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 ...

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 ...

Extractables and leachables (E&L) have become a focal point in pharmaceutical quality assurance due to their potential impact on drug safety and efficacy. Extractables are chemical entities that can ...

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

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 ...

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 ...

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 ...

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 ...

What are extractables and leachables? Why do we need to detect extractables and leachables? How could it help solve problems and what answers could it give? When do we use extractables and leachables ...