🌟 Session Summary: Analytical Method Validation & Transfer
Автор: NAGESH PATIL
Загружено: 2026-01-08
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🌟 Session Summary: Analytical Method Validation & Transfer
🔬 Analytical Method Validation (ICH Q2R2)
🎯 Specificity – Distinguish analyte from impurities.
📏 Linearity/Range – Response proportional (e.g., 50–150%).
🎯 Accuracy – Recovery of spiked impurities.
📊 Precision – Repeatability & intermediate precision.
⏱ LOD/LOQ – Sensitivity levels (e.g., 0.02%, 0.05%).
🧪 Robustness – Small deliberate variations.
📡 System Suitability – Resolution, %RSD checks.
📚 USP 1226 Method Verification
Confirms compendial method suitability.
Key checks: Accuracy, Precision, Specificity, LOD/LOQ, Range.
✔️ Only verification needed, not full validation.
🔄 Analytical Method Transfer (AMT)
Ensures reproducibility in receiving lab.
Approaches: 📦 Comparative testing | 📄 Co-validation | 🔍 Verification.
Protocol: Objective, samples, replicates, acceptance criteria, documentation.
✅ Regulatory References
ICH Q2R2, USP 1225, USP 1226, FDA, EMA, WHO.
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