Main Article Content
Abstract
Posaconazole is a triazole antifungal drug and used for the treatment of infections caused by fungai. During the process development of posaconazole, the process related impurity deshydroxy posaconazole was identified as a critical impurity along with the final active pharmaceutical ingredient. The present work describes the synthesis and characterization of this deshydroxy posaconazole.
Keywords
Article Details
References
- International Conference on Harmonization (ICH) Guidelines, Q3A (R) Impurities in New Drug Substances, February (2002).
- International Conference on Harmonization (ICH) Guidelines, Impurities in New Drug Products, Q3B (R1) (2006).
- Posanol (Posaconazole) Product Monograph, Merck Canada Inc. (2014).
- Noxafil: EPAR—European Medicines Agency-Europa Annex I Summary of Product Characteristics.
- X. Li, N. Brown and A.S. Chau, J. Antimicrob. Chemother., 53, 74 (2003); http://dx.doi.org/10.1093/jac/dkh027.
- G.M. Keating, Drugs, 65, 1553 (2005); http://dx.doi.org/10.2165/00003495-200565110-00007.
- D.V. Prasad, R.V. Reddy and P. Aparna, Am. J. Anal. Chem., 6, 965 (2015); http://dx.doi.org/10.4236/ajac.2015.612092.
- M. Gharpure, V. Krishna, S.R. Sanikommu, G. Chaudhari, J. Verdia and M.A. Khan, Process for Preparation of Posaconazole and Crystalline Polymorphic Form V of Posaconazole, Patent WO2011158248 A2 (2011).
References
International Conference on Harmonization (ICH) Guidelines, Q3A (R) Impurities in New Drug Substances, February (2002).
International Conference on Harmonization (ICH) Guidelines, Impurities in New Drug Products, Q3B (R1) (2006).
Posanol (Posaconazole) Product Monograph, Merck Canada Inc. (2014).
Noxafil: EPAR—European Medicines Agency-Europa Annex I Summary of Product Characteristics.
X. Li, N. Brown and A.S. Chau, J. Antimicrob. Chemother., 53, 74 (2003); http://dx.doi.org/10.1093/jac/dkh027.
G.M. Keating, Drugs, 65, 1553 (2005); http://dx.doi.org/10.2165/00003495-200565110-00007.
D.V. Prasad, R.V. Reddy and P. Aparna, Am. J. Anal. Chem., 6, 965 (2015); http://dx.doi.org/10.4236/ajac.2015.612092.
M. Gharpure, V. Krishna, S.R. Sanikommu, G. Chaudhari, J. Verdia and M.A. Khan, Process for Preparation of Posaconazole and Crystalline Polymorphic Form V of Posaconazole, Patent WO2011158248 A2 (2011).