Abstract Structure elucidation and quantitation of leachable impurities in pharmaceutical and
medical products are crucial because unidentified and potentially toxic leachable impurities …

Migration studies are one of the few domains of pharmaceutical analysis employing wide-
scope screening methodologies. The studies involve the detection of contaminants within …

The analytical evaluation threshold (AET) establishes which chromatographic peaks,
produced during organic extractables/leachables (E&L) screening, require toxicological …

Single-use (SU) devices and assemblies used as manufacturing equipment in the
biopharmaceutical industry require comprehensive qualifications. These qualifications …

Sample introduction in the GC-MS analysis is a relatively complex, multistep process, where
usually a liquid sample is introduced to an injector, evaporated, and transferred to the GC …

Leachable testing for finished pharmaceutical products is an important part of the regulatory
filing and is under more regulatory scrutiny than ever before. Leachable testing for multiple …

Leaching is a physical process occurring between clinically relevant solutions and materials,
where chemical material constituents (leachables) migrate towards the solution 1. Polymers …

The assessment of substances that can be extracted (extractables) or leached (leachables)
from the materials that come in contact with pharmaceutical products often starts with a …

Analytical data packages are an essential part of the CMC (Chemistry and Manufacturing
Control) section of US FDA (United States Food and Drug Administration) NDA (new drug …