What Are Extractables and Leachables?

Extractables are chemical compounds that can be released from a material under aggressive conditions, such as exposure to solvents or high temperatures. Leachables, on the other hand, are substances that migrate from a product during normal use or storage. These compounds often come from polymer systems and include antioxidants, plasticizers, surfactants, and residual monomers, which can pose risks to patient safety if not properly evaluated.

E&L testing is critical for ensuring that the materials used in medical devices, pharmaceutical packaging, and food contact applications are safe, high-quality, and free of harmful chemicals.

Why E&L Testing is Crucial for Safety and Compliance

Patient and Consumer Safety

Detecting harmful extractables and leachables helps prevent potential toxicity or allergic reactions in users.

Regulatory Compliance

E&L testing is often mandated by regulatory bodies like the FDA, EMA, and ISO for medical devices, pharmaceuticals, and food packaging.

Quality Assurance

E&L testing helps maintain product integrity, ensuring consistent performance across production batches.

Jordi Labs' Comprehensive E&L Testing Process

Jordi Labs, an RQM+ company, utilizes a systematic approach to E&L testing, combining decades of experience with state-of-the-art analytical technologies. 

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We ensure samples are representative of the final product, preparing them in the format they will be used or marketed. This step is critical to ensure the validity and relevance of the E&L testing results.

Jordi Labs employs multiple solvent systems—polar, mid-polar, and non-polar—to extract a wide range of potential leachables. Depending on the product's application, we conduct exhaustive extraction, exaggerated conditions testing, or simulated-use extractions to mirror real-world exposure.

  • Gas Chromatography-Mass Spectrometry (GC-MS) for volatile and semi-volatile compounds.
  • Liquid Chromatography-Mass Spectrometry (LC-MS) for non-volatile compounds.
  • Nuclear Magnetic Resonance (NMR) for detailed molecular structure analysis.
  • Fourier Transform Infrared Spectroscopy (FT-IR) and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for identifying inorganic compounds.

Identifying unknown compounds is one of the most challenging aspects of E&L testing. Jordi Labs excels in this area, using extensive databases and expertise to accurately identify and quantify both extractables and leachables.

Quality Control and Method Validation

Quality is a top priority at Jordi Labs, an RQM+ company. We incorporate rigorous quality control measures into every step of the E&L testing process:

  • Use of analysis blanks, negative controls, and spiked positive controls to ensure the accuracy of our data.
  • Full validation of analytical methods to ensure reliability and reproducibility.

These quality control measures guarantee that the results of our E&L analysis are precise, reproducible, and suitable for regulatory submissions.

RQM+ Expertise in E&L Testing

Experience

Over 40 years of expertise in handling complex polymer systems and small-molecule identification.

Advanced Instrumentation

Our laboratory uses state-of-the-art analytical tools to deliver highly accurate and sensitive results.

Comprehensive Services

From study design to reporting, we provide a complete E&L testing solution tailored to your specific product requirements.

Regulatory Knowledge

Our team is well-versed in the regulatory requirements across multiple industries, including medical devices (ISO 10993), pharmaceuticals, and food safety standards.

Why Choose RQM+ for Your E&L Testing Needs?

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At RQM+, we are committed to delivering the highest-quality extractables and leachables testing through Jordi Labs, an RQM+ company. Our extensive expertise in analytical chemistry, combined with advanced instrumentation and a deep understanding of regulatory requirements, ensures your products are safe, compliant, and ready for market. 

Partner with RQM+ to ensure the safety and compliance of your products. Talk to our E&L experts today.

We are passionate about your success. Tell us more about your needs so we can help.

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