Chlorpromazine Hydrochloride
C17H19ClN2S·HCl
355.33
10H-Phenothiazine-10-propanamine,2-chloro-N,N-dimethyl-,monohydrochloride.
2-Chloro-10-[3-(dimethylamino)propyl]phenothiazine monohydrochloride [69-09-0].
»Chlorpromazine Hydrochloride contains not less than 98.0percent and not more than 101.5percent of C17H19ClN2S·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,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.
Identification—
A:
Infrared Absorption á197Kñ.
B:
The principal spot found in the test for Other alkylated phenothiazinescorresponds in RFto the spot from the Standard solution.
C:
Asolution (1in 10)responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Other alkylated phenothiazines—
Dissolve 50mg,previously dried,in methanol to make 10mL,and mix.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 of Chlorpromazine Hydrochloride are not greater than those of the spot from the Diluted standard solution(0.5%).
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer to a beaker about 700mg of Chlorpromazine Hydrochloride,accurately weighed,and dissolve in 75mLof glacial acetic acid.Add 10mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Each mLof 0.1Nperchloric acid is equivalent to 35.53mg of C17H19ClN2S·HCl.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 455
Pharmacopeial Forum:Volume No.29(6)Page 1860
Phone Number:1-301-816-8330