Chlorpromazine Hydrochloride Tablets
»Chlorpromazine Hydrochloride Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of C17H19ClN2S·HCl.
Packaging and storage— Preserve in well-closed,light-resistant containers.
USP Reference standards á11ñ USP Chlorpromazine Hydrochloride RS.
NOTE—Throughout the following procedures,protect test or assay specimens,the Reference Standard,and solutions containing them,by conducting the procedures without delay,under subdued light,or using low-actinic glassware.
A: Tablets respond to Identificationtest Bunder Chlorpromazine Hydrochloride.
B: Digest a quantity of powdered Tablets,equivalent to about 25mg of chlorpromazine hydrochloride,with 25mLof water,and filter:the solution so obtained responds to Identificationtest Cunder Chlorpromazine Hydrochloride.
Dissolution á711ñ
Medium: 0.1Nhydrochloric acid;900mL.
Apparatus 1: 50rpm.
Time: 30minutes.
Procedure— Determine the amount of C17H19ClN2S·HCl dissolved from UVabsorbances at the wavelength of maximum absorbance at about 254nm of filtered portions of the solution under test,suitably diluted with Dissolution Medium,in comparison with a Standard solution having a known concentration of USP Chlorpromazine Hydrochloride RSin the same medium.
Tolerances— Not less than 80%(Q)of the labeled amount of C17H19ClN2S·HCl is dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Other alkylated phenothiazines— Transfer a portion of finely powdered Tablets,equivalent to 50mg of chlorpromazine hydrochloride,to a stoppered centrifuge tube,add 10mLof methanol,shake vigorously,and centrifuge (remove any sugar coating by prior washing with water).Proceed as directed in the test for Other alkylated phenothiazinesunder Chlorpromazine,beginning with “Dissolve a suitable quantity of USP Chlorpromazine Hydrochloride RS.”The area and intensity of any spot,other than the principal spot,from the solution from the Tablets are not greater than those of the spot from the Diluted standard solution(0.5%).
Assay— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of chlorpromazine hydrochloride,to a 500-mLvolumetric flask.Add about 200mLof water and 5mLof hydrochloric acid,insert the stopper,and shake for about 10minutes.Dilute with water to volume,and mix.Filter a portion of the solution,discarding the first 50mLof the filtrate.Treat 10.0mLof the filtrate as directed in the Assayunder Chlorpromazine Hydrochloride Injection,beginning with “Pipet 10mLof the solution.”Calculate the quantity,in mg,of C17H19ClN2S·HCl in the portion of Tablets taken by the formula:
in which Cis the concentration,in µg per mL,of USP Chlorpromazine Hydrochloride RSin the Standard solution,and the parenthetic expressions are the differences in the absorbances of the two solutions at the wavelengths indicated by the subscripts,for the solution from the Tablets (U)and the Standard solution (S),respectively.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 457
Phone Number:1-301-816-8330