Pharmaceutical extractables and leachables testing is a crucial aspect of ensuring drug safety and quality. The process involves assessing potential interactions between primary container-closure systems, packaging components, and the drug dosage form. In this blog, we’ll discuss the importance of such testing and highlight the technical capabilities of Synergy Bioscience, a leader in the field.
Why Extractables and Leachables Testing Matters:
Extractable are chemical species that can be released from container or closure materials, potentially contaminating the drug dosage form. Leachable, on the other hand, migrate from packaging components into the drug dosage form under normal use or during stability studies. These substances can interfere with drug assays, increase impurity levels, and even raise toxicity levels.
Considering factors like materials, surface treatments, processing aids, active ingredients, excipients, sterilization processes, and storage conditions is essential in this process. Testing is crucial even when the containers and closures meet compendial suitability tests to ensure the safety and quality of the drug product throughout its shelf life.
Synergy Bioscience has extensive experience and capabilities in conducting extractable and leachable tests. They use a range of analytical techniques, such as LC-MS, GC-MS, ICP, and IR, to identify leachables, ensuring container-closure components are safe, compatible, and provide adequate protection throughout the drug’s shelf life.
Our testing process includes extractable screening during safety studies, prescreening procedures, identification of extractable, methods development, and method validation. Synergy Bioscience works closely with clients to develop and validate testing methods according to industry practices and International Conference for Harmonization (ICH) Guidelines.
As the FDA’s 1999 Container Closure Guidance has heightened the requirements for extractable and leachable testing of container-closure packaging components, partnering with a trusted company like Synergy Bioscience is essential. Our expertise in extractables and leachables testing helps pharmaceutical manufacturers reduce risk, accelerate development timelines, and achieve successful product launches.
Don’t compromise on safety and quality. Trust Synergy Bioscience for your pharmaceutical extractable and leachable testing needs. Contact us today to learn more about our comprehensive testing and analysis services and safeguard the safety and efficacy of your pharmaceutical products.