Succinylcholine Chloride Injection
» Succinylcholine Chloride Injection is a sterile solution of Succinylcholine Chloride in a suitable aqueous vehicle. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of anhydrous succinylcholine chloride (C14H30Cl2N2O4).
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass, in a refrigerator.
Labeling Label it to indicate, as its expiration date, the month and year not more than 2 years from the month during which the Injection was last assayed and released by the manufacturer.
USP Reference standards 11
USP Endotoxin RS
Identification It responds to Identification tests B and C under Succinylcholine Chloride.
Bacterial endotoxins 85 It contains not more than 2.0 USP Endotoxin Units per mg of succinylcholine chloride.
pH 791: between 3.0 and 4.5.
Other requirements It meets the requirements under Injections 1.
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 Assay under Succinylcholine Chloride.
Standard preparation Transfer about 88 mg of USP Succinylcholine Chloride RS, accurately weighed, to a 10-mL volumetric flask, add a volume of water to correspond to the solvent composition of the Assay preparation, and dilute with Mobile phase to volume while mixing. Prepare the Standard preparation concurrently with the Assay preparation.
Assay preparation Transfer a volume of Injection, equivalent to about 80 mg of anhydrous succinylcholine chloride, to a 10-mL volumetric flask, and dilute with Mobile phase to volume while mixing.
Procedure Proceed as directed for Procedure in the Assay under Succinylcholine Chloride. Calculate the quantity, in mg, of anhydrous succinylcholine chloride (C14H30Cl2N2O4) in each mL of the Injection taken by the formula:
(10C / V)(rU / rS)in which V is the volume, in mL, of Injection taken.
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USP35NF30 Page 4694