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Everything that goes into a medication serves an important purpose. Inactive ingredients are critical for a drug to be effective, making up to 90% of the medication. However, they can also cause great harm if their quality is poor. By creating standards for excipients, we play a key role in ensuring the purity of the whole drug. Our documentary standards set guidelines for quality in manufacturing, while our reference standards help manufacturers verify the quality of their excipient supply. At every step, we’re protecting the public’s health by helping to prevent poor-quality medication from entering the marketplace.

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Why Excipient Quality Matters

Excipients impact the effectiveness of drugs,
monographs, and reference standards are needed to
address their quality. USP is working with partners
to help ensure excipient quality and protect and
improve the public’s health.


Frequently Asked Questions

  • What is a General Chapter?
  • How does USP define and
    characterize excipients?
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Get Involved

Make your contribution to
global public health. USP needs
your help creating quality standards
for excipients.

Provide input on new and revised
excipient standards proposed in
Pharmacopeial Forum.