The Role of USP Monographs in Stability Testing

  • Karen A. Russo
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)


For drugs, including biologics, and excipients, the US Pharmacopeial Convention’s (USP’s) role in setting public standards generally begins after the Food and Drug Administration (FDA) approval. Working with pharmaceutical manufacturers, FDA, USP staff, and other stakeholders, USP’s Council of Experts develops the public standard, i.e., a drug substance and drug monograph with allied reference materials (Official USP Reference Substances) when needed. The drug substance and product monographs contain tests, procedures, and acceptance criteria (collectively referred to as the specification) for an official article in the United States Pharmacopeia (USP) and excipients monographs are included in National Formulary (NF). Articles in USP–NF are expected to comply with the specification and other requirements until their expiration date in accordance with the adulteration and misbranding provisions of the US Food, Drug & Cosmetic Act, as well as in accordance to USP’s requirements as stated in General Notices (see current USP). Other bodies, e.g., States and other countries may rely on standards in USP–NF. Because USP standards are applicable throughout the shelf-life of a product, they are important for assurance of adequate quality throughout the time that a medicine is available to the patients and consumers.


Dosage Form Drug Substance National Formulary United States Pharmacopeia Public Standard 
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  1. Anderson L, Higby GJ (1995) The spirit of voluntarism: a legacy of commitment and contribution – the United States Pharmacopeia 1820–1995. US Pharmacopeial Convention, Rockville, MDGoogle Scholar
  2. Bhattacharyya L, Cecil T, Dabbah R, Roll D, Schuber S, Sheinin EB, Williams RL, and the USP Council of Experts Executive Committee (2004) The value of USP public standards for therapeutic products. Pharm Res 21:1725–1731. doi:10.1023/B:PHAM.0000045222.01170.4cGoogle Scholar
  3. Hauck WW, Koch W, Abernethy DR, Williams RL (2008) Making sense of trueness, precision, accuracy, and uncertainty. Pharm Forum 34:838–842Google Scholar
  4. International Conference on Harmonization (2003) Q3B (R2) impurities in drug products. Accessed 22 Apr, 2008Google Scholar
  5. US Pharmacopeial Convention (2007) USP guideline for submitting requests for revision to USP–NF. Accessed 22 Apr 2008Google Scholar
  6. US Pharmacopeial Convention (2008) US Pharmacopeia pending monographs guideline. Accessed 22 Apr, 2008Google Scholar
  7. US Pharmacopeial Convention (2009a) USP 32–NF 27, Pharmaceutical Stability <1150>, Validation of Compendial Methods <1225>, and Impurities in Official Articles <1086>. US Pharmacopeial Convention, Rockville, MD, pp. 662–663, 733–736, 546–549Google Scholar
  8. US Pharmacopeial Convention (2009b) USP non-US monographs guideline. Accessed 22 Apr, 2008Google Scholar
  9. Schniepp S (2006) Understanding the United States Pharmacopeia and the National Formulary: demystifying the standards-setting process. Parenteral Drug Association, Bethesda, MDGoogle Scholar
  10. Williams RL, Project Team 4, the 2000–2005 Reference Standards Committee of the USP Council of Experts and Its Advisory Panel, and USP Staff and Consultant (2006). Official USP reference standards: metrology concepts, overview, and scientific issues and opportunities. J Pharm Biomed Anal 40:3–15. doi:10.1016/j.jpba.2005.07.017.Google Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  • Karen A. Russo
    • 1
  1. 1.United States PharmacopeialRockvilleUSA

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