Chlorpromazine Hydrochloride Oral Concentrate
»Chlorpromazine Hydrochloride Oral Concentrate contains not less than 90.0percent and not more than 110.0percent 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 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: It responds to Identificationtest Aunder 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 á191ñ.
Microbial limits á61ñ— It meets the requirements of the tests for the absence of Escherichia coli.
pHá791ñ: between 2.3and 4.1.
Limit of chlorpromazine sulfoxide— Proceed as directed in the test for Chlorpromazine sulfoxideunder Chlorpromazine Hydrochloride Syrup.
Assay— Transfer an accurately measured volume of Oral Concentrate,previously diluted if necessary,equivalent to about 10mg of chlorpromazine hydrochloride,to a 50-mLvolumetric flask,add 0.1Nhydrochloric acid to volume,and mix.Proceed as directed in the Assayunder Chlorpromazine Hydrochloride Injection,beginning with “Pipet 10mLof the solution.”Calculate the quantity,in mg,of C17H19ClN2S·HCl in each mLof the Oral Concentrate taken by the formula:
1.25C(A254-A277)U/V(A254-A277)S,
in which Cis the concentration,in µg per mL,of USP Chlorpromazine Hydrochloride RSin the Standard solution,Vis 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— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 455
Phone Number:1-301-816-8330