Date/Time
Date(s) - September 20, 2024
2:00 pm - 5:00 pm
Categories
Pharmaceutical industries faced drug recall due to the presence of the Alkyl Nitrosamines in the year 2018 onwards and many companies adapted methodology to monitor small molecule Nitrosamines like NDMA. In mid2023, Regulatory found that API based complex Nitrosamine drug substance N-Nitroso API impurities are also genotoxic and toxic in nature which also need to be monitored to avoid health risks. They have classified these impurities into CPCA 1 to 5 based on their toxicity level and the number of N-Nitroso API impurities to be monitored raised to >1000 numbers and a new methodology must be developed to monitor during their process.
The Pharmaceutical companies are constantly working to meet the regulatory timeline of risk assessment and eventual testing of the presence of NDSRI in the marketed drug products.
Join us in this webinar to learn about current regulations of nitrosamines and how to meet the challenging limits of detection based on the Acceptable Intake (AI) for NDSRI impurities using modern analytical technology.
🗓️: 20 Sept 2024
🕒: 14:00 (WIB)
📍: Webinar (Click to REGISTER)
Who Should Attend?
This webinar series is suitable for routine analytical chemists and lab managers, drug safety regulators,researchers in drug discovery, and anyone interested in advanced techniques for drug impurities detection.
Key Learning Objectives:
- The challenges to develop methods for complex N-Nitroso API impurities,
- The formation of these impurities due to API (or impurities/degradants) and the presence of the nitrosating agents during synthesis, manufacturing, and storage.
- Understand analytical tools to identify unknown impurities from known sources to address the false positive risk.
- Developing robust method for long term reproducibility to adapt for routine batch testing of the drug.
Presented By:
- Umasankar
Market Development, Sr Manager Waters Corporation