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].

Packaging and storage— Preserve in tight, light-resistant containers.

USP Reference standards 11— USP Chlorpromazine Hydrochloride RS.

Identification—

Melting range 741: between 195 and 198.

Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.

Residue on ignition 281: not more than 0.1%.

Other alkylated phenothiazines— Dissolve 50 mg, previously dried, in methanol to make 10 mL, and mix. Proceed as directed in the test for Other alkylated phenothiazines under 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 I 467: meets the requirements.

Residual solvents 467: meets the requirements.

Assay— Transfer to a beaker about 700 mg of Chlorpromazine Hydrochloride, accurately weighed, and dissolve in 75 mL of glacial acetic acid. Add 10 mL of mercuric acetate TS, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Each mL of 0.1 N perchloric acid is equivalent to 35.53 mg of C17H19ClN2S·HCl.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 493

Phone Number : 1-301-816-8330