For over 200 years, USP has worked to build trust where it matters most: in the world's medicines, dietary supplements and foods. Through their rigorous science and the public quality standards they set, USP helps protect patient safety and improve the health of people around the world.
USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. USP are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected.
Reference Standards
Not all standards are created equal. We establish primary standards for helping to ensure quality in pharmaceutical development & manufacturing.
To confirm accuracy and reproducibility, USP Reference Standards are rigorously tested and evaluated by multiple independent laboratories including USP, commercial, regulatory, and academic labs. We also provide publicly available, official documentary standards for pharmaceutical ingredients in the USP–NF that link directly with our primary reference standards.
When you use these standards together, you know you’re gaining value beyond the vial. Your peers agree; generic drug manufacturers surveyed believe that pharmacopeial standards:
- Accelerate product development, saving 19% of time, overall, and 31% of time on analytical method development
- Reduce risk of ANDA rejection, according to 90% of respondents
USP currently offers more than 3,500 Reference Standards—highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. USP Reference Standards are specified for use in conducting official USP–NF tests and assays. USP also provides Reference Standards specified in the Food Chemicals Codex as well as authentic substances—high-quality chemical samples—as a service to analytical, clinical, pharmaceutical and research laboratories.
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