Extractables and Leachables
Extractable and leachable testing and analysis is critical in maintaining the quality of your drug product or combination drug delivery device. Let our expert analysis help you maximise the chance of a positive drug registration.
As part of your drug’s development and route to market, it is vital to identify both the substance and source of any leachables as they may significantly alter the identity, strength or quality of the drug, risking patient safety.
There are a number of analyses which must be performed in order to comply with regulatory guidelines, and we can assist throughout with extractable and leachable testing. First, you need an extractables profile to be determined for all materials that will come into contact with your drug product. Once it has been determined whether any extractables in this profile are present as leachables within the product, you also need support in quantifying amounts and establishing the biological risk based on exposure.
We can provide analytical support during all stages of this process. We have performed controlled extractable and leachable testing and studies on a wide variety of containers, closures and medical combination drug delivery devices using state-of-the-art equipment, and our specialists’ expertise and experience means you can rely on us to successfully set up and manage your project.
Extractables and Leachables - Video
Find out how extractables and leachables studies are critical in maintaining the quality of a drug product and ensure that you meet all regulatory requirements.
- Liquid Chromatography-Mass Spectrometry (LC-MS)
- Gas Chromatography-Mass Spectrometry (GC-MS)
- Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)
- Nuclear Magnetic Resonance (NMR)
- Dionex (Ion Chromatography-Conductivity detection)
- Helps you gain regulatory approval for devices as part of FDA/MHRA submission
- Enables launch of new or generic drug product
- Delivery in a timely manner