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Cleaning Validation Glossary

Impurities

Unwanted substances in a product

Impurities are unwanted substances in a product and provide no therapeutic benefit. Examples include elemental and genotoxic impurities as well as nitrosamines. According ICH Q3A impurities arise from excipients present in the drug product. Some impurities are also referred to as degradation products. It is critical to processes that impurity safety data is understood as many are toxic to patients at higher concentrations.

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