Because they comprise up to 90% of medications, the quality of inactive ingredients (excipients) is critical for a drug to be safe and effective. Our documentary standards provide the appropriate, validated test procedures to establish the identity, purity and quality of excipients, while our reference standards are authentic specimens that have been approved as suitable for use as comparison standards in USP or NF tests and assays. At every step, we're protecting the public's health by helping to prevent poor¬quality medication from entering the marketplace.
In-focus: Get the latest excipient news
Excipient Standards Catalog
USP offers more than 350 expert curated and highly characterized Reference Standards. Explore excipients you can trust.
Essential, Not Optional
Learn how USP safeguards excipient quality.
Achieve unmatched precision
Want advanced methods for phospholipid profiling?
Confident robust profiling
Want robust methods for LG polymer characterization? Explore our solutions.
Novel excipients hub
Want updates on USP’s work on novel excipients? Plus, share your top novel excipient challenges with us.
Featured resources
DEG Tool Kit
Access USP’s free toolkit for measuring and controlling levels of Diethylene Glycol and Ethylene Glycol contamination.
Harmonization of Excipient Standards - Pharmacopeial Discussion Group
Twice a year, USP, the Japanese Pharmacopoeia, and the European Pharmacopoeia convene to carry out the harmonization activities of the Pharmacopeial Discussion Group. Review highlights from the latest meetings.
Excipients 101: An introduction to Excipients
Learn more about excipients and why are they important to ensuring the quality of medicines.
USP Public Policy Position
Excipients: A Blind Spot in Ensuring Medicine Quality and Supply Chain Resilience
Excipient quality issues and shortages have contributed to supply chain disruptions, drug shortages, and adverse patient health outcomes. Enhancing visibility into excipients supply chains is essential to properly focus efforts to prevent or mitigate drug shortages.
Fostering the Use of Novel Excipients in Drug Products
USP supports policies and initiatives to facilitate the introduction and use of novel excipients that encourage increased cooperation and coordination between stakeholders and prioritize regulatory developments to support their use in new therapies and modalities.
