Nitrosamines & NDSRI's: Analytical method development trends and challenges in Nitrosamines and NDSRI's.
Nitrosamine Drug Substance-Related Impurities (NDSRI's) are a class of impurities that can form in drug substances and products. These impurities are of significant concern due to their potential carcinogenicity. Regulatory bodies, including the FDA, have established guidelines and acceptable intake limits to ensure the safety and efficacy of medications.
NDSRI webinar series is a comprehensive three-part webinar series designed to provide valuable insights into the evolving landscape of analytical methods and regulatory requirements. This series will cover critical topics that are essential for professionals in the field.
Key learnings:
- Understanding Nitrosamine / NDSRI and their impact on drug safety.
- Latest regulatory guidelines and requirements.
- Navigating Nitrosamines with Agilent 21 CFR compliant mass Hunter Software.
- A focus on components in chromatographic challenges, with examples of NDSRI methods.
- Case studies and real-world applications.
- Column and consumable selection and how it influences the analysis.
- Best practice for method optimization, development, and automation.
- and more
Presenter: Dr. Sandeep Choudhary (Product Manager - LC/MS, Agilent Technologies)
Dr. Sandeep Choudharyholds a Ph.D. in Pharmacology from INMAS, DRDO. Since completing his doctorate, he has specialized in the study of genotoxic and mutagenic agents, with a primary focus on analytical and bioavailability/bioequivalence (BABE) studies. He has extensive hands-on experience as an Application Scientist, particularly with LC-MS/MS and QTOF technologies. He is an expert in method development for nitrosamines and NDSRIs, and has authored multiple technical notes and research articles on nitrosamines, published in reputed international journals.
Currently, he serves as a Product Manager, dedicated to providing customers with tailored solutions and expert guidance to enhance their operational efficiency and scientific outcomes.
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: Mr. Ankush Sharma (Regional Marketing Program Manager- APAC (Pharma & Biopharma), Agilent Technologies)
Ankush Sharma is a seasoned professional with over 12 years of extensive experience in sales and marketing across the pharmaceutical and biopharmaceutical sectors. His professional journey commenced with a strong educational foundation, earning a Master's degree in Biotechnology. Building upon this knowledge, he furthered his academic pursuits by obtaining a Master's in Business Administration with a specialization in Sales and Marketing, demonstrating his commitment to blending scientific understanding with strategic business acumen. For the past five years, he has been an integral part of Agilent, serving as the Regional Marketing Program Manager for the India and now Asia-Pacific (APAC) region for Pharma and Biopharma Markets.
