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.
Working with Novel Excipients?
Visit our new information hub on novel excipients and access information, resources, and updates on USP's work on standards for novel excipients. Also, while you are there, share with us your current challenges, where USP may be able to help you either in developing or working with novel excipients.
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.