Elemental Impurities: Risk Assessment and Significances | Veeprho
Elemental Impurities: Risk Assessment and Significances
The ICH Q3D Guideline for Elemental Impurities came into effect in January 2018 for all products for human use. It is supplementary safety-based guidance for toxic impurities that added the existing ICH Q3C and ICH M7 as well as the existing guidelines for non-toxic impurities ICH Q3A and non-toxic degradants ICH Q3B.
However, it does not specify limits for the major components of drug products. This brings excipients in particular under examination, being they, unlike APIs, lack established daily doses.
Due to the low limits of elemental impurities, there is a requirement for most advanced instruments ICP-MS. The new guidance address not only the most toxic metals but also the number of elements introduced intentionally, fetching the total number of elements that are 24. The requirements are shown below in Table.
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