Introduction: Why Nitrosamine Testing Highly Potent APIs Requires Specialized Expertise Nitrosamine Testing Highly Potent APIs demands highly sensitive analytical methods, […]
Nitrosamine Testing in Controlled Substances and Highly Potent APIs (HPAPIs) Read More »
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 »
