Dissolution is a key testing process in the pharmaceutical industry that measures how quickly a medication (usually a tablet or capsule) breaks down and releases its active ingredients in conditions similar to the human body. Think of it like testing how fast a sugar cube would dissolve in water, but for medicines. This testing is crucial for ensuring that medications will work properly when patients take them. Companies use dissolution testing to check the quality of their products, meet regulatory requirements from agencies like the FDA, and develop new medications. It's a fundamental skill in pharmaceutical quality control and drug development.
Conducted Dissolution testing for over 200 product batches annually
Led method development for Dissolution and Dissolution Profile studies of new generic products
Supervised Dissolution Testing protocols and trained junior analysts in Dissolution techniques
Typical job title: "Dissolution Analysts"
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Q: How would you handle an out-of-specification dissolution result?
Expected Answer: A senior analyst should explain the investigation process, including checking equipment calibration, retesting procedures, documentation requirements, and the steps for root cause analysis. They should mention regulatory requirements and corrective actions.
Q: Describe your experience with method development for dissolution testing.
Expected Answer: Should discuss experience in creating and validating new testing methods, choosing appropriate dissolution media, understanding different apparatus types, and working with regulatory guidelines.
Q: What factors can affect dissolution test results?
Expected Answer: Should mention factors like temperature control, proper deaeration of media, paddle speed, tablet positioning, and proper sampling techniques. Should understand basic troubleshooting.
Q: Explain the difference between immediate release and extended release dissolution testing.
Expected Answer: Should explain how testing parameters and time points differ for these formulations, and why different approaches are needed for different drug release patterns.
Q: What are the basic components of a dissolution apparatus?
Expected Answer: Should be able to describe the basic parts like vessels, paddles/baskets, temperature control, and sampling points. Should understand basic operation and maintenance.
Q: Why is dissolution testing important in pharmaceutical analysis?
Expected Answer: Should explain that dissolution testing helps predict how drugs will behave in the body and ensures consistent quality between different batches of medicines.