsodium hydroxide VS,using methyl red TSas the indicator.Each mLof 0.05Nsulfuric acid is equivalent to 16.99mg 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
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