Chlorpheniramine Maleate Injection
» Chlorpheniramine Maleate Injection is a sterile solution of Chlorpheniramine Maleate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C16H19ClN2·C4H4O4.
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light.
A: Dilute a volume of Injection, equivalent to about 50 mg of chlorpheniramine maleate, with dilute hydrochloric acid (1 in 1000) to 25 mL, and proceed as directed under Identification—Organic Nitrogenous Bases 181, beginning with “Transfer the liquid to a separator.” The Injection meets the requirements of the test.
B: Evaporate a volume of Injection, equivalent to about 25 mg of chlorpheniramine maleate, on a steam bath to dryness, and dry the residue at 105 for 1 hour: it melts between 128 and 135.
Bacterial endotoxins 85 It contains not more than 8.8 USP Endotoxin Units per mg of chlorpheniramine maleate.
pH 791: between 4.0 and 5.2.
Other requirements— It meets the requirements under Injections 1.
Assay— Proceed with Injection as directed under Salts of Organic Nitrogenous Bases 501, to prepare the solution employed for the determination of the absorbance, AU, at 264 nm. For the determination of AS, dissolve about 25 mg of USP Chlorpheniramine Maleate RS, accurately weighed, in 20 mL of dilute sulfuric acid (1 in 350), and treat this solution the same as the portion of Injection being assayed. Calculate the quantity, in mg, of C16H19ClN2·C4H4O4 in each mL of the Injection taken by the formula:
(C / V)(AU / AS)
in which C is the weight, in mg, of USP Chlorpheniramine Maleate RS in the Standard preparation, and V is the volume, in mL, of Injection taken.
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 1908