Impurities

Impurities pose risks to manufacturers, regulators and public health. USP can help.

When it comes to the manufacturing of medicines, impurities can pose very serious risks. Contaminants discovered in manufacturing can delay product approvals. Impurities discovered in products already on shelves can trigger drug recalls and prompt regulatory actions. Prioritizing quality earlier and throughout the process can help manufacturers maximize efficiency, manage costs and reduce risks.

Impurities in medicines can arise throughout the manufacturing process and even in transportation or storage. To minimize such risks, manufacturers must find ways to limit levels of impurities early and throughout the product lifecycle – from development to manufacturing and distribution.

USP is a strategic partner for industry and regulatory agencies in developing standards and associated analytical methods, insights and other solutions that help a manufacturer assess risk and detect impurity levels in a large range of therapeutic products approved in the US and globally. Regulators around the world rely on USP standards, including those for impurities, to assure quality in their products and manage risk in the drug approvals process and post-market surveillance.

USP is uniquely positioned, informed by experience working with manufacturers and regulators around the world, to offer insights about quality, facilitate knowledge-sharing among stakeholders and provide proven solutions. USP’s varied resources can help reduce the risk of unsafe impurity levels in the manufacturing process, ultimately ensuring patients have the medicine they need when they need it. 

analytical impurities
analytical impurities

Don’t ignore the small peaks. Tackle impurities now.

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Standards & solutions

hand sanitizer

Case study: USP responds to contaminants in hand sanitizers during COVID pandemic 

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nitrosamine impurities

USP standards and solutions are responding to drug recalls

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