Extractables and Leachables
Regulatory authorities are increasingly concerned with the potential exposure of harmful substances to patients either from packaging materials (or other materials in contact with drug product) or medical devices. Extractables and Leachables (E&L) testing is used to identify such compounds and elements by following USP<1663> and <1664> for drug products and ISO 10993 for medical devices and by employing a range of analytical techniques. Our expert analysts here at Lucideon can work with you to perform E&L testing and subsequently help to minimize associated risks with your products.
Extractables analysis identifies substances which could potentially migrate from polymeric, metallic or glass material into the patient or consumer, examples include dyes, catalysts and plasticizers. The extractions follow ISO 10993 or USP<1663> and typically cover a range of solvent polarities or similar extraction media to the drug product formulation. LC-MS, GC-MS and ICP-MS analysis are the most widely used techniques but other techniques may be employed as required.
Leachables analysis identifies substances which do migrate from polymeric, metallic or glass material into the patient and are typically a subset of those identified in the extractables analysis. This type of analysis is particularly required when a liquid product is to be consumed by a patient and there is a risk that harmful substances may have leached into that solvent from its container or packaging e.g. eye drops.
Our extractables and leachables testing also covers analysis of e-cigarettes and drug delivery systems such as syringes.
Any changes to a product’s immediate packaging materials require regulatory analysis to assess the impact of the changes.