A review is provided on the general topic of the compatibility of plastic materials with
pharmaceutical products, with specific emphasis on the safety aspects associated with extractables …

Validation of analytical methodologies is an important aspect of their development/utilization
and is widely required in support of product registration applications. In this manuscript, …

Polymeric and elastomeric materials are commonly encountered in medical devices and
packaging systems used to manufacture, store, deliver, and/or administer drug products. …

Validation of analytical methodologies is widely recognized as an important aspect of the
development/utilization of analytical procedures and is widely required in support of product …

Pharmaceutical drug products (DP) can contain foreign impurities due to contact with
manufacturing, storage, distribution and administration systems. These foreign impurities (…

The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations
working together to generate and share timely, relevant, and impactful information that …

Organic extractables (substances extracted from materials used in pharmaceutical packaging)
are discovered, identified, and quantified via screening of extracts with analytical methods …

The interaction between a medical device and a pharmaceutical solution it contacts may
dictate solution safety and/or efficacy. Of specific concern is the ability of device components to …

A review is provided related to the accumulation of organic and inorganic leachable substances
from DEHPplasticized PVC, polyolefin and various other related pharmaceutical plastic …

I think it was at the 2005 Extractables and Leachables Forum, sponsored by the PDA, where
someone said those fateful words,“Someone ought to write a book about this stuff”. Having …