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 ...

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?

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 ...

Let us help you with your inquiries, brochures and pricing requirements Request A Quote Download PDF Copy Request A Quote Download PDF Copy Request A Quote Download ...

The MarketWatch News Department was not involved in the creation of this content. In this free webinar, best practices for conducting extractables and leachables testing specific to drug-device ...

For most researchers, it’s hard to believe that the tubes and tips they use every day could impact and even skew their experimental results. But recent reports show that chemicals used to formulate ...

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 ...

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 ...

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 ...

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) in pharmaceutical products are becoming more and more stringent. The European Pharmacopoeia has recently ...