USP Reference Standards
USP currently offers more than 3,100 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.
USP's Reference Standards are used in more than 140 countries around the world. USP also collaborates with the World Health Organization in its program to provide international biological standards and chemical reference materials for antibiotics, biologics, and chemotherapeutic agents. Some items are standardized in terms of the corresponding international standards.
Certified Reference Materials (CRMs)—A New Type of USP Reference Standard
USP's Reference Standard portfolio now includes CRMs, which are Reference Standards that have undergone additional metrologically based testing and statistical analysis to meet both USP's stringent criteria and guidelines established by the International Organization for Standardization (ISO). Learn more about CRMs.
- Official recognition, can help demonstrate compliance—USP Reference Standards that are based directly on official monographs in the USP–NF—whose standards and procedures are enforceable by the U.S. Food and Drug Administration (FDA)—are recognized as official standards in the U.S., and their use is effective in demonstrating compliance with statutory requirements.
- Collaboratively tested—USP Reference Standards are established through a collaborative quality testing process that involves at least three independent labs. Learn more about the development process.
- Cost- and time-saving resource—USP Reference Standards offer a convenient, quality-tested alternative that can help you save costs and resources associated with developing in-house reference materials
- Stocked and ready to ship! USP is proud of its 99% availability rate. USP also offers same-day shipping for applicable orders!
USP Reference Standards are used to demonstrate identity, strength, purity, and quality for medicines, dietary supplements, and food ingredients. Common applications include
- Limit tests for impurities or related compounds
- Assays for drug substances and for formulations
- System suitability tests
- Chromatographic and spectrophotometric procedures
- Performance verification tests (e.g., particle count, melting point, and standardization of titrants) as calibrators, blanks, and controls