Understanding the Behaviour of Pharmaceutical Polymers
This article discusses GPC and gives examples of the use of the technique in excipient analysis.
New philosophies in pharmaceutical industry such as Quality by Design (QbD) require a detailed understanding of the properties and behaviour of drug components, including polymeric excipients such as binders and disintegrants. Gel permeation chromatography (GPC, also known as size exclusion chromatography) is a vital tool for investigating the behaviour of polymers, and is increasingly employed in pharmaceutical laboratories to investigate macromolecules. This article discusses GPC and gives examples of the use of the technique in excipient analysis.
Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter <228>.
AOAC International Awarded NIST Grant for Developing Drug Testing Standards
October 31st 2024The grant will be part of a new collaborative scientific initiative to address the need for standards that define the desired performance of lateral flow immunoassay test strips to detect illicit drugs in tablets and powders.
