Chlorpromazine Hydrochloride Oral Concentrate
» Chlorpromazine Hydrochloride Oral Concentrate contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C17H19ClN2S·HCl.
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
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: It responds to Identification test A under Chlorpromazine Hydrochloride Syrup.
B: Dilute a portion of the Oral Concentrate with an equal volume of water: the resulting solution responds to the tests for Chloride 191.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 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.
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:
1.25C(A254 A277)U / V(A254 A277)S
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1914