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.
The results are in
Read the Pharmaceutical Technology article on the results of USP’s Novel Excipients survey and learn about the challenges drug formulators face in developing innovative therapeutics.
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.
Why Excipients Are Important Now and in the Future
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.
When Variability in Excipient Quality is and isn’t Acceptable
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.
Risk Assessment and Sourcing Strategies for APIs and Excipients
Download a poster or view a guided video with more information on how USP’s Ingredient Verification Programs can help you.