Extractables & Leachables

Extractables & Leachables refer to chemicals released from a product or material that may enter or come into contact with the human body during the use of the product. Protheragen-ING Lab provides complete extractables and leachables testing for the pharmaceutical, biomedical, medical device and consumer goods industries to ensure that products do not produce substances that may pose a risk to human health during production, storage and use.

Our staff has extensive experience performing extractables and leachables studies that meet the expectations of regulatory agencies, including the FDA. Our processes comply with ISO 10993, USP <661.1>, <661.2>, <1663>, <1664>, <1664.1>, and industry best practices from the Product Quality Research Institute (PQRI) and BioPhorum Operations Group (BPOG).

Our Services

Protheragen-ING Lab provides technical support to ensure patient safety and timely product approval. Protheragen-ING Lab's team includes experts familiar with FDA review and approval who can determine whether any ingredient in contact with the product can negatively affect the product when exposed to stressful conditions (extractable) or when used regularly over a long period of time (extractable).

Our Service Process

• Conduct an initial risk assessment of all primary and secondary contact materials of the customer's product to identify possible extractables and leachables.
• Gather supplier information and design test methods for different materials and products according to industry standards and regulatory requirements.
• Simulate product use conditions and study material chemical stability and release characteristics in different environments.
• Qualitatively and quantitatively analyze the extracted chemical substances to assess the potential risk to human health.
• Determine compliance with safety standards based on test results.
• Ensure that the test results meet the compliance requirements of FDA, USP, ISO and other relevant regulations and standards.

Our Comprehensive Services

We have tailored programs for the testing of pharmaceutical products, container closed component materials, regulatory needs, and product applications, including but not limited to:

• Controlled extraction studies
• Extract analysis
• Headspace for GC-MS for volatile organic leachables
• Liquid injection GC-MS for semi-volatile leachables
• LC-MS for non-volatile leachables
• ICP-MS for inorganic leachables
• Toxicological evaluation
• Leachables method development and validation
• Full validation according to ICH guidelines
• Product leachables testing

Our Service Scope

Extractables and leachables in drugs have become a focus area for the FDA. Factors that need to be considered in the risk assessment of extractable and extractable substances in the pharmaceutical industry include dosage, frequency of administration, and drug dosage form. In addition to the pharmaceutical industry, Protheragen-ING Lab's staff of seasoned chemists have experience with all forms of product processing, packaging and medical devices, including:

• Medical tubing
• Metered dose inhalers
• Process components (filters, bags, tubing)
• Drug delivery pumps (insulin, etc.)
• Bottles, caps, seals
• Single use systems
• Drug delivery patches
• Stents
• Pre-filled syringes

At Protheragen-ING Lab, delivery of extractables and leachables tests includes full extractables reports with all species identified, toxicological assessment of detected extractables, fully validated, ICH-compliant methods for leachables assessment of the drug product, and leachables characterization of stability samples.

Contact us today to learn more about our extractables and leachables testing services. Our team is ready to help you with your extractables and leachables needs.