Answer Posted / Nitin Kumar Malviya
The limits of impurities, also known as impurity specifications, are set based on various factors such as safety, efficacy, and regulatory requirements. The International Council for Harmonisation (ICH) provides guidelines for establishing acceptable limits of impurities in pharmaceuticals. Factors affecting the limit setting include the nature and amount of impurities, their potential toxicity, and the intended use of the drug substance.
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