Extractables and Leachables Testing
Regulatory authorities are increasingly concerned with the potential exposure of harmful substances to patients either from packaging materials (or other materials in contact with the 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 and leachables studies are performed to detect the presence of harmful compounds that can contaminate pharmaceuticals, which could leach from container closure systems, packaging systems and processing equipment. In sufficient quantities these compounds could affect the functionality, appearance, and even toxicity levels of the drug product.
Our extractables and leachables testing can identify both organic and inorganic contaminants.
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.
Manufacturers are expected to perform E&L testing on materials used in production systems, delivery systems, and container closure systems. Failure to provide this information could lead to rejection of regulatory submissions. A profile is developed of all potential extractable compounds that could leach into your pharmaceutical product. This can be extremely complex due the different types of materials and environments involved. It is important therefore that your extractables and leachables studies are designed specifically for your product, processing facilities and storage units. This profile then makes it quicker and easier to identify leachables and the toxicological risk can be assessed.
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.