Перейти к содержимому

System Suitability Testing

PharmaCores

0:00 / 0:00

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