Pemetrexed EP Impurity A

A stability-​indicating LC-​MS​/MS method optimization for Pemetrexed through design of experiments: Identification and characterization of major oxidative degradation product
By Narenderan, S. T.; Ramesh, J.; Babu, B.; Meyyanathan, S. N.
From Journal of Pharmaceutical and Biomedical Analysis (2020), 183, 113150
 
A new validated stability-​indicating gradient RP-​HPLC method for the determination of pemetrexed disodium and its process related substances
By Hemchand, S.; Babu, R. Ravi Chandra; Annapurna, Mukthinuthalapati Mathrusri
From Journal of Drug Delivery and Therapeutics (2019), 9(3Suppl.), 588-610

Content determination of related impurity-​L-​isomer in Pemetrexed Disodium for injection by HPLC
By Li, Jinhua; Yang, Mei
From Heilongjiang Yiyao (2014), 27(3), 498-500

Pemetrexed EP Impurity A is chemically (2S)-2-[4-[2-(2-Amino-1-methyl-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzamido]pentanedioic acid (as per EP); {4-[2-(2-Amino-1-methyl-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-l-glutamic acid (as per USP). It is also known as N-Methyl Pemetrexed Impurity. Pemetrexed EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Pemetrexed EP Impurity A 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 Pemetrexed.

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.