USP Reference Standards
Recognized globally, USP Standards accelerate the pharmaceutical drug development process and increase confidence in the accuracy of analytical results. USP Standards are built on deep science, provide a high degree of analytic rigor and are accepted by regulators around the world. USP Standards support every stage of drug development and manufacturing, saving time and resources which contribute to the acceleration of the development of quality medicines.
The use of USP Standards (Pharmacopeial Reference Standards and Pharmacopeial Documentary Standards Method) enables companies to operate with a high level of certainty and confidence, reducing the risk of incorrect results that could lead to unnecessary batch failures, product delays, and market withdrawals.
Reference Standards Catalog
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. Click below to download the full list.
Download tables with new Reference Standards (RS) released last month, upcoming releases, existing RS with new lots, and more, by clicking here.
New Qualitative RS Update
Selected Qualitative reference standards include a value provided for informational purposes only, in the additional information section of the USP certificate.
Quality Solutions Sheets
A compilation of documentary standards and physical materials related to a drug substance or product – all in one place.
Injectable Drug Formulations
Rising demand for the widespread use of sterile injectable drug formulations is driven by the growth of biopharmaceuticals, enhanced bioavailability, and advancements in drug delivery technologies - all aligned with evolving patient needs.
Overactive Bladder Treatment
Trust USP to support your delivery of innovative and effective OAB treatments to improve patients’ lives.
Atypical Antipsychotics
As global awareness of mental health needs increases, so will the demand for safe, high-quality, and effective generic versions of atypical antipsychotics.
Kinase Inhibitors
Standards and solutions for kinase inhibitors drug development.
Performance Verification Testing
A new standard for Performance Verification Testing (PVT) is now available.
Direct Oral Anticoagulants
Standards and solutions for anticoagulant drug development.
Nitrosamines
USP offers a growing catalog of Nitrosamine impurities.