Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
Over the past few decades, the scrutiny applied by EMEA and FDA regulators to extractables and leachables...
Browse Content
Discussion of Feedback Received Directly from FDA on ChemTox
In this webinar, we will share the latest trends in feedback received from the FDA concerning extractables...
Identifying and Mitigating Errors in Organic Extractables and Leachables Screening
The practice of Organic Chromatographic Screening, aimed at discovering, identifying, and (semi-)quantifying organic compounds in extracts from...
ICH Stability Testing and Method Development
Stability testing is an essential component of product development, conducted throughout the entire lifecycle of a biotherapeutic...
The New ISO 10993 – 18 Standard and its Impact on Chemical Characterization of Medical Devices
In response to the heightened focus on chemical characterization outlined in ISO 10993-1:2018, a significant revision of...
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
Medical Device Extractable and Leachables Testing in 2020
The world of physics is grounded in beautiful universal constants that seamlessly integrate into the equations governing...
Chemical Interactions between Leachables and Biopharmaceuticals
In the evaluation of pharmaceutical drug products, leachable compounds are typically assessed primarily for the toxicological risks...