There are two main threats posed by extractables and leachables (E&L), contamination from unwanted impurities such as nitrosamine or chromium causing toxicity issues and diminution of drug efficacy or ...

Standardized risk assessment and analysis protocols facilitate the comparison of processing equipment components. The National Institute for Bioprocessing Research and Training (NIBRT) assessed the ...

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "Designing Effective and Efficient Extractables or Leachables Studies" training has been added to ResearchAndMarkets.com's offering. Learn the key phases ...

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?

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 ...

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

The regulatory requirements concerning the control of Extractables and Leachables (E&L) in pharmaceutical products are becoming more and more stringent. The European Pharmacopoeia has recently ...

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 ...

To help pharmaceutical and consumer healthcare companies bring their products to market safely and efficiently, scientific consultancy and contract research organization (CRO) Broughton has launched a ...

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 ...