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: The Role of Secondary Amine Scavenger Nitrosamine in Drug Product Stability The use of Secondary Amine Scavenger Nitrosamine control
Secondary Amine Scavenging Strategies and the Impact on Drug Product Stability Read More »
Summary Introduction: Why Advanced Nitrosamine Purge Factor Calculation Is the Regulatory Game-Changer In today’s pharmaceutical impurity control landscape, Nitrosamine Purge
Advanced Purge Calculation Methodologies and Regulatory Acceptance Read More »
Summary (Key Takeaways) Introduction: The Overlooked Role of Excipients in Nitrosamine Risk For many years, the pharmaceutical industry focused mainly
Identifying and Controlling Excipient Contamination as a Nitrosamine Source Read More »
Introduction: The Nexus Between Nitrosamine AI Limit and CPCA Category The connection between the Nitrosamine AI limit and CPCA category
The Role of Acceptable Intake (AI) Limit Derivation and CPCA Category Assignment Read More »
Introduction Less-Than-Lifetime (LTL) Exposure Calculations for Nitrosamines are a critical toxicological tool used when patient exposure to nitrosamine impurities occurs
Less-Than-Lifetime (LTL) Exposure Calculations for Nitrosamines: When and How to Apply Read More »
Introduction Isomeric Nitrosamines Analysis is considered one of the most demanding areas in pharmaceutical quality control and environmental testing. These
Solving Chromatographic Challenges for Isomeric Nitrosamines Read More »
Introduction Achieving Ultra-Low Limit of Quantitation (LOQ) in Nitrosamine Testing requires a well-coordinated combination of analytical precision, instrument optimization, and
Strategies for Achieving Ultra-Low Limit of Quantitation (LOQ) in Nitrosamine Analysis Read More »
Introduction Pharmaceutical quality standards continue to rise, requiring analytical techniques that can detect impurities at extremely low levels. HRMS for
Summary Introduction: GC-MS Method Development for Nitrosamine Testing GC-MS Method Development for Nitrosamine Testing is critical for protecting patient safety,
Advanced GC-MS/MS Method Development for Volatile Nitrosamines (e.g., NDMA, NDEA) Read More »
