Publisher Summary This chapter focuses on the structure, biological source, and properties
of glycosphingolipids. Several reasons can be cited for the explosive increase in the number …

Leachables from pharmaceutical container closure systems can present potential safety
risks to patients. Extractables studies may be performed as a risk mitigation activity to identify …

For particles to be useful medicinal aerosols, not only their aerodynamic diameter has to be
on the order of a few micrometers but also they have to be chemically and physically stable. …

Elemental impurities in drug products can arise from a number of different sources and via a
number of different means, including the active pharmaceutical ingredient, excipients, the …

A practical and science-based approach for addressing toxicological concerns related to
leachables and extractables associated with inhalation drug products Packaging and device …

Leachables from pharmaceutical container closure systems are a subset of impurities that
present in drug products and may pose a risk to patients or compromise product quality. …

The effective management of leachables in pharmaceutical products is a critical aspect of
their development. This can be facilitated if extractables information on the materials used in a …

Polymeric materials are often used in pharmaceutical packaging, delivery systems, and
manufacturing components. There is continued concern that chemical entities from polymeric …

A new method has been developed to monitor glycosyltransferase and glycosylhydrolase
activities. Reaction product identification and quantification are accomplished simultaneously …

In 2006, the Product Quality Research Institute's (PQRI) Leachables and Extractables
Working Group released a comprehensive and detailed recommendation document related to …