Promazine Hydrochloride Injection
» Promazine Hydrochloride Injection is a sterile solution of Promazine Hydrochloride in Water for Injection. It 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 single-dose or in multiple-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Promazine Hydrochloride RS
USP Endotoxin 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 meets the requirements under Identification—Organic Nitrogenous Bases 181.
B: It responds to Identification test B under Promazine Hydrochloride.
Bacterial endotoxins 85 It contains not more than 1.8 USP Endotoxin Units per mg of promazine hydrochloride.
pH 791: between 4.0 and 5.5.
Other requirements— It meets the requirements under Injections 1.
Assay— [note—Use low-actinic glassware.] Transfer a volume of Injection, equivalent to about 50 mg of promazine hydrochloride, to a 100-mL volumetric flask, dilute with 0.1 N hydrochloric acid to volume, and mix. Transfer 10.0 mL of the solution to a 250-mL separator, add 20 mL of water, render alkaline with ammonium hydroxide, and extract with four 25-mL portions of ether. Extract the combined ether extracts with five 15-mL portions of 0.1 N hydrochloric acid, collecting the aqueous extracts in a 100-mL volumetric flask. Aerate to remove residual ether, dilute with 0.1 N hydrochloric acid to volume, and mix. Without delay, concomitantly determine the absorbances of this solution and of a Standard solution of USP Promazine Hydrochloride RS in the same medium having a known concentration of about 50 µg per mL in 1-cm cells at the wavelength of maximum absorbance at about 301 nm, with a suitable spectrophotometer, using 0.1 N hydrochloric acid as the blank. Calculate the quantity, in mg, of C17H20N2S·HCl in each mL of the Injection taken by the formula:
(C / 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 Injection taken, and AU and AS are the absorbances of the solution from the Injection and the Standard solution, respectively.
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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
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3404