It’s important for pharmaceutical manufacturers to be aware of extractables and leachables, which are chemical species that can migrate into their products during use or storage. Leachables are a subset of extractables and can be caused by various materials, while extractables represent the worst-case scenario. Laboratories can be used to assess whether these chemicals are transferring into drugs from packaging or production, and toxicological assessments can be made to gauge the level of risk posed by these materials.
Please find below our supporting resources:
- Mass Spectral Accuracy Applied to the Quantitative Analysis of Deamination Impurities in Oligonucleotide TherapeuticsISIS PharmaceuticalsS.Kan,H.Xu,Y.Wang,C.Rentel ASMS2011
- CernoM.Gu Appnote105
- CernoM.Gu,Y.Wang Asimolar2004