USP High Resolution Mass Spectrometry Extractables Testing
The USP High Resolution Mass Spectrometry (HRMS) Extractables Testing is a critical analytical service designed to meet the stringent requirements of pharmaceutical and biopharmaceutical industries. This testing ensures that all extractable materials from packaging, containers, or other contact surfaces do not pose risks to patient safety during drug formulation and delivery.
The USP 1654 chapter outlines specific criteria for identifying and quantifying extractables in pharmaceutical products, emphasizing the importance of accurate detection methods. High Resolution Mass Spectrometry (HRMS) provides unparalleled sensitivity and selectivity compared to traditional analytical techniques like GC-MS or LC-MS, making it ideal for this purpose.
Our laboratory uses state-of-the-art equipment such as Waters UPLC coupled with Bruker Xevio Q Exactive HRMS to perform these tests. The system allows us to identify even trace amounts of compounds that might leach out into a drug product during storage or use, ensuring compliance with regulatory standards.
Compliance officers and quality managers rely on this testing method because it offers precise identification capabilities which help in understanding potential risks associated with packaging materials. For R&D engineers, this service ensures they can design safe products from the outset by identifying problematic extractables early in development stages.
In addition to regulatory compliance, HRMS also supports lifecycle management of pharmaceuticals by monitoring changes over time as new formulations are introduced or old ones reformulated. This proactive approach helps minimize recalls and product liability issues down the line.
For procurement teams looking into sourcing materials for future projects, this service provides valuable insights into material compatibility with different types of containers and closures. It allows them to make informed decisions about which suppliers provide safe and reliable packaging solutions.
Benefits
- Ensures compliance with USP 1654 standards for extractables testing in pharmaceuticals.
- Provides accurate identification of even trace amounts of potential contaminants.
- Supports lifecycle management through continuous monitoring of materials used in drug delivery systems.
- Aids in designing safer products by identifying problematic extractables early in the development process.
- Facilitates informed decisions regarding packaging material selection during procurement processes.
Customer Impact and Satisfaction
By offering USP HRMS Extractables Testing, our customers gain confidence that their products meet the highest quality standards required by regulatory bodies. This service enhances brand reputation as it demonstrates commitment to patient safety.
- Achieves peace of mind for compliance officers who know they are adhering strictly to regulations.
- Enables quality managers to maintain consistency in product quality across all stages of production.
- Supports R&D engineers in creating safer, more effective pharmaceutical products.
- Makes procurement teams better equipped to choose reliable suppliers for packaging materials.
Environmental and Sustainability Contributions
The USP HRMS Extractables Testing plays a crucial role in promoting sustainability within the pharmaceutical industry. By identifying potential risks early, it helps prevent unintended environmental impacts from leachable compounds that could end up in water systems or soil.
This service supports sustainable practices by enabling companies to make environmentally friendly choices regarding their packaging materials. It encourages the use of less harmful substances and promotes lifecycle thinking which benefits not only human health but also planetary well-being.
