Extractables Leachables studies

At QACS Lab, we specialize in conducting comprehensive Extractables and Leachables studies for pharmaceuticals. Containers and closures utilized in pharmaceutical packaging may contain various additives, but it’s crucial to ensure that these materials do not release substances that could compromise the efficacy, stability, or safety of the product. To select the most suitable container, a thorough understanding of the complete manufacturing formula, including all materials used in its formation, is essential for assessing potential hazards.

Our Extractables and Leachables testing services are vital for achieving compliance with regulatory bodies such as the FDA and EMA (European Medicines Agency). These studies involve meticulous analysis to identify and quantify any traces originating from pharmaceutical containers, medical device packages, and manufacturing equipment. Our testing procedures cover a wide range of organic and inorganic components, including volatile and nonvolatile residues, alongside Elemental Impurities analysis. Extractables and leachables studies could be performed in final container closure systems (CCS), process equipment (single use systems, SUS) or medical device packaging.