Dabigatran Impurity 8

Novel method for separation and quantification of potential impurities by RP-​HPLC from KSM stage to API stage of dabigatran mesylate
By Jhansi, T. Naga; Nagaraju, R.; Kumar, D. Jaya Deep; Rao, G. Nageswara
From International Journal of Pharmaceutical Sciences and Research (2021), 12(3), 1762-1779
 
Development and Validation of RP-​UPLC Method for the Determination of Process and Degradant Impurities Present in Dabigatran Etexilate Mesylate Capsules Using High Strength Silica-​T3 Sorbent Column
By Mantena, Bhaskara P. V.; Rao, Sumathi V.; Suryakala, D.; Ramakrishna, K.; Srikanth Reddy, R.
From Analytical Chemistry Letters (2016), 6(5), 595-611
 
Determination of dabigatran etexilate mesylate by HPLC
By Jia, Ling-xiao; Tang, Lei; Zhang, Shu-ting; Song, Rui-zhi; Gao, Zhan-wen
From Shipin Yu Yaopin (2015), 17(3), 195-197

Dabigatran Impurity 8 is chemically Ethyl 3-(4-(methylamino)-3-nitro-N-(pyridin-2-yl)benzamido)propanoate. Dabigatran Impurity 8 is supplied with detailed characterization data compliant with regulatory guideline. Dabigatran Impurity 8 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 Dabigatran.

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.