Are you grappling with nitrosamine risk assessments for your pharmaceutical products? With regulatory agencies demanding increasingly stringent testing and documentation, having effective control strategies is no longer optional—it’s essential for compliance and patient safety.
Our comprehensive white paper delves into the complex world of nitrosamine impurity control in active pharmaceutical ingredients (APIs) and drug products, covering:
- Regulatory perspective: Understanding the FDA and EMA guidance on acceptable intake limits and testing requirements
- Analytical methodologies: Comparing GC-MS and LC-MS/MS platform methods with practical sensitivity data
- NDSRI strategies: Approaches for identifying and quantifying Nitrosamine Drug Substance Related Impurities
- Real-world applications: Seven detailed case studies demonstrating solutions to common challenges
Critical August 2025 Deadline: The FDA requires conclusion of NDSRI confirmatory testing of drug products and submission of all required changes in drug applications by August 1, 2025. This white paper provides essential guidance to help you meet this important regulatory milestone with proven methodologies for nitrosamine control.
Download now to enhance your nitrosamine control program and ensure your organization is prepared for the upcoming NDSRI regulations with insights from industry experts.