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The US Pharmacopeia: interfacing chemical metrology with pharmaceutical and compendial science

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Abstract

The United States Pharmacopeial Convention (USP) is an official public standards-setting authority for prescription and over-the-counter medicines and other healthcare products manufactured or sold in the United States. USP’s standards are recognized and used in more than 130 countries around the globe. Over the last decade, USP has worked to advance measurement science for food and drug articles of commerce. Adoption of modern metrologic principles helps ensure that a measurement of one or more property values (attributes) of a food or drug article is acceptable without regard to when (time), where (space), or how (technology) the measurement was taken. The vision of USP is to achieve the international recognition, harmonization, and official acceptance for all USP reference standards based on sound scientific metrological principles. Current hot topics at USP, such as elemental impurities, adulteration, and contamination, as well as counterfeit drugs, are also discussed in this article.

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Acknowledgment

The authors thank Stefan Schuber, PhD, ELS, director of scientific reports at USP, for editorial contributions.

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Authors and Affiliations

  1. United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD, 20852-1790, USA

    William F. Koch & Bei Ma

Authors
  1. William F. Koch
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  2. Bei Ma
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Corresponding author

Correspondence to William F. Koch.

Additional information

When a particular brand or source of a material, instrument, or piece of equipment, or the name of a manufacturer or distributor is mentioned, this identification is furnished solely for informational purposes as a matter of convenience without implication of USP approval, endorsement, or certification.

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Koch, W.F., Ma, B. The US Pharmacopeia: interfacing chemical metrology with pharmaceutical and compendial science. Accred Qual Assur 16, 43–51 (2011). https://doi.org/10.1007/s00769-010-0718-1

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  • DOI: https://doi.org/10.1007/s00769-010-0718-1

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