Precision Under Pressure: Understanding Method Development Strategies for Nitrosamines & NDSRI's
A 3-part webinar series to help you stay ahead in nitrosamines & NDSRI analysis, from regulatory clarity to method mastery and compliance confidence.
Session 2: Precision Under Pressure: Understanding Method Development Strategies for Nitrosamines & NDSRI's
The rising regulatory scrutiny around nitrosamines and NDSRIs demands a robust and scientifically sound analytical approach. This session aims to provide a comprehensive overview of method development strategies tailored for the detection and quantification of both conventional nitrosamines and complex NDSRIs using LC-TQ platforms. It will also provide guidance on choosing the right chemistries and consumables tailored for high-throughput and high-confidence analysis.
Key Takeaways:
- LC/TQ and LC/QTOF-based sensitive and selective method development for nitrosamines and NDSRIs - emphasizing precision, reproducibility, and regulatory compliance
- Formulation-specific method optimization tips - practical insights and best practices for adapting NDSRI detection methods across diverse dosage forms, highlighting how excipients, matrix complexity, and formulation type influence method parameters and optimization strategies
- Integrated workflow solutions from sample prep to data interpretation
- Selecting the right columns for critical separation and high mass load
- Key consumables to enhance chromatography and ease of use
- Common method development challenges and troubleshooting solutions
- Interactive Q&A with Agilent experts
Presenter: Ms. Preeti Bharatiya (Application Engineer - LC-MS/MS, Agilent Technologies)
As an Application Engineer for LC-MS/MS at Agilent India, she specializes in supporting Pharma workflows. With a background as a Pharmacist and an MS in Pharmaceutical Sciences from NIPER, she has significant experience in the pharmaceutical application area of LC-MS/MS. Her expertise lies in drug impurity analysis, specifically in Nitrosamines quantitation using UHPLC-Triple Quadrupole as a platform. She also has experience in the pre-clinical drug development phase, including pharmacokinetic and toxicokinetic studies, drug tissue distribution studies, and rapid-automated sample preparation for biological matrices.
Presenter: Dr. Sunil B Lakhmapure (Technical Support Specialist, Agilent Technologies)
Sunil holds 19 year plus experience in the analytical field with major exposure to LC/GC with Single Quad, Triple Quad and high resolution (QToF) mass spectroscopy. Started career in Pharma R&D as a scientist with hands on experience on high end instruments like LC/MS, XRD & NMR. Developed & published application notes using Chromatographic techniques on real world samples/issues at various levels.
