Chlorpheniramine Maleate Injection
»Chlorpheniramine Maleate Injection is a sterile solution of Chlorpheniramine Maleate in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C16H19ClN2·C4H4O4.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass,protected from light.
Identification—
A: Dilute a volume of Injection,equivalent to about 50mg of chlorpheniramine maleate,with dilute hydrochloric acid (1in 1000)to 25mL,and proceed as directed under Identification—Organic Nitrogenous Bases á181ñ,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 25mg of chlorpheniramine maleate,on a steam bath to dryness,and dry the residue at 105for 1hour:it melts between 128and 135.
Bacterial endotoxins á85ñ— It contains not more than 8.8USP Endotoxin Units per mg of chlorpheniramine maleate.
pHá791ñ: between 4.0and 5.2.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Proceed with Injection as directed under Salts of Organic Nitrogenous Bases á501ñ,to prepare the solution employed for the determination of the absorbance,AU,at 264nm.For the determination of AS,dissolve about 25mg of USP Chlorpheniramine Maleate RS,accurately weighed,in 20mLof dilute sulfuric acid (1in 350),and treat this solution the same as the portion of Injection being assayed.Calculate the quantity,in mg,of C16H19ClN2·C4H4O4in each mLof the Injection taken by the formula:
(C/V)(AU/AS),
in which Cis the weight,in mg,of USP Chlorpheniramine Maleate RSin the Standard preparation,and Vis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 449
Phone Number:1-301-816-8379