Extractables and leachables are chemicals that can be extracted from a product such as a syringe and deposited into the product it is housing. This can be either in the presence of a solvent or through direct contact over an extended period of time. An extractable and leachable study is a key part of quality control particularly in the production of drugs in contact with plastic (such as syringes).
Most materials that are used in food or pharmaceutical applications have been specifically designed to decrease the presence of extractables and leachables. Despite this, it’s important to ensure that materials are tested not only at the beginning of the product lifecycle but also as changes to materials or processes are made to avoid health and safety issues.
Detecting Extractables and Leachables
There are a variety of analytical methods which can identify extractables and leachables. Volatile organic compounds are often identified using headspace GC-MS. Semi-volatile and non-volatile organic compounds are usually identified by employing high-resolution accurate mass GC-MS and LC-MS respectively.
Toxicologists define the analytical evaluation threshold above which an extractable of leachable must be reported for toxicological evaluation. Reference standards are then employed to calculate an estimated concentration of the identified compounds and to determine which are above the threshold.
Extractables and Leachables in Syringes
Pre-filled syringes are being increasingly used as a packaging and delivery system for pharmaceutical drug products. Pre-filled syringes need to adhere to quality and suitability standards and it is critical that they are compatible with the drug product being housed.
There are a range of important ways in which pre-filled syringes and drug products can interact. Extractables and leachables in syringes can migrate into the drug product impacting safety, efficacy, physical viability and stability. Leachables may have a toxicological impact, causing serious harm to the patient or reducing the efficacy of the drug products.
Importance of Testing Extractables and Leachables
The issues caused by extractables and leachables in syringes can be detrimental to human health. This is why it is of critical importance that extractables and leachables testing is carried out on drug products and delivery systems prior to their use.
Designing an extractable and leachable study requires an in-depth understanding of the materials that are used in the device and the drug that it will house. The analytical team must have expertise in identifying unknown compounds to adequately carry out the correct techniques for identification.
The performance of extractables and leachables testing must be supported by the use of stringent quality control measures.
At Jordi Labs, we specialize in the analysis of plastics such as those used for medical syringes. We have the breadth of experience and regulatory knowledge required to successfully conduct extractables and leachables studies. To find out more, contact us today.