USP Reference Standards

USP Reference Standards

Not all standards are created equal. We establish primary standards for helping to ensure quality in pharmaceutical development and manufacturing. To confirm accuracy and reproducibility, USP Reference Standards are rigorously tested and evaluated by multiple independent laboratories including USP, commercial, regulatory, and academic labs. We also provide publicly available, official documentary standards for pharmaceutical ingredients in the USP–NF that link directly with our primary reference standards.

When you use these standards together, you know you’re gaining value beyond the vial. Your peers agree; generic drug manufacturers surveyed believe that pharmacopeial standards:

  • Accelerate product development, saving 19% of time, overall, and 31% of time on analytical method development
  • Reduce risk of ANDA rejection, according to 90% of respondents

Recognized globally, USP Standards accelerate the pharmaceutical drug development process and increase confidence in the accuracy of analytical results. USP Standards are built on deep science, provide a high degree of analytic rigor and are accepted by regulators around the world. USP Standards support every stage of drug development and manufacturing, saving time and resources which contribute to the acceleration of the development of quality medicines.

The use of USP Standards (Pharmacopeial Reference Standards and Pharmacopeial Documentary Standards Method) enables companies to operate with a high level of certainty and confidence, reducing the risk of incorrect results that could lead to unnecessary batch failures, product delays, and market withdrawals.

With USP Reference Standards you’re getting value beyond the vial. Feel confident that you’ve made the best decision.

See the entire reference standards catalog
See the entire Reference Standards catalog
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Additional Resources

new usp reference standards
New and upcoming releases
quality solutions sheets
Quality Solutions Sheets

New reference standards, new materials, recent monographs, and all the newest releases at USP—all in one place.

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