Definitions for Extractables and Leachables
| Source | Definitions | |
|---|---|---|
| Extractable | Leachable | |
| FDA Container/Closure Guidance1 | These terms are not defined in this text, although reference is made to extractables as coming from “extraction studies.” | |
| FDA Metered Dose Inhaler (MDI) and Drug Powder Inhaler (DPI) Drug Products Guidance2 | Compounds that can be extracted from elastomeric, plastic components or coatings of the container and closure system when in the presence of an appropriate solvent(s) | Compounds that can leach from elastomeric, plastic components or coatings of the container and closure system as a result of direct contact with the formulation of the MDI |
| FDA Nasal Spray, Inhalation Suspension and Spray Drug Products Guidance3 | Compounds that can be extracted from elastomeric or plastic components of the container closure system when in the presence of a solvent | Compounds that leach into the formulation from elastomeric or plastic components of the drug product container closure system |
| EMEA Guideline On Plastic Immediate Packaging4 | These terms are not defined in this text although both are used in the text. The word extractables is linked to the concept of an extraction study while the word leachable is linked to the concept of a migration study. | |
| PQRI OINDP Recommendations5 | Compounds that can be extracted from OINDP device components or surfaces of the OINDP in the presence of an appropriate solvent(s) and/or conditions(s) | Compounds which are present in the drug product due to leaching from the container/closure system components |
| ISO 10093-186 | Soluble substances removed from a material when treated with a solvent | Chemical removed from a medical device by the action of water or other liquids related to the use of the device |