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Software tools that enable confident GC-MS analysis of extractables in pharmaceutical products

Posted: 30 August 2018 | | No comments yet

Pharmaceutical products come into contact with a wide range of polymeric materials on their journey from the production line to patients. Plastic and rubber contact surfaces are present at almost every stage of a product’s lifecycle: they’re present in single-use systems, such as filters and tubing employed in manufacturing processes; the packaging components that protect medicines during transport; and the delivery devices, such as syringes, pens and inhalers used to administer treatments to patients.

WHILE these materials are essential to ensure the sterility and quality of medicines during their manufacture and storage, they can also pose a serious risk to human health. Certain pharmaceutical products and packaging materials are incompatible and, if paired, can result in the leaching of potentially dangerous substances into products, possibly compromising the stability or, even worse, the pharmacological activity. These components, known as extractables and leachables, are the focus of rigorous testing workflows to ensure therapeutics are safe for use and meet regulatory requirements.

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