Sample interview questions: Can you discuss your experience with developing and implementing stability-indicating assays for pharmaceutical analysis?
Sample answer:
Can you discuss your experience with developing and stability-indicating assays for pharmaceutical analysis?
My extensive experience in analytical chemistry, particularly in developing and stability-indicating assays for pharmaceutical analysis, has equipped me with a comprehensive understanding of the principles and techniques involved in this field. I have successfully developed and validated numerous stability-indicating assays for various pharmaceutical products, meeting the rigorous regulatory requirements.
Development of Stability-Indicating Assays:
- Conducted comprehensive stress studies to identify potential degradation pathways of the active pharmaceutical ingredient (API).
- Utilized advanced analytical techniques such as HPLC, LC-MS, and GC-MS to characterize and identify degradation products.
- Developed analytical methods that selectively detect and accurately measure the API and its degradation products, ensuring stability analysis accuracy.
Validation of Stability-Indicating Assays:
- Performed comprehensive validation studies to ensure the methods meet regulatory guidelines (e.g., ICH Q2A/Q2B).
- Evaluated method specificity, linearity, accuracy, precision, limit of detection, and limit of assay acceptance.
- Implemented quality control procedures to ensure the consistency and reliability of th… Read full answer