What Are Chemical Characterization and Extractables/Leachables?

Chemical characterization and extractables/leachables (E&L) studies are critical physicochemical analyses conducted to identify chemical components that may originate from materials in contact with medical devices, pharmaceutical packaging systems, biotechnology products, and drug delivery systems, and to assess the associated risks.

These studies have become one of the fundamental requirements of international regulations for assessing product safety and determining patient exposure. In the medical device sector in particular, chemical characterization studies constitute a significant part of biocompatibility assessments.

At NanoTox, through our Physico-Chemical Test Unit, we offer Chemical Characterization and Extractables/Leachables analysis services in compliance with international standards, leveraging our advanced analytical instrumentation and team of experts.

What Are Extractables and Leachables?

Extractables

Extractables refer to potential chemical components that may migrate from a product or packaging material into the environment under aggressive extraction conditions.

These studies enable the comprehensive identification of all possible components that may be released from the material.

Leachables

Leachables, on the other hand, refer to chemical substances that migrate into the product under actual use or storage conditions.

Leachables studies play a crucial role in assessing the actual exposure of the patient or user.

By evaluating extractables and leachables studies together, a comprehensive chemical safety profile is established.

Why Are Chemical Characterization and E&L Studies Important?

Even low levels of chemical components released from materials can pose a risk to patient safety during long-term use.

These studies are widely applied, particularly in:

• Medical devices,
• Pharmaceutical packaging systems,
• Drug delivery systems,
• Implants,
• Single-use bioprocess equipment,
• Biotechnological products

Analytical Techniques Used

At NanoTox laboratories, Chemical Characterization and Extractables/Leachables analyses are performed using various advanced analytical techniques tailored to the properties of the target compounds.

Commonly used methods:

• Gas Chromatography–Mass Spectrometry (GC-MS)
• Liquid Chromatography–Mass Spectrometry (LC-MS/MS)
• ICP-MS analyses
• ICP-OES analyses
• FTIR analyses
• Headspace GC analyses
• TOC analyses
• UV-Vis Spectrophotometry

These methods enable the detection of chemical components at very low levels with high precision.

Studies Conducted in Compliance with International Standards and Guidelines

Studies conducted at NanoTox are carried out in accordance with international standards and regulatory guidelines.

Key reference documents:

• ISO 10993-18 – Medical Devices – Biological Evaluation – Chemical Characterization of Materials
• ISO 10993-17 – Establishment of Allowable Limits for Leachable Substances
• ISO 10993-12 – Sample Preparation and Reference Materials
• USP <1663> – Assessment of Extractables Associated with Pharmaceutical Packaging Systems
• USP <1664> – Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Systems

These standards ensure that the data obtained are evaluated in accordance with internationally accepted quality criteria.

Parameters Evaluated Within the Scope of Testing

Within the scope of Chemical Characterization and Extractables/Leachables studies:

• Volatile organic compounds (VOCs),
• Semi-volatile organic compounds (SVOCs),
• Non-volatile organic compounds (NVOCs),
• Elemental impurities,
• Process-derived residues,
• Monomers and additives,
• Decomposition products,
• Patient exposure assessments

are analyzed.

These data play a fundamental role in establishing the chemical safety profile of products.

Reliable Chemical Characterization and E&L Studies with NanoTox

NanoTox conducts Chemical Characterization and Extractables/Leachables studies in accordance with international standards, leveraging its expert analytical chemistry team, advanced laboratory infrastructure, and GLP-compliant operational system. We provide the reliable chemical safety data required by the medical device, pharmaceutical, and biotechnology sectors.

For detailed information on Chemical Characterization and Extractables/Leachables analyses, please contact NanoTox.