Daclatasvir Impurity 2

A validated stability-​indicating reverse-​phase high-​performance liquid chromatography method for daclatasvir, identification and characterization of degradation products using LC-​ESI-​QTOF-​MS
By Warghade, Snehal V.; Bothara, Kailash G.
From Asian Journal of Pharmaceutical and Clinical Research (2019), 12(5), 302-308
 
Development and validation of HPLC fluorescence and UPLC​/DAD stability-​indicating methods for determination of hepatitis C antiviral agent daclatasvir
By Kamal, Andra H.; Ismail, Nahla S.; Mabroijk, Mokhtar M.; Bebawy, Lories I.; Mekky, Mai A.
From Journal of AOAC International (2019), 102(4), 1125-1131
 
A stability-​indicating UPLC method for the determination of potential impurities and its mass by a new QDa mass detector in daclatasvir drug used to treat hepatitis C infection
By Jagadabi, Varaprasad; Kumar, P. V. Nagendra; Mahesh, Kasthuri; Pamidi, Srinivasu; Ramaprasad, L. A.; Nagaraju, D.
From Journal of Chromatographic Science (2019), 57(1), 44-53
 

Daclatasvir Impurity 2 is chemically (Tert-butoxycarbonyl)-L-proline. Daclatasvir Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Daclatasvir Impurity 2 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 Daclatasvir.

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.