An impurity is any component present in a drug or cosmetic product that is neither the active ingredient nor an intended excipient. Impurity qualification is the scientific evaluation of the safety of impurities—such as process residues, degradation products, or contaminants—at the levels they are present, ensuring they pose no risk to patients or consumers.

Unqualified impurities may exhibit potentially toxic effects and compromise the safety and efficacy of the product. Qualification studies demonstrate the biological safety of impurities, satisfy ICH Q3A/Q3B and ICH M7 requirements, and help to protect consumer health.

Impurities often requiring qualification include, but not limited to:

• Process-related residues (solvents, reagents, catalysts)

• Degradation products formed during storage

• Extractables and leachables from packaging and delivery systems

• Genotoxic impurities requiring assessment according to ICH M7

• Elemental impurities in line with ICH Q3D requirements

• Microbial impurities – particularly relevant for biologicas and cosmetics

SciQra aligns impurity assessments with ICH, FDA, EMA, and other applicable regulatory standards. We provide impurity profiling, toxicological risk assessment, and human health risk assessments using Threshold Of Toxicological Concern (TTC) approach and help to streamline global compliance. 

If impurities surpass allowable limits and cannot be justified toxicologically, corrective actions may include manufacturing process changes, reformulation, or tighter specifications. Early toxicological input helps anticipate risks, avoid late-stage regulatory setbacks, and keep development timelines on track.