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.
Get answers to questions about excipient characterization. Watch videos from a live presentation at the AAPS 2017 Annual Meeting by USP Senior Scientific Liaison, Dr. Galina Holloway.
View highlights from the February 2017 USP-FDA workshop on excipients and explore the relationship between excipients and new technologies such as Continuous Manufacturing and Novel Delivery systems.
The ingredients on a drug product label typically include one, maybe two, active pharmaceutical ingredients (APIs). The rest of the list is comprised of “inactive” ingredients which in reality are far from inactive.
Download a poster or view a guided video with more information on how USP’s Ingredient Verification Programs can help you.