- Analysis of genotoxic and highly potent substances, narcotic agents and chemotherapeutic agents
- Analysis of substances with unknown biological and toxicological effects
- Analysis of contaminants in DS/DP and stability studies
- Preparative isolation of contaminants
At SYNLAB, we distinguish between the following 3 types of analyses:
1. Structure elucidation of unknown by- and degradation products
According to our clients we are the best for structure elucidation. Whether you’re dealing with degradation products, genotoxic impurities, or leachables and extractables: we are very skilled at finding the right structures.
2. Unknown impurities
Contaminants occur not only during early development of medicinal products but also, for example, during stability tests or when changes are made to formulations. There are many different reasons for this: e.g. other synthesis paths, interactions with excipients and packaging materials, polymorphic transitions, etc. If the concentration of a by-product and/or degradation product exceeds a specified limit value, the structure of this impurity must be determined. Structure elucidation is frequently followed by the targeted synthesis of the impurity and its analytical qualification as a reference standard.
3. Genotoxic impurities/leachables & extractables
The regulatory agencies (FDA, EMA) focus especially on genotoxic impurities, and leachables and extractables. Low detection limits in the trace range (ppm, ppb) call for special analytical techniques (LC-Q-ToF-MS) to detect these substances.