Method for testing radiochemical purity of Tc-99m-TRODAT-1

Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant... – In an organic compound

Reexamination Certificate

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C424S001110

Reexamination Certificate

active

07943117

ABSTRACT:
The present invention is to invent a novel method for testing the radiochemical purity of Tc-99m-TRODAT-1 through a high performance liquid chromatography on a widely available C-18 column.

REFERENCES:
patent: 5690904 (1997-11-01), MacWhorter et al.
patent: 6241963 (2001-06-01), Kung et al.
patent: 7597875 (2009-10-01), Archer et al.
Shabir, G. “HPLC Method Development and Validation for Pharmaceutical Analysis,” PharmTec.com, Mar. 2004.
Snyder et al., Practical HPLC Method Development, 1997.
Luyt et al., Bioconjugate Chem., 1999, 10, p. 470-479.
Center for Drug Evaluation and Research, Reviewer Guidance Validation of Chromatographic Methods, 1994, p. 1-29.

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