Metabolite M1 Impurity

Stability indicative and cost effective creation and validation of analytical method of Lopinavir and Rilpivirine by high performance liquid chromatography
By Srinivas, L.; Jain, Neelu
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2021), 12(1), 786-792
 
Analytical methods development & validation for simultaneous estimation of lopinavir & ritonavir in pharmaceutical formulation by simultaneous equation method using UV spectrophotometry
By Jadhav, Sarika R.; Alhat, Hemant P.; Joshi, Suhas
From International Research Journal of Pharmacy (2018), 9(8), 57-62
 
Development and validation of forced degradation studies of lopinavir using RP-​HPLC and characterization of degradants by LC-​MS​/MS
By Bhavyasri, Khagga; Balaram, V. Murali; Nageswarao, R.; Rambabu, D.; Ajitha, M.
From International Journal of Chemical Sciences (2015), 13(1), 551-562

Metabolite M1 Impurity is chemically (S)-N-((2S,4S,5S)-5-(2-(2,6-dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-2-(2,4-dioxotetrahydropyrimidin-1(2H)-yl)-3-methylbutanamide. It is also known as Lopinavir 4-Oxo Analog . Metabolite M1 Impurity is supplied with detailed characterization data compliant with regulatory guideline. Metabolite M1 Impurity 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 Lopinavir.

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.