Impurities
Impurities
Trace analysis
Troubleshooting production issues
We offer an express service for troubleshooting undesired impurities in your production. This service includes clarifying the structure of soluble organic impurities using LC- HRMS and GC-MS screening methods. We identify inorganic impurities at our cooperation partners using SEM- EDX or ICP- MS. We also have access to imaging methods such as X-ray microtomography/nanotomography, micro CT and Raman microscopy/imaging.
Structural elucidation
We determine the chemical structure of degradation and synthesis by- products as well as unknown components: Using high- resolution LC-MS measurements we make initial statements on the structure of impurities. To elucidate the complete structure, our LC- SPE trapping system provides the option of gaining minimum quantities for subsequent NMR measurements, which we coordinate in your projects in collaboration with cooperation partners.
Identified substances can then be synthesised in collaboration with cooperation partners or isolated using (semi-)preparative techniques, and then qualified by HWI as a reference standard.
Extractables and leachables
Investigations, as required by regulations, of plastic packaging for extractables and subsequently of medicinal products for leachables are designed by our experienced project management team and conducted in our lab.
For new marketing- authorisation applications or amendment procedures, we assess this data and provide it to you as a report.
We offer:
- Extraction studies: exploratory investigations of primary packaging and/or devices to identify extraction profiles of potential extraction products, including the full identification and toxicological qualification of relevant extraction products
- Confirmatory migration studies of medicinal products as part of stability studies
- Regulatory support, including the creation of specifications and submission of justifications, expert reports and consultation
- Matrix- specific method development and validation to perform leachables studies
