Pace Analytical Life Sciences has developed a comprehensive approach towards extractable leachable testing. These studies are designed to identify extractables, which are compounds that can be extracted from a component under extreme conditions, and leachables, which are compounds that leach into a drug product from a component that is in direct contact with the drug product under normal conditions. Extractables and Leachables may be composed of both organic substances and inorganic substances typically coming from plastic components, elastomers, coatings, accelerants, antioxidants, inks and vulcanizing agents. Extractable leachable testing is particularly relevant to pharmaceutical packaging and medical device packaging where packaging safety and packaging toxicology is being scrutinized. Extractable leachable testing is important in the medical device industry when biocompatibility testing and material toxicology is being evaluated.
Our approach towards extractables testing is to first characterize all of the extractable components that can be 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 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 and 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. When we have identified the possible extractable materials from the component, we 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 identified during the extractables phase 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.
Our extractables and leachables testing program utilizes the following analytical instrumentation:
Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that their extractables and leachables testing are successfully executed.
We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.
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