Posaconazole 1-oxido impurity + Posaconazole 4-oxido impurity

Influence of cyclodextrin on posaconazole stability, release and activity: Improve the utility of the drug
By Santana, Ana Cristina Sousa Gramoza Vilarinho; Nadvorny, Daniela; da Rocha Passos, Taisa Daiany; de La Roca Soares, Monica Felts; Soares-Sobrinho, Jose Lamartine
From Journal of Drug Delivery Science and Technology (2019), 53, 101153
 
Stability-​indicating HPLC method development and structural elucidation of novel degradation products in posaconazole injection by LC-​TOF​/MS, LC-​MS​/MS and NMR
By Yang, Yidi; Zhu, Xi; Zhang, Fei; Li, Wei; Wu, Ying; Ding, Li
From Journal of Pharmaceutical and Biomedical Analysis (2016), 125, 165-177
 
Stability indicating HPLC method for the quantification of posaconazole and its related substances
By Govind, Sampath Kumar Reddy; Nagaraju, Ch. V. S.; Rajan, S. T.; Eshwaraiah, S.; Kishore, M.; Rakesh, M.; Chakravarthy, I. E.
From Pharma Chemica (2014), 6(1), 486-494, 9 pp..
 

Posaconazole 1-oxido impurity + Posaconazole 4-oxido impurity is chemically 1-(4-(((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)-4-(4-(1-((2S,3S)-2-hydroxypentan-3-yl)-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl)phenyl)piperazine 1-oxide 4-(4-(((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)-1-(4-(1-((2S,3S)-2-hydroxypentan-3-yl)-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl)phenyl)piperazine 1-oxide 2,2,2-trifluoroacetate. Posaconazole 1-oxido impurity + Posaconazole 4-oxido impurity is supplied with detailed characterization data compliant with regulatory guideline. Posaconazole 1-oxido impurity + Posaconazole 4-oxido impurity can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Posaconazole.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.