Sample interview questions: Have you ever participated in the development of stability-indicating methods for the analysis of pharmaceutical products? How did you validate them?
Sample answer:
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Participation in Stability-Indicating Methods Development:
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Formulation Development: Collaborated with formulation scientists to design and develop pharmaceutical formulations with desired stability characteristics.
- Chromatographic Method Design: Expertise in method development using various chromatographic techniques (HPLC, GC, and LC-MS) to separate and quantify pharmaceutical components and degradation products.
- Degradation Studies: Conducted accelerated and long-term stability studies under various environmental conditions (temperature, humidity, and light) to assess the stability of pharmaceutical products.
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Method Validation: Performed validation studies to demonstrate the accuracy, precision, linearity, specificity, robustness, and sensitivity of the developed stability-indicating methods, ensuring they meet regulatory requirements.
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Validation of Stability-Indicating Methods:
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Accuracy: Evaluated the accuracy of the method by spiking known amounts of the drug substance and degradation products into placebo samples and analyzing them. The percentage recovery and % RSD values were calculated to assess the accuracy of the method.
- Preci… Read full answer
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