The Product Quality Research Institute Leachables and Extractables Working Group includes
pharmaceutical development scientists representing industry, government, and academia. …

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

A simulating leaching (migration) study was performed on a model container-closure
system relevant to parenteral and ophthalmic drug products. This container-closure system …

A detection Interface has been designed to alow for the addition of post column reagents to
evaluate chemiluminescence as a method of detection for capllary electrophoresis. The …

Leachables and Extractables (L&E) issues represent some of the most significant 132
challenges facing a pharmaceutical development team responsible for the registration and 133 …

An acridinium ester has been used to tag mixtures of peptides followed by separation by
capillary electrophoresis with chemiluminescence detection. The labelling of the peptides was …

The materials used to fabricate single-use processing equipment for biopharmaceutical
manufacturing are usually polymers, such as plastic or elastomers (rubber), rather than the …

Leachables from drug product container closure system from primary and secondary packaging
components that migrate into the drug product can have a potentially negative impact on …

… Michael Ruberto … Michael Ruberto is the president of Material Needs Consulting LLC,
which provides consulting services to manage the development and commercialization of …

This article presents the winner of the New York Society of General Semantics Michael
Ruberto Award for Distinguished Service. The award was presented at the symposium" The …