what is classification of elemental impurities? what is risk assement in elemental impurities?
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Answer / Munindra Kumar Mishra
Classification of elemental impurities is based on their potential toxicity. They are classified into Category A, B, and C, with Category A containing elements that have known adverse health effects or are carcinogenic, Category B containing elements that have no known adverse health effects but may pose a risk if present at high levels, and Category C containing elements that do not pose a significant risk at low levels. Risk assessment in elemental impurities involves evaluating the potential impact of these impurities on the safety and efficacy of the drug product.
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