Promazine Hydrochloride Syrup
» Promazine Hydrochloride Syrup contains not less than 95.0 percent and not more than 110.0 percent of the labeled amount of C17H20N2S·HCl.
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standards 11
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 Identification test B under Promazine Hydrochloride.
Assay— [note—Use low-actinic glassware.] Transfer a volume of Syrup, equivalent to about 10 mg of promazine hydrochloride, to a 250-mL separator. Proceed as directed in the Assay under Promazine Hydrochloride Oral Solution, beginning with “Add water to adjust the volume to about 45 mL.” Calculate the quantity, in mg, of C17H20N2S·HCl in each mL of the Syrup taken by the formula:
(0.25C / V)(AU / AS)
in which C is the concentration, in µg per mL, of USP Promazine Hydrochloride RS in the Standard solution, V is the volume, in mL, of Syrup taken, and AU and AS are the absorbances of the solution from the Syrup and the Standard solution, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3405