Tadalafil EP Impurity D

Quantification of Genotoxic Impurities in Tadalafil by Simple and Sensitive Gas Chromatography Technique
Ajit Anerao,Bhushan Patil,Vishal Solse &Chandrakant Patil
Analytical Chemistry Letters Volume 9, 2019 - Issue 4 Pages 518-525
 
Chiral Separation of Two Pairs of Enantiomers of Tadalafil by High-Performance Liquid Chromatography
Wenhui Gao, Zhefeng Zhang, Zhiwei Li, and Guijian Liang
Journal of Chromatographic Science, Vol. 45, September 2007
 
Fast ultra‐high‐performance liquid chromatography with diode array and mass spectrometry method for determination of tadalafil drug substance and its impurities
Ludovit Schreiber  Radoslav Halko  Milan Hutta
Biomedical Chromatography Volume31, Issue12 December 2017 e4020
 
Validation and stability indicating RP-HPLC method for the determination of tadalafil API in pharmaceutical formulations
B. Prasanna Reddy , K. Amarnadh Reddy  and M. S. Reddy
Research In Pharmaceutical Biotechnology Vol. 2(1), pp. 001-006
 
Stability-indicating methods for determination of tadalafil in presence of its degradation product
Moataz A.Yehia*, Mamdouh R.Rezk, Mohamed A.El-Sayed, Mohamed Abdel Kawy
ACAIJ, 14(9) 2014 [351-362]

Tadalafil EP Impurity D is chemically (6bR)-12-(1,3-Benzodioxol-5-yl)-12a-hydroxy-8-methyl- 6a,6b,8,9,12,12a-hexahydropyrazino[1′,2′:1,2]pyrrolo[3,4-c]quinoline-6,7,10(5H)-trione (as per EP). Tadalafil EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Tadalafil EP Impurity D 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 Tadalafil.

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.