Content uniformity and Blend uniformity by HPLC

In Video 24 of Chromatography Mastery, we look at how to ensure every single tablet contains the exact right amount of active ingredient through Content Uniformity and Blend Uniformity testing by HPLC. ⚡ What You'll Learn in This Video: • The 25 mg / 25% rule that decides between Weight Variation and Content Uniformity. • How to prepare and assay individual tablets using HPLC. • A step-by-step breakdown of the USP 905 Acceptance Value (AV) calculation. • How the k constant and M reference value dictate your pass/fail criteria. • Navigating Stage 1 (10 tablets) and Stage 2 (30 tablets) compliance limits like L1 and L2. • The hidden challenges of powder sampling thieves during Blend Uniformity testing. ⏱️ Timestamps: 0:00 - The Problem: Averages vs. Individual Doses 0:45 - Weight Variation vs. Content Uniformity (The 25mg Rule) 1:35 - How to Test Content Uniformity by HPLC 2:20 - Calculating the Acceptance Value (AV) Formula 3:25 - Lab Walkthrough: Passing a Batch at Stage 1 4:15 - Failing Stage 1 & Moving to Stage 2 5:20 - Blend Uniformity: Testing the Powder Before Compression 6:00 - The Hidden Danger of Sampling Thief Errors ⏭️ Next Video (Ep 25): HPLC Method Development Step by Step — Subscribe to PharmaCores and follow the "Chromatography Mastery" playlist to learn how to build an HPLC method from scratch for an API and its degradants. #ContentUniformity #HPLC #USP905 #QualityControl #PharmaCores