title: Identification and physicochemical characteristics of temozolomide process-related impurities.
abstract: In this article the crystal structures of the starting material TZ-5 and the key intermediate TZ-6 of temozolomide (TZ-7), an anticancer therapeutic agent, are presented, together with their spectroscopic and thermal characteristics. Both compounds crystallize in the triclinic P-1 space group. X-ray crystallography studies proved that the compound TZ-6 exists as a monohydrate. A complete structural assignment was obtained for the signals in the 1H-, 13C- and 15N-nuclear magnetic resonance spectra and the structures were confirmed by Fourier-Transform infrared and Raman spectroscopy. The article describes the importance of the high purity of TZ-6 during the small-scale plant production of TZ-7 in a desired polymorphic form III with the purity higher than 99.50%, according to an HPLC method.
authors: Pharmaceutical Research Institute (PRI), Warszawa 01-793, Poland. m.laszcz@ifarm.eu.
authors: Marta
authors: M
authors: Łaszcz
authors: Marek
authors: M
authors: Kubiszewski
authors: Lukasz
authors: L
authors: Jedynak
authors: Monika
authors: M
authors: Kaczmarska
authors: Łukasz
authors: Ł
authors: Kaczmarek
authors: Wojciech
authors: W
authors: Łuniewski
authors: Krzysztof
authors: K
authors: Gabarski
authors: Anna
authors: A
authors: Witkowska
authors: Krzysztof
authors: K
authors: Kuziak
authors: Maura
authors: M
authors: Malińska
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000737:chemistry / Q000592:standards; D018360:Crystallography, X-Ray; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000737:chemistry / Q000592:standards; D008958:Models, Molecular; D008968:Molecular Conformation; D019906:Nuclear Magnetic Resonance, Biomolecular; D013059:Spectrum Analysis, Raman; D000077204:Temozolomide; D013816:Thermodynamics
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide