Mangafodipir Trisodium Injection
» Mangafodipir Trisodium Injection is a sterile solution of Mangafodipir Trisodium in Water for Injection. It contains not less than 94.0 percent and not more than 106.0 percent of the labeled amount of mangafodipir trisodium (C22H27MnN4Na3O14P2). It may contain stabilizers and buffers. It contains no antimicrobial agents.
Packaging and storage Preserve in single-dose containers of Type I glass. Store at controlled room temperature, with containers on their sides in the original carton.
USP Reference standards 11
USP Endotoxin RS
A: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
B: It meets the requirements of the tests for Manganese 191.
Bacterial endotoxins 85: not more than 0.66 USP Endotoxin Unit per mg of mangafodipir trisodium.
pH 791: between 8.4 and 9.2.
Osmolarity 785: between 244 and 330 mOsmol per kg of water.
Other requirements It meets the requirements under Injections 1.
Phosphate buffer and Mobile phase Proceed as directed in the Assay under Mangafodipir Trisodium.
Standard preparation Prepare a solution of USP Mangafodipir Trisodium RS in water having a known concentration of about 2 mg per mL. Transfer 10.0 mL of this solution to a 50-mL volumetric flask, add 5.0 mL of Phosphate buffer, dilute with water to volume, and mix. [noteStore under nitrogen to avoid excessive exposure to air and light. ]
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 100 mg of mangafodipir trisodium, to a 50-mL volumetric flask, dilute with water to volume, and mix. Transfer 10.0 mL of this solution to a 50-mL volumetric flask, add 5.0 mL of Phosphate buffer, dilute with water to volume, and mix. [noteStore under nitrogen to avoid excessive exposure to air and light. ]
Chromatographic system Prepare as directed in the Assay under Mangafodipir Trisodium. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency is not less than 1000 theoretical plates; and the tailing factor is not more than 2.3.
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 mangafodipir trisodium (C22H27MnN4Na3O14P2) in each mL of the Injection taken by the formula:
250(C/V)(rU / rS)in which C is the concentration, in mg per mL, of USP Mangafodipir Trisodium RS in the Standard preparation; V is the volume, in mL, of Injection taken to prepare the Assay preparation; and rU and rS are the mangafodipir peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3761Pharmacopeial Forum: Volume No. 29(4) Page 1048