Methotrexate EP Impurity I

Identification and Quantitation of Impurities in Methotrexate
dulal c. chatterji, altice g. frazier, and joseph f. gallell
Journal of Pharmaceutical Sciences Volume 67, Issue 5, May 1978, Pages 622-624
 
determination of methotrexate and its major metabolite, 7_hydroxymethotrexate, using capillary zone electrophoresis and laser-induced fluorescence detection
mark c. roach, philippe gozel and richard n. zare
Journal of Chromatography, 426 (1988) 129-140
 
Analytical methodologies for determination of methotrexate and its metabolites in pharmaceutical, biological and environmental samples
Forough Karami , Sara Ranjbar  , Younes Ghasemi , Manica Negahdaripour
Journal of Pharmaceutical Analysis 9 (2019) 373-391
 
Perspectives of Methotrexate-Based Radioagents for Application in Nuclear Medicine
Paweł Krzysztof Halik,* Przemysław Kozmin ́ ski, and Ewa Gniazdowska
Mol. Pharmaceutics 2021, 18, 1, 33–43
 

Methotrexate EP Impurity I is chemically (4S)-4-[[4-[[(2,4-diaminopteridin-6-yl)methyl]methylamino]benzoyl]amino]-5-methoxy-5-oxopentanoic acid (as per EP) ; (S)-4-(4-{[(2,4-Diaminopteridin-6-yl)methyl](methyl)amino}benzamido)-5-methoxy-5-oxopentanoic acid (as per USP). It is also known as Methotrexate USP Related Compound I ; Methotrexate 1-Methyl Ester (EP). Methotrexate EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Methotrexate EP Impurity I 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 Methotrexate.

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.