Introduction: Applying a Nitrosamine Reformulation Strategy Without Compromising Bioequivalence A structured Nitrosamine Reformulation Strategy can block nitrosamine formation pathways while […]
Introduction In this NDMA Root Cause Investigation Case Study, we examine a real-world scenario involving an unexpected spike of N-nitrosodimethylamine
Case Study: Root Cause Investigation of Unexpected NDMA Spike in Finished Product Read More »
Introduction Nitrosamine Testing CRO Selection requires detailed scientific evaluation and regulatory awareness. Global authorities continue to update nitrosamine guidance, and
Selecting the Right Nitrosamine Testing CRO: A Technical Due Diligence Checklist Read More »
Introduction: The global pharmaceutical industry is facing strict regulatory control for mutagenic impurities, especially nitrosamines. A strong understanding of NDA
NDA vs ANDA Nitrosamine Data Requirements: What Sponsors Must Submit Read More »
Introduction A comprehensive Nitrosamine Risk Assessment for ANDA Submission requires a structured and scientific evaluation of potential nitrosamine formation pathways.
How to Prepare a Complete Nitrosamine Risk Assessment Report for ANDA Submission Read More »
Introduction Nitrosamine Testing in Stability Studies is no longer limited to initial risk mitigation. It has evolved into an ongoing,
Nitrosamine Testing in Stability Studies: Designing Long-Term Monitoring Programs Read More »
Introduction Nitrosamine Testing for Generic Drugs has become a regulatory-critical and business-sensitive requirement in today’s pharmaceutical industry. Global health authorities
Nitrosamine Testing for Generic Drugs: Selecting the Right CRO Read More »
Introduction: Understanding the Shift Toward Non-Pharmaceutical Nitrosamine Analysis In recent years, Nitrosamines in Food and Cosmetics has become a major focus in chemical safety
The Evolving Landscape of Nitrosamines in Food and Cosmetics Read More »
Summary — Key Insights at a Glance Introduction: Packaging Leachables Nitrosamine E&L—The Critical Link in Pharmaceutical Safety The connection between
Leachables and Extractables (E&L): Linking Packaging to Nitrosamine Contamination Read More »
Introduction In active pharmaceutical ingredient (API) manufacturing, Nitrosamine Solvent Catalyst Mitigation has become one of the most important topics for
Mitigating Nitrosamine Formation from Solvents and Catalysts in API Manufacturing Read More »
