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.
Identification—
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.
Other requirements— It meets the requirements under Injections 1.
Assay—
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
1-301-816-8330
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3825
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.