CPG performs extractables and leachable studies for product development, quality control, and regulatory approval for pharmaceuticals, medical devices, food products, cosmetics, and packaging.
What are leachables and extractables?
Extractables are compounds that can be removed from a product or material when subjected to exaggerated conditions (e.g., strong solvent or high temperature). Extractable studies are often used to replicate the worst-case scenario of how many compounds in a device or product could become leachables, i.e., compounds that can migrate from the device or product under realistic conditions. These studies can be used to evaluate what additives are in materials and at what concentrations. These studies are often required by the FDA and other regulatory bodies.
Leachables are compounds that migrate from a product into surrounding media or a contacting material under intended use conditions. Leachable compounds may include:
- Plastic additives, such as stabilizers and processing aids
- Monomers or low molecular weight species
- Manufacturing residues
- Inks and adhesives from primary packaging
Often, the material in contact with the product is plastic packaging, particularly in the pharmaceutical area. Leachable compounds from packaging can affect the drug product, modifying its behavior or introducing potentially harmful products to the patient along with the drug. Similarly, materials leaching from implants can potentially affect the patient.
Leaching studies are carried out under simulated conditions that mimic normal usage at multiple time points.
Extraction Conditions for Extractables and Leachables
For extractables studies, the relevant solvent for extraction is selected based on regulatory guidance. For leachables studies, scientists at CPG design simulated conditions to mimic the relevant environment for the product in question.
These conditions may be based on:
- Shelf-storage conditions for packaging studies
- In vivo environment for medical device behavior
- Animal studies
Leachables/Extractables Analysis
The analytical techniques to identify and quantify the extractables or leachables is selected based on the compounds of interest, but usually includes one or more of the following:
- LC-UV-MS
- GC-MS
- HS-GC-MS
- FTIR
- TOC
Analysis of leachables is often conducted as a function of time to determine the elution rate.
Relevant Standards
- ASTM D1045 Standard Test Methods for Sampling and Testing Plasticizers Used in Plastics
- ASTM D7823 Test Method for Determination of Low Level, Regulated Phthalates in Poly (Vinyl Chloride) Plastics by Thermal Desorption — Gas Chromatography/Mass Chromatography
- USP <661.1> Plastic Materials of Construction
- USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
- USP <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products
- USP <1661> Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction
- USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
- USP <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems
- USP <1665> Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products
- ISO 10993-12 Sample Preparation and Reference Materials
- ISO 10993-18:20 Chemical Characterization of Medical Device Materials Within a Risk Management Process
Contact us to have a discussion with one of our scientists about your project or to request a quote.