Successful testing and release of small molecule drugs requires accurate and precise analysis using validated methods and well characterized materials. Recognized globally, USP’s independently vetted, science-based documentary and Reference Standards enable manufacturers to operate with a high level of certainty and confidence in their analytical results, saving time and money and reducing risk throughout the drug development process. In a peer reviewed publication, drug manufacturers reported that pharmacopeial standards reduce formulation timelines by 26%, and 90% of them believed pharmacopeial standards simplify work and reduce risk of ANDA rejection.
New! The USP Pipeline provides visibility into all documentary and reference standards in development and published in USP-NF.
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Information & resources
Reference Standards
USP Standards help accelerate the pharmaceutical drug development and manufacturing process and increase confidence in the accuracy of analytical results.
Performance Verification Testing
DPVS–Prednisone Tablets address issues that enhanced mechanical calibration (EMC) alone cannot resolve.
Impurities
Increase certainty in impurity profiling with validated methods, Reference Standards and Materials.
Nitrosamines
USP Standards and other resources help manufacturers address nitrosamines impurities.
USP Donations Program
Accelerate the development of quality standards and protect global public health by contributing information and materials to the USP Donations Program.
Access the USP Store for a comprehensive set of standard solutions, that include Reference Standards, Pharmaceutical Analytical Impurities and Analytical Reference Materials.
Complex generics are a growing category of products that are characterized by complex active ingredients, formulations or routes of delivery.
Learn how USP is helping make complex generics more accessible
USP-NF
Stay informed and get updates on new official text, notices, commentary, errata end more.
Emerging Standards
Shape the Standard, anticipate change and accelerate drug development. USP’s Emerging Standards program is an agile, iterative approach to standards development.
Learn more about Emerging Standards
USP Education
USP resources and educational programs guide you every step of the way to gain knowledge and skills for greater confidence in your pharmaceutical quality testing.