Abstract
Background: Metallic impurities are the traces of metals that can be found in finished drug products.
Description: These metallic impurities in pharmaceutical preparations can enter from formulation ingredients, catalysts, and process equipment, containers and closures. They are not completely removed from the product by practical manufacturing techniques and should be evaluated relative to safetybased limits. They can affect drug efficacy or produce direct toxic effect on the patient.
Methods: In this paper, an attempt has been made to review these metallic impurities including potential sources and analytical procedures to quantify these impurities. ICH guideline on these impurities and measures to control impurities has also been discussed in the paper.
Results: The implementation of ICH Q3D guideline with the quality risk assessment approach is an important milestone to harmonize control of elements worldwide.
Conclusion: This approach allows manufacturers to provide vital information about the contribution of impurities in the drug product.
Keywords: Metallic impurities, heavy metals, pharmaceuticals, sources of impurities, ICH guidelines, elemental impurities.
Graphical Abstract
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