Promazine Hydrochloride Syrup
»Promazine Hydrochloride Syrup contains not less than 95.0percent and not more than 110.0percent of the labeled amount of C17H20N2S·HCl.
Packaging and storage— Preserve in tight,light-resistant containers.
USP Reference standards á11ñ— USP Promazine 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— It responds to Identificationtest Bunder Promazine Hydrochloride.
Assay— [NOTE—Use low-actinic glassware.]Transfer a volume of Syrup,equivalent to about 10mg of promazine hydrochloride,to a 250-mLseparator.Proceed as directed in the Assayunder Promazine Hydrochloride Oral Solution,beginning with “Add water to adjust the volume to about 45mL.”Calculate the quantity,in mg,of C17H20N2S·HCl in each mLof the Syrup taken by the formula:
(0.25C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Promazine Hydrochloride RSin the Standard solution,Vis the volume,in mL,of Syrup taken,and AUand ASare the absorbances of the solution from the Syrup and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1640
Phone Number:1-301-816-8379