Sample interview questions: Have you ever faced challenges in developing stability-indicating methods for pharmaceutical analysis? How did you overcome them?
Sample answer:
Challenges and Solutions in Developing Stability-Indicating Methods for Pharmaceutical Analysis
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Interfering Excipients: Complex drug formulations may contain excipients that interfere with the detection or stability of the active pharmaceutical ingredient (API). To address this, comprehensive stress studies can identify potential degradation pathways and excipients that contribute to instability. Optimization of extraction and sample preparation techniques can minimize matrix effects and improve method accuracy.
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Degradation Product Quantification: Identifying and quantifying degradation products is crucial for stability assessment. However, co-elution of degradation products can hinder accurate quantification. Advanced chromatographic techniques, such as two-dimensional chromatography or mass spectrometry detectors, can provide enhanced separation and identification capabilities.
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Sample Matrices: Biological samples, such as plasma or urine, introduce additional challenges due to matrix complexity. Matrix effects can affect analyte stability and ionization efficiencies. Matrix elimination or extraction st… Read full answer
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