Akademik Veri Yönetim Sistemi
11. Uluslararası İlaç Kimyası Kongresi, Antalya, Türkiye, 9 - 12 Mart 2023
Extractables are compounds or elemental impurities that can be extracted
from the container and/or closure system of the drug under certain extraction
conditions. Although not all extractables leach into the drug formulation, extractables
are considered potential leachables.
Leachables are compounds or elemental impurities that migrate from the
container and/or closure system into the drug formulation under normal storage
conditions. Extractables and leachables (E&L) studies are required to
identify and any impurities that migrate from the packaging material to the
drug formulation and to assess their toxicological risk.
The profile of extractables and leachables are based on the material
used for container and closure. Plastic materials widely used in pharmaceutical
and medical fields are made of polymers such as polypropylene (PP),
polyethylene (PE), polyvinyl chloride (PVC), polyamide (PA), and polyethylene
terephthalate (PET). Plastics used for container and closure contain some
additives and their degradation products that are source of extractables and
leachables. The most common additives are plasticizers, UV absorbers,
antioxidants, and lubricants.1,2 These plastic additives,
potentially risk for human health, can migrate from the container and/or closure
to the drug formulation.
In this presentation, we will
discuss analytic methods for the identification extractables and
leachables in drug products.