Skip to Main Content

Pace Analytical Life Sciences (PLS) has developed a comprehensive approach toward extractable and leachable testing. These studies identify extractables, compounds that can be extracted from a component under exaggerated conditions, and leachables, compounds that leach from a container closure in direct contact with the drug product under normal use conditions.

Extractables and leachables may include both organic substances and inorganic compounds, typically coming from container closure systems of delivery devices which may include additives such as, elastomers, coatings, accelerants, antioxidants, inks, and vulcanizing agents. Additionally, extractables can be formed from degradation products from temperature, absorption, hydrolysis, oxidation, corrosion or dissolution, or from the process itself like mold release agents and anti-static and anti-stick agents.

Extractable and leachable testing is particularly relevant to biopharmaceutical, pharmaceutical and medical device packaging where safety and packaging toxicology is being scrutinized.  Leachables in API can affect the safety and efficacy of the drug product delivered to patients.

Download Extractables/Leachables literature.

We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025 accredited.

Extractables & Leachables Approach

Our approach towards extractables testing is to subject a container closure system to worst-case conditions, and then characterize the components that are extracted out of a material following a controlled extraction study. In general, we extract the component in polar solvents, non-polar solvents and water and also heat for a specified amount of time. These extracts are then analyzed using the following techniques:

  • High performance liquid chromatography-photo diode array detection-mass spectrometry (HPLC-PDA-MS) to identify organic (semi-volatile) material from the component
  • Gas chromatography-mass spectrometry (GC-MS) to identify organic (volatile) material from the component
  • Inductively coupled plasma-optical emission spectroscopy (ICP-OES) or inductively coupled plasma-mass spectrometry (ICP-MS) to identify metals from the component
  • Ion Chromatography (IC) can also be used in some situations

We then optimize and validate the analytical method for these compounds of concern.

Once we have analytical methods in place to determine the possible extractables from a component, we can conduct leachable studies. Typically leachable testing is performed on drug product that has been in contact with the components for an extended length of time under normal use conditions. If samples are not available we can stress the drug product and the component under appropriate conditions to generate the leachables. The leachables found may be the same compounds as those that were identified during the extractables phase of the study, or they may be different than those materials due to the interaction of the drug product with the component. All of the major compounds and target compounds that do not have their origins in the drug substance or in any excipients are identified and quantified.

Extractables & Leachables Instrumentation

Our extractables and leachables testing program utilizes the following analytical instrumentation:

  • High Performance Liquid Chromatography (HPLC)
    • Ultraviolet (UV) detection
    • Mass Spectrometer (MS) detection
    • Dual Mass Spectrometer (MS / MS) detection
    • Refractive Index (RI)
  • Gas Chromatography (GC)
    • Flame-Ionization detection (FID)
    • Mass Spectrometer (MS) detection
    • High-Resolution Mass Spectrometer (MS) detection
  • Fourier Transform Infra-red Spectrophotometry (FTIR)
    • Attenuated Total Reflectance (ATR)
  • Ion Chromatography (IC)
    • Anion system
    • Cation system
  • Elemental Metals by Inductively Coupled Plasma (ICP) and Atomic Emission Spectroscopy (AES)

Interested In Life Sciences? Take the Next Step.

When you’re ready to learn more about what Pace can do for you, we’re here with answers to all your questions.