Tubocurarine Chloride Injection
»Tubocurarine Chloride Injection is a sterile solution of Tubocurarine Chloride in Water for Injection.It contains not less than 93.0percent and not more than 107.0percent of the labeled amount of C37H41ClN2O6·HCl·5H2O.
Packaging and storage—
Preserve in single-dose or in multiple-dose containers.
Identification—
B:
The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation.
Angular rotation á781ñ:
between +0.32
and +0.48for each mg of tubocurarine chloride per mLclaimed on the label,determined in a suitable polarimeter tube and the observed reading being multiplied by the factor 200/L,in which Lis the length,in mm,of the tube.
and +0.48for each mg of tubocurarine chloride per mLclaimed on the label,determined in a suitable polarimeter tube and the observed reading being multiplied by the factor 200/L,in which Lis the length,in mm,of the tube.
Bacterial endotoxins á85ñ—
It contains not more than 10.0USP Endotoxin Units per mg of tubocurarine chloride.
pHá791ñ:
between 2.5and 5.0.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard preparation,System suitability preparation,and Chromatographic system—
Prepare as directed in the Assayunder Tubocurarine Chloride.
Assay preparation—
Transfer an accurately measured volume of Injection,equivalent to about 15mg of tubocurarine chloride,to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure—
Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C37H41ClN2O6·HCl·5H2Oin each mLof the Injection taken by the formula:
50C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Tubocurarine Chloride RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 2001
Phone Number:1-301-816-8330