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Thesis topic proposal
 
Viola Horváth
Analysis of genotoxic/mutagenic impurities in pharmaceuticals by LC-MS

THESIS TOPIC PROPOSAL

Institute: Budapest University of Technology and Economics
chemistry
George A. Olah Doctoral School of Chemistry and Chemical Technology

Thesis supervisor: Viola Horváth
belső konzulens: Imre Kapui
Location of studies (in Hungarian): BME Department of Inorganic and Analytical Chemistry
Abbreviation of location of studies: BME


Description of the research topic:

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.

Number of students who can be accepted: 1

Deadline for application: 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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