raiselabequipment

Dissolution testing plays a vital role in evaluating the performance of oral solid dosage forms, particularly tablets and capsules. It provides critical data about the rate and extent to which the active pharmaceutical ingredient (API) is released into a solution. This article outlines the key steps involved in the calibration and validation process, ensuring your pharmaceutical testing practices are compliant, consistent, and credible. Importance of Calibration and Validation Calibration and validation of a dissolution tester ensure that the equipment performs within specified limits and provides accurate, reproducible results. Regulatory agencies such as the FDA and USP (United States Pharmacopeia) mandate strict compliance with calibration and validation procedures. Inaccurate dissolution results can lead to regulatory issues, product recalls, and compromised patient safety.   Read More