Multiple materials are involved in the packaging of drug products in prefillable syringes. Multiple materials are involved in the packaging of drug products in prefillable syringes. With regards to ...

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 ...

Extractables and leachables assessment is a critical facet of biopharmaceutical development and quality control, ensuring that medicines remain safe, effective and uncontaminated by substances ...

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 ...

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 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 ...

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?

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 ...

The regulatory requirements concerning the control of Extractables and Leachables (E&L) have become much more onerous in recent years. This course sets out the regulatory and scientific considerations ...

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 ...