[Specification and Test method in the U.S.Pharmacopoeia]
TEST ITEM | ACCEPTANCE CRITERIA |
DESCRIPTION | WHITE TO OFF-WHITE CRYSTALLINE POWDER |
IDENTIFICATION | INFRARED ABSORPTION |
MELTING RANGE | 185 ~ 200 ℃ |
LOSS ON DRYING | NMT 0.3% |
RESIDUE ON IGNITION | NMT 0.1% |
LIMIT OF Nitrilotriacetic acid | NMT 0.1% |
ORGANIC IMPURITIES | NMT 3.0% |
ASSAY | 97.0 ~ 101.0% |
* Approval of drug manufacturing/marketing CODE : 202001873
[REFERENCE]
1. Nunn A. D. et al. A structure-distribution-relationship approach leading to the development of Tc-99m mebrofenin: an improved cholescintigraphic agent. J. Nucl. Med. 1983, 24, 423-430.
2. Krishnamurthy G. T. et al. Cholescintigraphic measurement of liver function: how is it different from other methods? Eur. J. Nucl. Med. Mol. Imaging 2006, 33, 1103-1106.
3. Bhargava K. K. et al. Adenosine triphosphate-binding cassette subfamily C member 2 is the major transporter of the hepatobiliary imaging agent 99mTc-mebrofenin. J. Nucl. Med. 2009, 50, 1140-1146.