Mitigating Risk of Mutagenic Impurities – A comprehensive approach to analyze trace level Nitrosamines.
The presence of impurities in pharmaceutical products may influence their efficacy and safety even in very small amounts. Recent regulatory focus on complex mutagenic impurities and nitrosamines, has led manufacturers to complete risk assessment using modern analytical techniques like LC/MS, GC/MS. Ultrapure water quality & it’s monitoring also plays a very critical role to achieve reproducible results in modern analytical techniques.
Many companies had to suffer product recalls due to the presence of such impurities, and a risk mitigation plan needs to be implemented to comply with latest regulatory requirements and assure product quality.
Agilent has been at the forefront of nitrosamine analysis and Milli-Q® Lab Water Solutions from Merck, a pioneer in lab water purification technology brings its renowned expertise to answer the toughest questions on this subject:
- Regulatory landscape for nitrosamines in drug substances and drug products.
- LC-MS workflow for nitrosamine analysis: sensitivity and method ruggedness, case studies on LC-QQQ and LC-QToF
- Impact of contaminants in water on the test results
- Optimum water quality for trace-level organic analysis & how to achieve it
- Methods for Metformin Combination drugs
Who should attend:
- Pharma Lab managers and analysts working on analytical development, QC and R&D departments with interest in E&L studies and/or nitrosamine analysis
- Analytical lab managers in CRO´s/CDMO´s/CMO´s/CTLs
- Researchers interested in E&L testing and nitrosamine testing in Pharma Products
- Quality Assurance managers
Presenter: Chander Mani (Application Engineer - LCMS, Agilent Technologies)
Presenter: Vinita Singh (Senior Product Manager, Lab Water Solutions – India & Singapore, Merck Life Science)
