Efinaconazole Impurity 15

RP-HPLC-UV method development andvalidation for simultaneous determinationof terbutaline sulphate, ambroxol HCl andguaifenesin in pure and dosage forms
N. Itagimatha, D.H. Manjunatha
Annales Pharmaceutiques Françaises Volume 77, Issue 4, July 2019, Pages 295-301
 
A Facile Epoxide Aminolysis Promoted by (t-BuO)2Mg and Its Application to the Synthesis of Efinaconazole
Fuqiang Zhu, Yuanchao Xie, Jian Zhang, Guanghui Tian, Hongjian Qin, Xiaojun Yang, Tianwen Hu, Yang He, Haji Akber Aisa, and Jingshan Shen
Org. Process Res. Dev. 2018, 22, 5, 625–632

Efinaconazole Impurity 15 is chemically (2R,3R)-3-((1H-1,2,4-Triazol-1-yl)methyl)-6-fluoro-3-hydroxy-2-methyl-4'-methylenespiro[indoline-1,1'-piperidin]-1-ium fluoride. Efinaconazole Impurity 15 is supplied with detailed characterization data compliant with regulatory guideline. Efinaconazole Impurity 15 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 Efinaconazole.

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.