Extractables & Leachables Testing

Infinity Laboratories provides a one-stop solution for extractables and leachables (E&L) studies to identify potentially harmful contaminants within your pharmaceutical drug product or medical device. Without proper extractable and leachable evaluation, unknown chemicals and compounds can present serious risks for pharmaceutical, medical device, and combination product patients.

What Are Extractables & Leachables?

Extractables and leachables are impurities within elastomeric and plastic materials that can contaminate a packaged pharmaceutical drug product or medical device.

Extractables are compounds which can be pulled out of a container or product when exposed to extreme solvents and/or conditions such as elevated temperatures. 

Leachables originate in container closures and seep into a finished product and/or patient over time. Leachables can affect products under standard conditions, but can be commonly traced to monomers, polymer additives, or release agents in the manufacturing process.

Identifying Risk Through Rigorous Investigation

Extractables and leachables can pose significant risk to patients and must be identified and mitigated through E&L studies. Infinity provides the highest quality assays, all of which leverage standards and guidelines set by compendial organizations, including the FDA, ISO, ICH, and the US, European, and Japanese pharmacopeias.

Extractables and leachables represent contaminates within a pharmaceutical drug product or medical device. E&L studies identify the presence or absence of impurities by investigating undesirable outcomes due to:

  • Interaction between a container closure and drug product
  • Impact of solvent(s) used during manufacturing processes
  • A drug delivery system and drug product interaction
  • An implantable medical device interaction with the human body
  • Interactions among materials in the same medical device
  • Impact of elevated temperatures and extraction solvents

Extractables & Leachables Testing Services

Infinity provides comprehensive E&L testing services to meet quality and safety standards established for pharmaceutical, Class II and Class III medical devices, as well as combination drug products.

Elemental Impurities

Standard: USP <232>, USP <233>

Methods and Limits to determine that the presence and concentration of elemental impurities within a product fall within harmonized guidelines.

Impurity Identification

Standard: USP <476>, USP <1086>

Tests for impurities and acceptable impurity limits in medical devices or pharmaceutical products.

Material Compatibility

Standard: Product dependent

Seeks to understand whether or not the different component materials in a medical device, including a drug component, can negatively interact with each other and impact the performance or safety of the overall device.

Plastic Components & Systems

Standard: USP <665>, USP <1665>

Tests to characterize and qualify plastic components for extractables and process equipment-related leachables (PERLs).

Plastic Packaging Systems & Materials of Construction

Standard: USP <661>

Identification, characterization, and physiochemical testing of high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), polyethylene terephthalate G (PETG), and other polymers.

Plastic Materials of Construction and Plastic Packaging Systems for Pharmaceutical Use

Standard: USP <661.1> and USP <661.2>

Extending USP <661>, these tests comply with more rigorous standards that demonstrate that a polymer raw material within primary packaging that comes in contact with the pharmaceutical product and any relevant secondary packaging is well-characterized and suitable for its intended use.

Single-Use Bioprocessing Systems Extractables & Leachables

Standard: USP <665>, USP <1665>, BioPhorum Operations Group (BPOG) Protocol

BPOG protocol outlines the procedures needed to meet expectations outlined in pharmacopeia extractables and leachables standards. Generated data allows developments to compare product characterization data from multiple single-use system vendors.

Bioabsorbable Polymers

Standard: ASTM F1635

Characterization of the properties and degradation profiles of bioabsorbable medical-grade polymers, components, and devices. 

Chemical Characterization

Standard: ISO 10993

ISO 10993 chemical characterization studies are conducted on medical devices to provide ISO 10993-compliant biocompatibility data for regulatory filings. Studies are constructed around ISO 10993-12 (sample preparation) and ISO 10993-18 (chemical characterization) standards.

Impurity Identification

Standard: USP <1086>, USP <476>

Impurity identification and impurity characterization under FDA and ICH guidelines. Available techniques include chromatography, spectroscopy, and microscopy.

Material Compatibility

Standard: ISO 10993

Seeks to understand whether or not the different component materials in a medical device, including a drug component, can negatively interact with each other and impact the performance or safety of the overall device.

Medical Device Extractables & Leachables

Standard: ISO 10993 Chemical Characterization Testing

Set of methods to characterize complex chemical interactions in medical device materials (polymers, metals, ceramics, and composites) to characterize extractables and leachables properly.

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