DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/25jkl3/leachables_and_ext) has announced the addition of John Wiley and Sons ...

Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study. Drug manufacturers invest a tremendous amount of ...

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies. Leachables from plastics in ...

The article provides a detailed overview of the process used to determine leachables and extractables from plastics. This process is mostly preferred for plastics employed in food contact applications ...

Dr Bettine Boltres, Product Manager, Pharmaceutical Tubing, SCHOTT, Germany in this white paper, touches on a risk-based approach of the evaluation and describes important facts to consider when ...

Not long ago, the assessment of extractables and leachables in drug products was performed mainly during late-phase research. Recently, regulators have been increasingly asking for additional E&L ...

Diane Paskiet, Director, Scientific Affairs, West Pharmaceutical Services, elaborates on the key quality considerations when designing drug product compatibility studies There are multiple types of ...

Drug manufacturers spend significant amount of time and money in characterizing, identifying, minimizing the impurities in a drug product so that regulatory bodies make accurate decisions with respect ...

In this interview, AZoM talks to Dr Mark Jordi, President of Jordi Labs, about extractables and leachables, and how they relate to the pharmaceutical industry. What are Extractable and Leachables?

Each supplier of single-use technology products has an implicit obligation to characterize the materials of construction used in the manufacture of its products and to share that information with its ...