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Identification, Synthesis and Characterization of Impurities of (S)-Mitiglinide Calcium Dihydrate
Corresponding Author(s) : T. Umasankara Sastry
Asian Journal of Chemistry,
Vol. 26 No. 8 (2014): Vol 26 Issue 8
Abstract
(S)-Mitiglinide Calcium dihydrate (1), an important potent hypoglycemic agent. During laboratory optimization and later in bulk synthesis the formation of various impurities was observed. The method of preparation of most of these impurities is not available in literature. We describe herein the formation, synthesis, preparation and characterization of these impurities.
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- L.A. Sorbera, P.A. Leeson, R.M. Castaner and J. Castaner, Drugs Future, 25, 1034 (2000); doi:10.1358/dof.2000.025.10.598279.
- J. Liu, Y. Yang and R. Ji, Chemica Acta, 87, 1935 (2004); doi:10.1002/hlca.200490174.
- J. Liu, Y. Yang and R. Ji, Synth. Commun., 34, 2633 (2004); doi:10.1081/SCC-200025625.
- T. Yamaguchi, T. Yanagi, H. Hokari, Y. Mukaiyama, T. Kamijo and I. Yamamoto, Chem. Pharm. Bull. (Tokyo), 45, 1518 (1997); doi:10.1248/cpb.45.1518.
- L. Liu, Chinese Patent 102101838 (2010).
- G. Su and Y. Chai, Chinese Patent 1324010 (2005).
- ICH guidelines, Q3A (R): Impurities in New Drug Products: The Quality Guidelines for Active Pharmaceutical Ingredients Related to Impurities According to the International Conference of Harmonization (2002); http://www.ich.org.
- C. Ju, Z. Wang, C. Lin and Q. Jiang, Chinese Patent 101973926 (2010).
- J.P. Lecouve, C. Fugier and J.-C. Souvie, US Patent 6133454 (2000).
References
L.A. Sorbera, P.A. Leeson, R.M. Castaner and J. Castaner, Drugs Future, 25, 1034 (2000); doi:10.1358/dof.2000.025.10.598279.
J. Liu, Y. Yang and R. Ji, Chemica Acta, 87, 1935 (2004); doi:10.1002/hlca.200490174.
J. Liu, Y. Yang and R. Ji, Synth. Commun., 34, 2633 (2004); doi:10.1081/SCC-200025625.
T. Yamaguchi, T. Yanagi, H. Hokari, Y. Mukaiyama, T. Kamijo and I. Yamamoto, Chem. Pharm. Bull. (Tokyo), 45, 1518 (1997); doi:10.1248/cpb.45.1518.
L. Liu, Chinese Patent 102101838 (2010).
G. Su and Y. Chai, Chinese Patent 1324010 (2005).
ICH guidelines, Q3A (R): Impurities in New Drug Products: The Quality Guidelines for Active Pharmaceutical Ingredients Related to Impurities According to the International Conference of Harmonization (2002); http://www.ich.org.
C. Ju, Z. Wang, C. Lin and Q. Jiang, Chinese Patent 101973926 (2010).
J.P. Lecouve, C. Fugier and J.-C. Souvie, US Patent 6133454 (2000).