Automated Dissolution Tester Apparatus : Fast, Accurate & 21 CFR Part 11 Compliant Introduction Dissolution testing ensures that tablets and capsules release their APIs at the intended rate. It's crucial for predicting drug performance, regulatory submissions, and batch consistency. As formulations become complex and data integrity expectations rise, automation becomes essential. The Role and Importance of Dissolution Testing Dissolution bridges formulation and efficacy by simulating GI conditions to assess drug availability. Regulatory bodies like the FDA and EMA require dissolution data for: • Product development and approval • Quality control and batch release • Stability studies • Bioequivalence and generics Inadequate dissolution can reduce bioavailability or cause failure. Limitations of Manual Dissolution Testing Precision Issues: Manual sampling requires exact timing; small deviations reduce reproduci...