Gallamine Triethiodide Injection
» Gallamine Triethiodide Injection is a sterile solution of Gallamine Triethiodide in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of gallamine triethiodide (C30H60I3N3O3).
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light.
Identification Evaporate a volume of Injection, equivalent to not less than 200 mg of gallamine triethiodide, to dryness. Take up the residue in warm alcohol, and pass through fine filter paper. Remove a portion of the filtrate, equivalent to about 100 mg of gallamine triethiodide, and evaporate to dryness: the residue responds to the Identification tests under Gallamine Triethiodide.
Bacterial endotoxins 85 It contains not more than 5.0 USP Endotoxin Units per mg of gallamine triethiodide.
pH 791: between 6.5 and 7.5.
Other requirements It meets the requirements under Injections 1.
Sodium perchlorate buffer, Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Gallamine Triethiodide.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 100 mg of gallamine triethiodide, to a 100-mL volumetric flask, dissolve in and 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 C30H60I3N3O3 in the portion of Injection taken by the formula:
100C(rU / rS)in which C is the concentration, in mg per mL, of USP Gallamine Triethiodide RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 2480