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

Labeling— Label it to indicate that it must be diluted prior to administration.

USP Reference standards 11— USP Chlorpromazine Hydrochloride RS.

Identification—

Microbial limits 61— It meets the requirements of the tests for the absence of Escherichia coli.

pH 791: between 2.3 and 4.1.

Limit of chlorpromazine sulfoxide— Proceed as directed in the test for Chlorpromazine sulfoxide under Chlorpromazine Hydrochloride Syrup.

Residual solvents 467: meets the requirements.

Assay— Transfer an accurately measured volume of Oral Concentrate, previously diluted if necessary, equivalent to about 10 mg of chlorpromazine hydrochloride, to a 50-mL volumetric flask, add 0.1 N hydrochloric acid to volume, and mix. Proceed as directed in the Assay under Chlorpromazine Hydrochloride Injection, beginning with “Pipet 10 mL of the solution.” Calculate the quantity, in mg, of C17H19ClN2S·HCl in each mL of the Oral Concentrate taken by the formula: in which C is the concentration, in µg per mL, of USP Chlorpromazine Hydrochloride RS in the Standard solution; V is the volume, in mL, of Oral Concentrate taken; 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 Oral Concentrate (U) and the Standard solution (S), respectively.

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

USP29–NF24 Page 493

Phone Number : 1-301-816-8330