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LO-1
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Define the concept of impurities and explain their significance in pharmaceuticals. |
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LO-2
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Classify different types of impurities in drug products and describe their sources (e.g., process-related, degradation-related). |
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LO-3
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Interpret ICH guidelines (e.g., ICH Q3A-Q3D) and pharmacopeial standards (e.g., USP, EP) for impurity control. |
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LO-4
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Evaluate impurity limit thresholds and regulatory requirements (e.g., EMA, FDA). |
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LO-5
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Explain chromatographic (e.g., HPLC, GC) and spectroscopic (e.g., UV, IR) methods used in impurity analysis. |
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LO-6
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Describe analytical method validation processes. |
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LO-7
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Discuss degradation products and forced degradation/stability studies. |
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LO-8
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Outline computer-assisted impurity analysis techniques. |