Extractables and Leachables
At Netpharmalab we develop a comprehensive approach in the studies of Extractables and Leachables, essential to evaluate the release of potentially toxic components from the materials used in the packaging and processing of pharmaceutical products, cosmetics and foods to the final product. These studies are vital to ensure the safety of patients and consumers.
Common materials such as plastics, aluminum, resins and other polymers can release metals, as well as volatile and non-volatile components that could be toxic or harmful to health. Therefore, it is crucial to evaluate and control its presence in the finished product. We use advanced analysis techniques, including equipment such as LC/MS, GC/MS and ICP/MS, to provide accurate and complete evaluations.
Pharmaceutical and biopharmaceutical containers and delivery systems, as well as materials used in manufacturing processes, can be potential sources of contamination. Our controlled extraction studies identify and quantify extractable impurities that could migrate under severe use conditions.
Toxicological risk testing
Our approach to E&L (Extractables & Leachables) studies is based on Quality Risk Management (QBD) principles and a deep knowledge of the manufacturing process. We perform a toxicological risk analysis to define the actual presence of each extractable in the maximum dose of the product. Subsequently, leachable studies allow us to evaluate the presence of leachable impurities in the finished product, thus ensuring its quality and safety.
At Netpharmalab we are committed to meeting regulatory expectations and continuing to evolve our practices to ensure the highest quality and safety. Our team of experts, with extensive experience in specialized analysis and toxicological evaluation, works to identify and characterize both organic and inorganic contaminants through advanced analytical instrumentation.
Feel free to contact our team of experts in toxicological testing and analysis of the release of potentially toxic elements and guarantee the safety of your products.
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