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Welcome to our impurities hub, where you will find a wide range of tools and technical resources – all aimed at improving your impurities testing for pharmaceutical products.

From initial drug substance manufacturing to the packaging of a finished drug product, sources of impurities in pharmaceutical products are many and varied. Potential risk factors range from process related impurities that can occur during the active pharmaceutical ingredient (API) development process to extractable and leachable (E&L) impurities formed when finished drug products interact with a range of packaging, closure and delivery components.

In the worst cases, pharmaceutical impurities can compromise patient safety – reducing therapeutic efficacy, causing unpredictable side effects, and even increasing cancer risks. But impurities in pharmaceutical products can also have a devastating effect on manufacturers’ profitability and reputation – as evidenced by several high-profile drug recalls linked to nitrosamine contamination.