témavezető: Horváth Viola
belső konzulens: Kapui Imre
helyszín (magyar oldal): BME Szervetlen és Analitikai Kémia Tanszék helyszín rövidítés: BME
A kutatási téma leírása:
The quality of active pharmaceutical ingredients and preparations is of paramount importance, and regulatory requirements ensure that medicines are free from toxic contaminants. The requirements are constantly tightening. Whereas previously it was sufficient to control organic impurities at 0.1% level, the limits for genotoxic/mutagenic impurities are now in the ppm range and the latest regulations established the limits for certain nitrosamines in the ppb range. To measure such low concentration levels, hyphenated techniques (GC-MS or HPLC-MS) are required. The PhD work focuses on the analytical investigation of genotoxic/mutagenic impurities, including the development and validation of novel HPLC-MS/MS-based analytical methods and understanding the mechanisms of impurity formation. The main focus of the thesis is a small group of genotoxic contaminants, nitrosamines. Nitrosamines are "cohort of concern" compounds according to the ICH M7 guideline, as they are considered to be very potent mutagens/carcinogens with very low limits in formulations. Therefore, their testing requires new, innovative methods, which will also help to understand the mechanism of their formation.
felvehető hallgatók száma: 1
Jelentkezési határidő: 2024-05-30
2024. IV. 17. ODT ülés Az ODT következő ülésére 2024. június 14-én, pénteken 10.00 órakor kerül sor a Semmelweis Egyetem Szenátusi termében (Bp. Üllői út 26. I. emelet).
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