USP Reference Standards: 5 Tools You Should Know About
Reference Standards from the United States Pharmacopeial Convention (USP) are highly characterized chemical specimens—pure materials or mixtures of chemicals that have been tested in multiple laboratories—intended for quality control use in conducting assays and tests in USP’s documentary standards for drugs in the United States Pharmacopeia–National Formulary (USP–NF), for dietary supplements in the USP–NF and Dietary Supplements Compendium, and for foods in the Food Chemicals Codex. They can help ensure compliance with the official, FDA-enforceable quality requirements in the USP–NF. USP Reference Standards also lend themselves to other applications, including measurements required to obtain accurate and reproducible results in modern chromatographic and spectrophotometric methods.
USP currently offers more than 3,500 Reference Standards, including materials for drug substances, biologics, excipients, dietary supplements, food ingredients, impurities, degradation products, reagents, and performance verification standards.
To help users of USP Reference Standards locate and apply materials relevant to their work, USP offers these convenient tools and resources:
1. Online Catalog: A complete listing of USP Reference Standards along with lot, date, and ordering information is available online in downloadable XLS and PDF formats. Listings are updated daily to ensure you have current and accurate information.
2. Frequently Asked Questions: The Reference Standards FAQs webpage offers answers to commonly asked user questions, including queries about technical data sheets, labeled value (purity/potency), use and application, shipping, availability and validity.
3. Usage and Storage Information: This guidance provides important information regarding suitability for use, understanding directions on the label and in USP–NF, storage, weighing, drying and dissolution—PVT ranges.
4. Safety Data Sheets Online: This online searchable index lets you download, save and print safety data sheets for the entire catalog of USP Reference Standards.
5. Notices and Information on New or Upcoming Reference Standards Releases:
- Reference Standards Under Development: View a list of never-before-released Reference Standards currently under development at USP and their anticipated release dates
- Notification of New Releases: Sign up to receive an email when a new ever-before-released Reference Standard becomes available.
- Monthly E-Mail Notice: Our monthly email notice features important Reference Standards information including the estimated availability for out of stock items, items with recent or pending valid use dates, and helpful tips.