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Nitrosamine Impurities in Pharmaceuticals

N-Nitrosamine impurities have become one of the most critical global challenges in pharmaceutical manufacturing since their discovery in multiple drug products in 2018. This video provides a comprehensive, science-based explanation of the risks, regulations, and testing strategies required to ensure medicine safety. 🔍 What This Video Covers: 1️⃣ What Are N-Nitrosamines? • Why they are classified as probable human carcinogens • Toxicological basis for establishing Acceptable Daily Intake (ADI) limits 2️⃣ Global Regulatory Framework • EMA, FDA, ICH guidance evolution • Carcinogenic Potency Categorization Approach (CPCA) • ADI limits and data-driven regulatory decisions 3️⃣ Mandatory 3-Step Assessment for Manufacturers ✔️ Step 1: Initial risk assessment ✔️ Step 2: Confirmatory testing ✔️ Step 3: Mitigation & control strategy implementation 4️⃣ Sources of Contamination • API synthesis changes • Nitrite-contaminated raw materials & excipients • Packaging material migration • Complex risks from NDSRIs and NDLRIs 5️⃣ Testing & Risk Assessment Tools • LC-MS/MS methods • Nitrosation Assay Procedure (NAP test) • In-silico predictive models 🎯 Purpose of This Video To provide a unified workflow that supports regulatory compliance, ensures robust risk evaluation, and helps safeguard public health against potent genotoxic impurities. Perfect for: Pharma professionals, QC analysts, analytical chemists, regulatory specialists, industry leaders, and students. #NNitrosamines #PharmaQuality #DrugSafety #RegulatoryAffairs #FDA #EMA #ICH #GenotoxicImpurities #LCMSMS #PharmaceuticalAnalysis #NDMA #NDSRI #NDLRI #RiskAssessment #GMPCompliance #PharmaManufacturing #qualitycontrol