A general guideline has been provided by FDA about extractables and leachables, however what should be measured has not been clarified. Guidance is also lacking on how to measure extractable and ...

Learn the key phases of an extractables and leachables (E/L) study, including literature gap analysis and efficient study design as mandated by FDA guidelines for drug and biologics packaging.

The FDA has released a revised draft guidance discussing quality considerations ... evaluation for extractables and leachables and identification of test methods and criteria for impurities ...

The Product Quality Research Institute (PQRI) - an independent consortium from industry, the FDA, and academia have issued a guidance document for leachables and extractables for nasal and orally ...

While the FDA already has biocompatibility guidance and recognized consensus standards, none of the existing documents provide a detailed methodology on how to run extractables studies and ...

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 ...

Fundamental to precise chemical analysis and risk assessment processes where Extractables and Leachables (E&L) are concerned is being able to determine and quantify relevant species in relevant ...

Learn the key phases of an extractables and leachables (E/L) study, including literature gap analysis and efficient study design as mandated by FDA guidelines for drug and biologics packaging. Given ...