(klor proe' ma zeen hye'' droe klor' ide).
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 98.0 percent and not more than 101.5 percent of C17H19ClN2S·HCl, calculated on the dried basis.
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
B: The principal spot found in the test for Other alkylated phenothiazines corresponds in RF to the spot from the Standard solution.
C: A solution (1 in 10) responds to the tests for Chloride 191.
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%).
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.
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USP35NF30 Page 2643Pharmacopeial Forum: Volume No. 29(6) Page 1860