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.
Identification
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
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Bacterial endotoxins
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pH
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Osmolarity
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Other requirements
It meets the requirements under Injections
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Assay
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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 2844
Pharmacopeial Forum: Volume No. 29(4) Page 1048
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