Lenalidomide N-Methyl Impurity

Determination of possible potential genotoxic impurities in lenalidomide drug substance by simple RP-​HPLC method
By Gaddam, Kishore; Kanne, Shanker; Gundala, Trivikram Reddy; Mamilla, Yogeshwar Reddy; Chinna, Gangi Reddy Nallagondu
From Asian Journal of Chemistry (2020), 32(12), 2965-2970
 
Development and validation of stability-​indicating RP-​HPLC method for the estimation of lenalidomide and its impurities in oral solid dosage form
By Prasad, Somana Siva; Mohan, G. V. Krishna; Babu, A. Naga
From Oriental Journal of Chemistry (2019), 35(1), 140-149
 
Simultaneous quantification of lenalidomide, ibrutinib and its active metabolite PCI-​45227 in rat plasma by LC-​MS​/MS: Application to a pharmacokinetic study
By Veeraraghavan, Sridhar; Viswanadha, Srikant; Thappali, Satheeshmanikandan; Govindarajulu, Babu; Vakkalanka, Swaroopkumar; Rangasamy, Manivannan
From Journal of Pharmaceutical and Biomedical Analysis (2015), 107, 151-158

Lenalidomide N-Methyl Impurity is chemically 3-[4-(Methylamino)-1,3-dihydro-1-oxo-2H-isoindol-2-yl]-2,6-piperidinedione. Lenalidomide N-Methyl Impurity is supplied with detailed characterization data compliant with regulatory guideline. Lenalidomide N-Methyl 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 Lenalidomide.

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.