Update on Nitrosamines in Drug Substance and Drug Product – Focus on API-derived Nitrosamines
The description, assessment and documentation of impurities in drug substance, excipients, drug product and packaging material are an essential part of the quality and safety of a drug during its life cycle. One of the current hot topics is the assessment of nitrosamine impurities, where tremendous and rapid changes have evolved since the first official calls from regulatory authorities.
This webinar will discuss and present the latest developments and the current status of nitrosamine assessments from a regulatory and industrial point of view and cover the following aspects:
Current status of API-derived nitrosamines: reported API nitrosamines and their AI limits:
Landscape of potential small and drug substance-related nitrosamines in pharmaceuticals
- Nitrosated active pharmaceutical ingredients – where we are today?
- Specific aspects of certain compound classes
- EFPIA guidance paper on specific compound classes
- N-nitrosamine formation in pharmaceutical solid drug products: experimental observations
- Solid-state kinetics of nitrosation using native sources of nitrite
- Impact of N-nitrosamine impurities on clinical drug development
- NDMA formation due to active ingredient degradation and nitrite traces in drug products
The role of excipients
- Quality of excipients and impact on nitrosamine formation
- Variability of nitrite content in excipients
- Reactive impurities in excipients
- Trace aldehydes in solid oral dosage forms as catalysts for nitrosating secondary amines
The role of packaging material
Impact of packaging materials on the nitrosamine formation step in drug products
Duration: 150 minutes
Lecture language: English | Slides: English
...your speaker Dr. Helmut Buschmann...
...your speaker Dr. Norbert Handler...
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- Dr. Helmut Buschmann
RD&C Research, Development & Consulting GmbH - Dr. Norbert Handler
RD&C Research, Development & Consulting GmbH
E-Learning | Streaming in MP4 format (EN)