Question

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Answer 1

Answer:

1. ICH further classifies organic impurities as starting materials, by-products, intermediates, degradation products, reagents, ligands and catalysts.
2. Impurities in organic drug molecules can be developed during organic synthesis, formulation or upon aging of active pharmaceutical ingredients, which may affect the quality, safety, and efficacy of drugs. ... The term 'impurity' can be defined as something that is impure or makes something else impure.

Answer 2

Answer:

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