Extractables Studies

Extractables Studies…

Extractables studies are an assessment performed on a material. Extractables studies are performed to identify substances that a patient may be exposed to through many different routes of administration, such as Orally Inhaled Nasal Drug Products, Parenteral, Production equipment - Single Use Systems, and Medical Devices.

Materials extraction studies are performed; generally using aggressive solvent conditions including acidic, basic, organic and aqueous solvents and sohxlet or accelerated solvent extraction. It is important that the extraction process does not deform the material of interest. Compounds present in the resulting extracts are called "extractables". Extractables studies are typically performed to create a "worst case scenario" and assist in materials selection and early risk assessment.