Promethazine Hydrochloride Injection
» Promethazine Hydrochloride Injection is a sterile solution of Promethazine 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 Promethazine 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.
Identification— Add a volume of Injection, equivalent to about 50 mg of promethazine hydrochloride, to 20 mL of dilute hydrochloric acid (1 in 1000) contained in a separator. Wash the solution with a 20-mL portion of methylene chloride, discarding the washing. Add 2 mL of 1 N sodium hydroxide and 20 mL of methylene chloride, and shake for 2 minutes. Evaporate the methylene chloride extract on a steam bath with the aid of a stream of nitrogen to dryness. Dissolve the residue in 4 mL of carbon disulfide, filter through paper, if necessary, and determine the IR absorption spectrum as directed under Identification—Organic Nitrogenous Bases 181, obtaining the spectrum of USP Promethazine Hydrochloride RS as directed: the Injection meets the requirements of the test.
Bacterial endotoxins 85 It contains not more than 5.0 USP Endotoxin Units per mg of promethazine hydrochloride.
pH 791: between 4.0 and 5.5.
Other requirements— It meets the requirements under Injections 1.
Mobile phase— Dissolve 1 g of sodium 1-pentanesulfonate in 500 mL of water, add 500 mL of acetonitrile and 5 mL of glacial acetic acid, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Promethazine Hydrochloride RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with the same solvent to obtain a solution having a known concentration of about 0.1 mg per mL.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 50 mg of promethazine hydrochloride, to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 10.0 mL of the resulting solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
System suitability preparation— Dissolve a suitable quantity of phenothiazine in Standard preparation to obtain a solution containing about 10 µg of phenothiazine per mL.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 30-cm column that contains packing L11. The flow rate is about 1.5 mL per minute. Chromatograph the System suitability preparation, and record the peak responses as directed for Procedure: the resolution, R, between the promethazine and phenothiazine peaks is not less than 3.0, and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 30 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. The relative retention times are 1.0 for promethazine and about 1.6 for phenothiazine. Calculate the quantity, in mg, of C17H20N2S·HCl in each mL of the Injection taken by the formula:
500(C / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Promethazine Hydrochloride RS in the Standard preparation, V is the volume, in mL, of Injection taken, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, 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
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3406
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.