USP offers a portfolio of solutions to help address quality assurance with globally recognized standards designed to accelerate the pharmaceutical drug development process and increase confidence in the accuracy of analytical results.
This learning hub provides a wealth of information organized into the sections below. Explore the topics by means of accessing the resources that include application notes, white papers, factsheets, and videos—in fact, everything you need to equip yourself with better insights into pharmaceutical quality, testing, and standards.
- Value of a USP Reference Standard
Ensuring medicines meet quality standards is critical to managing pharmaceutical manufacturing risk and reputation. This section explains how to mitigate risks and the essential role of reference standards in ensuring the quality of medicines. - Impurity Control
Identifying and properly controlling impurities are central to maintaining the quality of a drug as it moves from development to manufacture to release and throughout its shelf-life. If drug impurities are determined to be toxic, their presence—even in small amounts—can impact drug safety. Learn how USP’s impurity solutions, like pharmaceutical analytical impurities (PAI) analytical reference materials can help support your impurity-related needs. USP offers resources on regulatory guidance, important considerations for drug substance stress testing and forced degradation, and how to minimize impurity risks in pharma by ensuring safety and regulatory compliance. - Dissolution
When performing dissolution verification testing, a holistic approach is necessary for complete confidence. Mechanical calibration alone cannot capture the full impact of all operational variables, their interactions, and the interaction of the dissolution instrument with the surrounding environment. Learn how to achieve greater confidence in dissolution test accuracy and compliance, and how to fully qualify your dissolution instruments through performance verification testing (PVT). - Robust Polymeric Excipients Profiling
Here you will discover USP’s comprehensive standards and solutions that can help you navigate LG polymer nomenclature and characterization complexities with confidence, ease, and certainty. - Pharmaceutical Packaging Safety
Potential adulteration of drug products by extractable and leachable compounds that enter a drug product from a container or closure system is an area of increasing concern, driving the need for evolving analytical methods. Explore proposed GC-MS and LC-MS methods tested by USP to assist with further evaluation of extractable and leachable analysis of pharmaceutical drug products and packaging.
