title: Synthesis and physicochemical characterization of the impurities of pemetrexed disodium, an anticancer drug.
abstract: A physicochemical characterization of the process-related impurities associated with the synthesis of pemetrexed disodium was performed. The possibility of pemetrexed impurities forming has been mentioned in literature, but no study on their structure has been published yet. This paper describes the development of the synthesis methods for these compounds and discusses their structure elucidation on the basis of two-dimensional NMR experiments and MS data. The identification of these impurities should be useful for the quality control during the production of the pemetrexed disodium salt.
authors.affiliation: Pharmaceutical Research Institute, 8 Rydygiera Street, 01-793 Warsaw, Poland. o.michalak@ifarm.eu.
authors.forename: Olga
authors.initials: O
authors.lastname: Michalak
authors.affiliation: Pharmaceutical Research Institute, 8 Rydygiera Street, 01-793 Warsaw, Poland. m.gruza@ifarm.eu.
authors.forename: Mariusz M
authors.initials: MM
authors.lastname: Gruza
authors.affiliation: Pharmaceutical Research Institute, 8 Rydygiera Street, 01-793 Warsaw, Poland. a.witkowska@ifarm.eu.
authors.forename: Anna
authors.initials: A
authors.lastname: Witkowska
authors.affiliation: Pharmaceutical Research Institute, 8 Rydygiera Street, 01-793 Warsaw, Poland. i.bujak@ifarm.eu.
authors.forename: Iwona
authors.initials: I
authors.lastname: Bujak
authors.affiliation: Pharmaceutical Research Institute, 8 Rydygiera Street, 01-793 Warsaw, Poland. piotr.cmoch@icho.edu.pl.|Institute of Organic Chemistry, Polish Academy of Sciences, 44/52 Kasprzaka Street, 01-224 Warsaw, Poland. piotr.cmoch@icho.edu.pl.
authors.forename: Piotr
authors.initials: P
authors.lastname: Cmoch
mesh_terms: D000970:Antineoplastic Agents / Q000138:chemical synthesis* / Q000737:chemistry; D004151:Dipeptides / Q000737:chemistry / Q000302:isolation & purification; D004791:Enzyme Inhibitors / Q000138:chemical synthesis* / Q000737:chemistry; D005559:Formamides / Q000737:chemistry / Q000302:isolation & purification; D006801:Humans; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D000068437:Pemetrexed / Q000138:chemical synthesis* / Q000737:chemistry; D011786:Quality Control; D013237:Stereoisomerism
chemical_list: D000970:Antineoplastic Agents; D004151:Dipeptides; D004791:Enzyme Inhibitors; D005559:Formamides; D000068437:Pemetrexed
keywords: NMR; diastereoisomers; impurities; pemetrexed