Succinylcholine Chloride Injection
»Succinylcholine Chloride Injection is a sterile solution of Succinylcholine Chloride in a suitable aqueous vehicle.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of anhydrous succinylcholine chloride (C14H30Cl2N2O4).
Packaging and storage Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIglass,in a refrigerator.
Labeling Label it to indicate,as its expiration date,the month and year not more than 2years from the month during which the Injection was last assayed and released by the manufacturer.
Identification It responds to Identificationtests Band Cunder Succinylcholine Chloride.
Bacterial endotoxins á85ñ It contains not more than 2.0USP Endotoxin Units per mg of succinylcholine chloride.
pHá791ñ: between 3.0and 4.5.
Other requirements It meets the requirements under Injections á1ñ.
Assay [NOTESince the Mobile phase employed in this procedure has a fairly high concentration of chloride ion and a low pH,it may be advisable to rinse the entire system with water following the use of this Mobile phase.]
Mobile phase and Chromatographic systemPrepare as directed in the Assayunder Succinylcholine Chloride.
Standard preparation Transfer about 88mg of USP Succinylcholine Chloride RS,accurately weighed,to a 10-mLvolumetric flask,add a volume of water to correspond to the solvent composition of the Assay preparation,and dilute with Mobile phaseto volume while mixing.Prepare the Standard preparationconcurrently with the Assay preparation.
Assay preparation Transfer a volume of Injection,equivalent to about 80mg of anhydrous succinylcholine chloride,to a 10-mLvolumetric flask,and dilute with Mobile phaseto volume while mixing.
Procedure Proceed as directed for Procedurein the Assayunder Succinylcholine Chloride.Calculate the quantity,in mg,of anhydrous succinylcholine chloride (C14H30Cl2N2O4)in each mLof the Injection taken by the formula:
(10C/V)(rU/rS),in which Vis the volume,in mL,of Injection taken.
Auxiliary Information Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1