Q. What is dissolution testing, and why is it important? Dissolution testing is a critical quality control measure in pharmaceutical manufacturing that evaluates how quickly an active pharmaceutical ingredient (API) releases from its dosage form. It ensures product efficacy, consistency, and patient safety. Q. What are the stages of dissolution testing? Dissolution testing occurs in…
Q. What is USP Apparatus 1? USP Apparatus 1 refers to baskets, which were the first standardized apparatus added to the USP. Q. How common is the use of baskets in dissolution testing? Baskets are the second most common apparatus used in methods today due to their versatility for various dosage forms. Q. When should…
The dissolution medium contains a surfactant, like sodium lauryl sulfate (SLS) or Tween 80. The test begins smoothly, but soon enough, foam starts building up—slowly at first, then rising relentlessly. Before you know it, there’s foam all over the place, making sampling impossible and throwing your entire test off balance. Frustrating, right? The “Eureka” Moment!…
A logical five-step approach mentioned below for dissolution method development: 1. Conduct a Solubility TestBegin by assessing the solubility of the product’s maximum daily dose in various media. This establishes a foundational understanding of the product’s solubility profile. 2. Select Dissolution MediaBased on the solubility data, determine the appropriate dissolution media volume and pH. Ensure…