Ritonavir EP Impurity U

Development and validation of stability-​indicating UPLC-​TUV method for simultaneous estimation of darunavir and ritonavir in bulk and tablet dosage form
By Kamalakannan, Dhanabalan; AnandaThangadurai, Subramaniam
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2021), 12(1), 611-619
 
Stability indicating method development and validation for simultaneous estimation of Lopinavir and Ritonavir by using RP-​HPLC
By Raghu, P. S.
From World Journal of Pharmaceutical Research (2018), 7(3), 1750-1757
 
Stability-​indicating RP-​HPLC method for simultaneous quantification of ombitasvir, paritaprevir and ritonavir in tablet dosage form
By Kuna, Mangamma; Dannana, Gowri Sankar
From Asian Journal of Chemistry (2018), 30(6), 1277-1283
 

Ritonavir EP Impurity U is chemically (1S,3S)-3-[[(2S)-3-methyl-2-[[methyl[[2-(1-methylethyl)thiazol-4-yl]methyl]carbamoyl]amino]butanoyl]amino]-4-phenyl-1-[(1S)-2-phenyl-1-[[(thiazol-5-ylmethoxy)carbonyl]amino]ethyl]butyl (2S)-3-methyl-2-[[methyl[[2-(1-methylethyl)thiazol-4-yl]methyl]carbamoyl]amino]butanoate (as per EP); (S)-[(5S,8S,10S,11S)-8,11-Dibenzyl-5-isopropyl-1-(2-isopropylthiazol-4-yl)-2-methyl-3,6,13-trioxo-15-(thiazol-5-yl)-14-oxa-2,4,7,12-tetraazapentadecan-10-yl] 2-{3-[(2-isopropylthiazol-4-yl)methyl]-3-methylureido}-3-methylbutanoate (as per USP). It is also known as O-Acyl Ritonavir (USP). Ritonavir EP Impurity U is supplied with detailed characterization data compliant with regulatory guideline. Ritonavir EP Impurity U 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 Ritonavir.

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.