USP <232> and <233>
Elemental Impurity Testing
USP <1663> & USP <1664> E&L Testing
USP <1663> & USP <1664> E&L Testing
USP <1663> and USP <1664> include guidance for assessing risks from extractables and leachables (E&L) in pharmaceutical packaging and delivery systems. The full names of each chapter are:
USP <1663>: Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
USP <1664>: Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
These USP chapters are considered informational, as they describe the justification for carrying out E&L risk assessments, as well as design and execution guidelines for assessment experiments and testing procedures.
Boston Analytical provides extensive expertise in USP <1663> extractables testing and USP <1664> leachables testing, using state-of-the art equipment and processes. Our processes include validation to certify the accuracy of the test. We also specialize in reliable, accurate testing for laboratory and manufacturing settings. Our services help you ensure the safety of patients and other end users, as well as compliance with regulatory standards including cGMP and FDA requirements.
USP <1663> Information and Testing
USP chapter <1663> describes the risks of extractables in pharmaceutical packaging and delivery systems. This chapter includes the definition of extractables, why testing should be carried out, where extractables can occur, and information on testing procedures.
As an informational chapter, USP <1663> does not include standards or acceptable levels for extractables. Boston Analytical offers expertise in testing and assessment of extractables. We can work with you to determine the suitability of your products and equipment for distribution and use.
Extractables are defined as substances or materials in pharmaceutical packaging and delivery systems which may be drawn out of components in harsh or stressful conditions, particularly extreme temperatures or exposure to solvents.
The testing procedures for extractables under USP <1663> thus focus on replicating those conditions and assessing the presence of any compounds or materials that may have been extracted. These substances are then evaluated in order to determine the risk level for end users.
USP <1664> Information and Testing
USP <1664> describes the risks of leachable substances in pharmaceutical packaging. Leachables are defined as materials that “leach” from packaging materials in standard usage conditions, whether or not the materials are subject to extreme or abnormal environments.
Testing for leachables typically involves longer-term assessment of materials under normal or expected conditions. Because pharmaceutical equipment may be stored or shipped for long periods, quality leachable testing is a critical concern in assessing the safety and suitability of products for patient use.
Like USP <1663>, USP <1664> is an informational chapter that outlines the definition and risks of leachables, as well as standard testing rationale and procedures. This chapter does not define acceptable standards for leachable levels. However, Boston Analytical has the expertise to help you properly carry out testing and assess the risks of any substances present in your products in order to keep users safe and remain in compliance with regulatory standards.
With extensive experience and knowledge in laboratory testing, validation, commissioning, decommissioning, and certification, Boston Analytical is your partner of choice for your regulatory and safety compliance needs. We feature the latest testing equipment and maintain up-to-date knowledge on the standards and guidelines that you need to meet all applicable requirements.
In-Process and Lot Release Testing Inquiry Form
If you have a project that requires the expertise and knowledge in In-process & Lot Release Testing that Boston Analytical can provide, please complete the form below: