Extractables and leachables testing
Abstract: Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) headquartered in Stockholm, Sweden. We operate development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK, and the US and are continuing to grow and expand for our customers. We are focused on supporting pharmaceutical companies with our full service offering, taking products from early development through to commercial production. Our development & technology division operate from seven facilities and work in close collaboration with the expertise of dedicated development scientists. We offer clients a comprehensive range of services from pre-clinical medicinal chemistry, API process development, formulation development to production of clinical trial material of drug products.
Description: Recipharm work with highly qualified analytical chemists and state-of-the-art technology to offer extractable and leachable (E&L) testing in accordance with the recommendations of a number of global organisations, including the FDA, EMEA, USP, PQRI, BPSA and BPOG.
Our E&L testing capabilities include a wide range of analytical techniques designed to identify and test all possible additives and impurities, which could migrate from packaging to the drug product, potentially affecting drug efficacy and patient safety.
We offer fully compliant E&L testing during new product development and following changes to packaging materials and manufacturing equipment, custom testing strategies, a range of analytical testing techniques such as HS-SPME-GC-MS, GC-MS, UPLC-UV-HRMS/MS and ICP-MS.
We also offer E&L testing of all possible additives including plasticisers, lubricants, pigments, stabilisers, antioxidants, UV-filters, monomers and slip agents. E&L testing of all types of leachable substances including volatile, semi-volatile, non-volatile and elemental. Testing and analysis beyond the regulatory requirements to offer a deeper understanding of the risks associated with any identified leachable substances.
Category: Drug Product
Type: Small Molecules
Contact: Mikael Bisrat ([email protected])