Finding what can move from packaging, closures and process equipment into drugs, peptides, supplements and cosmetics
Plastics, rubber stoppers, liners, inks and adhesives all contain additives, monomers and breakdown products that can move into whatever they touch. Extractables testing finds what can come out of a material under harsh conditions. Leachables testing finds what actually does come out into your product during storage. We use high-resolution LC-MS, GC-MS and ICP-MS together, so organic, volatile and elemental compounds are covered in one study.
Studies are quoted to your material and product.
Packaging or component material is extracted with solvents of different strengths, with heat and time, to find everything that could come out of it.
Your product is tested over its shelf life for the compounds that matter from the extractables profile, often at the same pulls as a stability study.
Unknown compounds are identified by accurate mass, isotope pattern and fragmentation, compared against spectral libraries, and confirmed with reference standards where needed.
Metals and other elements from glass, rubber and pigments measured by ICP-MS.
An extractables study starts with the material and how it is used: what touches the product, at what temperature, for how long. We pick extraction solvents that cover the range from water to strong organic solvent, and conditions harsh enough to bring out more than normal use would. Each extract is analyzed for volatile compounds by headspace GC-MS, semi-volatile compounds by GC-MS, non-volatile compounds by high-resolution LC-MS, and elements by ICP-MS.
Leachables testing then looks for the compounds that matter in the product itself, with targeted methods sensitive enough to find them at the levels a safety assessment needs. Study design follows the general approach in USP 1663 for extractables and USP 1664 for leachables.
You get a list of every compound found, with its identity, how confident the identification is, and how much was found. Results are compared against the analytical evaluation threshold for your product. A toxicological risk assessment of the results is done by a toxicologist, and we can work with yours.
Tell us about the material, the product and how they meet.
Solvents, conditions, thresholds and the tests for each extract.
Every compound found, identified and measured.
Targeted testing in your product, often alongside a stability study.
Extractables are what can come out of a material under harsh conditions. Leachables are what actually comes out into your product under normal storage. Leachables are usually a subset of extractables.
Often an extractables study is enough to choose a package or show a material is low risk. Products that are injected, inhaled or used on the eye usually need leachables data as well.
Often, yes. Accurate mass, isotope pattern and fragmentation narrow down the structure, and a reference standard confirms it when one is available. Some compounds can only be reported as tentative identifications, and the report says which ones.
It depends on the number of solvents and conditions. We give you a timeline with the quote.
No. We report what was found and how much. A toxicologist uses that data for the risk assessment, and we can work with yours.
Tell us about your material and product and we’ll send back a quote. You can also email [email protected].
