Elemental Impurities: A Review

Abstract

The ICH Q3D is an important guideline to harmonize control of elemental impurities. The guideline sets strict limits for final drug products, limits for excipients, active pharmaceutical ingredients and other pharmaceutical drug products. The analysis of elemental impurities in the pharmaceutical products is most important in pharmaceutical industries. In the last decade noteworthy progress has been made in the analysis of elemental impurities. The changes from using special reagents which form precipitate with the metallic impurities and are detected by colorimetric methods to using highly sophisticated instruments for analysis. This review article will cover in brief about the classes of elemental impurities, their permitted daily exposures, concentrations, risk assessment, control strategies and instruments used for analytical testing. With the risk assessment approach, the contribution of elemental impurities of each component is assessed. The option 1 limit (based on 10 g daily dose) may be used as default concentration limit. This approach allows manufacturers to provide crucial information about the contribution of impurities in final drug products from excipients or active pharmaceutical ingredients.

Keywords:

Analytical, control limits, elemental impurities, ICH, risk assessment, strategy

Cite this Article

Vaibhav S. Adhao, Raju R. Thenge. Elemental Impurities: A Review. Research and Reviews: A Journal of Pharmaceutical Science. 2020; 11(1): 17–21p.