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Tubocurarine Chloride Injection
» Tubocurarine Chloride Injection is a sterile solution of Tubocurarine Chloride in Water for Injection. It contains not less than 93.0 percent and not more than 107.0 percent of the labeled amount of C37H41ClN2O6·HCl·5H2O.
Packaging and storage— Preserve in single-dose or in multiple-dose containers.
A: It responds to Identification test C under Tubocurarine Chloride.
B: The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation.
Angular rotation 781: between +0.32 and +0.48 for each mg of tubocurarine chloride per mL claimed on the label, determined in a suitable polarimeter tube and the observed reading being multiplied by the factor 200/L, in which L is the length, in mm, of the tube.
Bacterial endotoxins 85 It contains not more than 10.0 USP Endotoxin Units per mg of tubocurarine chloride.
pH 791: between 2.5 and 5.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system— Prepare as directed in the Assay under Tubocurarine Chloride.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 15 mg of tubocurarine chloride, to a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C37H41ClN2O6·HCl·5H2O in each mL of the Injection taken by the formula:
50C(rU / rS),
in which C is the concentration, in mg per mL, of USP Tubocurarine Chloride RS in the Standard preparation, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 2226
Phone Number : 1-301-816-8330