| pharma. |
leachables (USP: Leachables are foreign organic and inorganic chemical entities that are present in a packaged drug product because they have leached into the packaged drug product from a packaging/delivery system, packaging component, or packaging material of construction under normal conditions of storage and use or during accelerated drug product stability studies. Because leachables are derived from the packaging or delivery system, they are not related to either the drug product itself or its vehicle and ingredients. Leachables are present in a packaged drug product because of the direct action of the drug product on the source of the leachable. Thus leachables are typically derived from primary and secondary packaging, as the primary and secondary packaging can serve as a barrier between the packaged drug product and other potential sources of foreign chemical entities (such as tertiary packaging and ancillary components). In certain circumstances, packaging may directly contact the patient under typical clinical conditions of use (for example, the mouthpiece of a metered dose inhaler). As a result of this contact, patients may be exposed to leachables from the packaging without the action of the drug product. Leachables are typically a subset of extractables or are derived from extractables. Wakeful dormouse) |
