Extractables and Leachables Testing of Drug Products

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.<o:p></o:p>

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.<o:p></o:p>

In this presentation, we will

discuss analytic methods for the identification extractables and

leachables in drug products.<o:p></o:p>