System Suitability Testing
PharmaCores
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System Suitability Testing
5 просмотров · 2 дн. назад
PharmaCores
140 подписчиков
5 просмотров · 2 дн. назад
In Episode 20 of "Chromatography Mastery," we look at how to prove your entire HPLC system is fit for use before analyzing a single sample using System Suitability Testing (SST).
⚡ What You'll Learn in This Video:
• Why instrument qualification and method validation aren't enough without a daily SST.
• Calculating and evaluating resolution (Rs) and column efficiency (theoretical plates).
• How to measure peak symmetry (tailing factor) and why poor peak shape ruins accuracy.
• Determining system repeatability (%RSD) based on pharmacopeial limits.
• The strict GMP rules for handling a failed SST or failing bracketing standard.
⏱️ Timestamps:
0:00 - What is System Suitability Testing (SST)?
1:10 - Building a Typical SST Sequence
2:00 - Resolution (Rs): Proving Separation
2:55 - Column Efficiency: The Plate Number (N)
3:35 - Peak Shape: Symmetry & Tailing Factor
4:25 - Precision: System Repeatability & %RSD
5:20 - Sensitivity: Signal-to-Noise Ratio (S/N)
6:10 - Lab Walkthrough: Evaluating a Real SST
7:30 - What to Do When SST Fails (GMP Rules)
⏭️ Next Video (Ep 21):
Integration & Chromatography Data Systems — Subscribe to PharmaCores and follow the "Chromatography Mastery" playlist to learn how to turn your peaks into numbers correctly and compliantly.
#SystemSuitability #HPLC #QualityControl #AnalyticalChemistry #PharmaCores