Assessment of Genotoxic Impurities

A potential genotoxic impurity (PGI) has been defined as an “Impurity that shows a structural alert for genotoxicity but that has not been tested in an experimental test model. Here potentially relates to genotoxicity, not to the presence or absence of this impurity”. Genotoxic impurities impact the genetic material using mutations through chromosomal breaks, rearrangements, covalent binding, or insertion into the DNA during replication which may result in carcinogenesis.

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Difference between ICP-OES and ICP-MS

Elemental impurities affect drug effectiveness, it doesn’t have any therapeutic benefit but has a toxic effect on the patients. Elemental impurities may be present in drug products due to different sources such as catalysts, raw materials, excipients, equipment, or packing materials. As per recent necessities, elemental impurities guidance of ICH Q3D, USP Chapters <232>, made effective shifting the old requirements for heavy metals. The limits are much lower for most toxic metals. The earlier heavy metal method was not specific and accurate for each one hence new testing procedure applied by using sophisticated, costly, and sensitive technology such as inductively coupled plasma optical emission spectroscopy (ICP-OES) or inductively coupled plasma mass spectrometry (ICP-MS). 

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