Mesoridazine Besylate Injection
»Mesoridazine Besylate Injection is a sterile solution of Mesoridazine Besylate in Water for Injection.It contains mesoridazine besylate (C21H26N2OS2·C6H6O3S)equivalent to not less than 90.0percent and not more than 110.0percent of the labeled amount of mesoridazine (C21H26N2OS2).
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass,protected from light.
USP Reference standards á11ñ— USP Endotoxin RS.USP Mesoridazine Besylate 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— Dilute a volume of Injection,equivalent to about 50mg of mesoridazine besylate,with 0.01Nhydrochloric acid 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.
Bacterial endotoxins á85ñ— It contains not more than 7.0USP Endotoxin Units per mg of mesoridazine besylate.
pHá791ñ: between 4.0and 5.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— [NOTE—Conduct this procedure with minimum exposure to light.]Proceed with Injection as directed under Salts of Organic Nitrogenous Bases á501ñ,except to use 1.0mLeach of the Standard Preparationand the Assay Preparationin the Procedure,and determine the absorbances at the wavelength of maximum absorbance at about 262nm.Calculate the quantity,in mg,of C21H26N2OS2in each mLof the Injection taken by the formula:
(386.59/544.75)(0.05C/V)(AU/AS),
in which 386.59and 544.75are the molecular weights of mesoridazine and mesoridazine besylate,respectively;Cis the concentration,in µg per mL,of USP Mesoridazine Besylate RSin the Standard Preparation;and Vis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1224
Phone Number:1-301-816-8330