Extractables are organic and inorganic chemicals that are released into an extraction solvent from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions. The laboratory conditions typically intentionally accelerate or exaggerate the normal conditions of storage and use. Extractables, or chemicals derived from extractables, have the potential to leach into a drug product under normal conditions of storage and use and become leachables. Extractables testing is performed following relevant guidance documents: ISO 10993-12, ISO 10993-18, and USP <1663>, for example.
This type of testing is used to determine if there are any chemical compounds in a product that could potentially raise toxicity concerns. If you’re curious about which industries or products use this type of testing, just ask our Applied Chemistry & Spectroscopy lab manager, Alan Sentman! “Medical devices, pharmaceutical packaging, single-use bioprocess components, food contact materials, are just a few of the products that may undergo extractables and leachables testing,” he explained.
For patient safety and drug efficacy, it is important that extractables, leachables, impurities, and degradants are properly characterized and understood. Impurities in medical devices and pharmaceutical products can include residual solvents and process-related materials. Degradants occur as a result of a breakdown, or degradation, of the components in a product.
While we’ve blogged about extractables and leachables testing before, we think that it’s time extractables testing had the spot light!
Extractables Testing vs Leachables Testing
Let’s start by exploring the differences between extractables testing and leachables testing.
Extractables are chemical compounds that can be extracted from devices, production equipment, or packaging through aggressive methods to ensure all potential compounds are extracted in a reasonably short time period. Extractables tests, by design, use extreme conditions of heat, pressure, strong acids, powerful organic solvents, and other means designed to be reasonably quick and exhaustive.
Leachables, on the other hand, are the organic and inorganic substances that migrate from component materials into a product during normal product application or storage conditions. Leachables tests are performed using experimental conditions that more closely resemble product conditions during the average lifecycle.
So when is it appropriate to perform extractables testing and why is it important?
When there is a process change or a material change, it is important to perform extractables testing to determine the chemical compounds that are released. The chemicals and their concentrations are used to make a determination of risk with respect to biocompatibility and toxicity.
For example, an extractable analysis of a plastic material used to manufacture a medical diagnostic product indicated the presence of the following:
- t-butylphenol and an organophosphate secondary antioxidant using GC-MS
- A sterically hindered phenolic primary antioxidant and an organophosphate secondary antioxidant using HPLC
- A sorbitol-based nucleating agent using HPLC
- Aluminum, calcium, and phosphorus using ICP-OES
After reading this post, you may be wondering, “What about leachables?” Stay tuned for a blog post dedicated to leachables very soon!
Here at SGS PSI, we have over 30 years of independent testing experience. If you’re in need of independent testing from an industry-leading laboratory, contact us today!