Official USP Reference Standards: Metrology concepts, overview, and scientific issues and opportunities

Journal of Pharmaceutical and Biomedical Analysis

Volumn 40, Issue 1, 2006, Pages 3-15

  Williams, Roger L ^a   Alaimo, Lise ^a   Bailey, Mark ^a   Borer, Matthew ^a   Cox, Raymond ^a   Fay, David ^a   Kaster, Gregory ^a   Parris, Reenie ^a   Singer, Jeffrey ^a   Boehlert, Judy P ^a   Cox, Raymond A ^a   Foster, Thomas S ^a   Hanna, Samir A ^a   Kumar, Krishan ^a   Lacroix, Pauline M ^a   Poochikian, Guirag K ^a   Schniepp, Susan J ^a   Sheinin, Eric ^a   Wolff, Manfred E ^a   Workman, Wesley E ^a   Fay, David A ^a   Gomez, Ralph ^a   Gray, Vivian A ^a   Homan, Ruth ^a   Ines, Maria ^a   Kaster, Gregory T ^a   Lee, Judy A ^a   Ribick, Michael ^a   Santoro, R M ^a   Cecil, Todd ^a   Dressman, Shawn ^a   Esker, John ^a   Feyns, L Valentin ^a   Hauck, Walter ^a   Manning, Ronald ^a   Schuber, Stefan ^a   more..

^a UNITED STATES PHARMACOPEIA   (United States)

Author keywords

Metrology; Monographs; Reference Standards; Specifications; United States Pharmacopeia; USP NF

Indexed keywords

EXCIPIENT;

DRUG DETERMINATION; DRUG IMPURITY; DRUG INFORMATION; DRUG NOMENCLATURE; DRUG PACKAGING; DRUG QUALITY; DRUG RESEARCH; MEDICAL LITERATURE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CHEMISTRY, PHARMACEUTICAL; DOSAGE FORMS; DRUG APPROVAL; DRUG COMPOUNDING; DRUG INFORMATION SERVICES; PHARMACEUTICAL PREPARATIONS; PHARMACOPOEIAS; PILOT PROJECTS; QUALITY CONTROL; REFERENCE STANDARDS; SOCIETIES, PHARMACEUTICAL; SOLUBILITY; TABLETS; TERMINOLOGY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 30344448862     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2005.07.017     Document Type: Review

References (26)

1. L. Anderson, and G.J. Higby The Spirit of Voluntarism - A Legacy of Commitment and Contribution: The United States Pharmacopeia 1820-1995 1995 The United States Pharmacopeial Convention, Inc. Rockville, MD
2. H.G. Wolfe, Charles Rice (1841-1901), an immigrant in pharmacy, Paper presented at Joint meeting of American Pharmaceutical Association and American Institute of the History of Pharmacy, April 1949. Jacksonville, FL.
3. B.N. Taylor, and C.E. Kuyatt Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results 1994 National Institute of Standards and Technology Gaithersburg, MD
4. General Chapter 〈11〉 USP Reference Standards. USP 28-NF 23. The United States Pharmacopeial Convention, Inc., Rockville, MD, 2005. p. 2204.
5. W. May, R. Parris, C. Beck, J. Fassett, R. Greenberg, F. Guenther, G. Kramer, S. Wise, T. Gills, J. Colbert, R. Gettings, and B. MacDonald Definitions of Terms and Modes Used at NIST for Value-Assignment of Reference Materials for Chemical Measurement 2000 National Institute of Standards and Technology Special Publication 260-136 Gaithersburg, MD p. 10
6. S.L.R. Ellison M. Rosslein A. Williams EURACHEM/CITAC Guide: Quantifying Uncertainty in Analytical Measurement second ed. 2000 National Institute of Standards and Technology Gaithersburg, MD 9
7. D.L. Deuwer, R.M. Parris, E.W. White, V.W.W. May, and H. Elbaum An Approach to the Metrologically Sound Traceable Assessment of the Chemical Purity of Organic Referenxce Materials 2004 NIST Special Publication 1012, National Institute of Standards and Technology Gaithersburg, MD pp. 3
8. Federal Food, Drug, and Cosmetic Act (Public Law No. 75-717 52 Stat. 1040), 1938.
9. 21 U.S.C. §321(g).
10. General Notices, USP 28-NF 23, United States Pharmacopeia, Rockville, MD, 2005. p. 5.
11. Valentino J.G., Pharm. Technol. 3 (9) (1979) 61-64.
12. Department of Standards Development. Guideline for Submitting Requests for Revision to USP-NF. United States Pharmacopeia, Rockville, MD, 2004. Also available at http://www.usp.org/standards/revisionguideline/index.html (accessed 05/09/05).
13. T. Layloff, M. Nasr, R. Baldwin, M. Caphart, H. Drew, J. Hanig, C. Hoiberg, S. Koepke, G. Lunn, J.T. MacGregor, Y. Mille, E. Murphy, L. Ng, R. Rajagopalan, E. Sheinin, M. Smela, M. Welschenbach, H. Winkle, and R. Williams Pharm. Technol. 24 1 2000 30 42
14. L.T. Grady, and W.M. Heller Headquarters Column. Pharm. Forum. 11 5 1985 620 621
15. International Conference on Harmonization. Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substance and New Drug Products: Chemical Substances, Geneva, Switzerland, 2000.
16. International Conference on Harmonization. Q3A (R): Impurities in New Drug Substances, Geneva, Switzerland, 2000.
17. International Conference on Harmonization. Q3B (R): Impurities in New Drug Products, Geneva, Switzerland, 2000.
18. International Conference on Harmonization. Q3C: Impurities: Residual Solvents, Geneva, Switzerland, 2000.
19. L. Bhattacharyya, H. Pappa, K.A. Russo, E. Sheinin, and R.L. Williams Pharm. Forum. 31 3 2005 960 966
20. IUPAC. Compendium of Analytical Nomenclature, Definitive Rules 1997. ("Orange Book"), third ed. Blackwell, Oxford, 1998.
21. R. Bethem, J. Boison, J. Gale, D. Heller, S. Lehotay, J. Loo, S. Musser, and P. Price J. Stein. J. Am. Soc. Mass Spectrometry 14 2003 528 541
22. T. Fearn, S.A. Fisher, M. Thompson, and S.L.R. Ellison Analyst 127 2002 818 824
23. L. Bhattacharyya, T. Cecil, R. Dabbah, D. Roll, S. Schuber, E.B. Sheinin, and R.L. Williams USP Council of Experts Expert Committee Pharm. Res. 21 10 2004 1725 1731
24. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry (Draft Guidance), ANDAs: Impurities in Drug Substances, Rockville, MD, 2004.
25. W.W. Hauck, T. Foster, E. Sheinin, T. Cecil, W. Brown, M. Marques, and R.L. Williams Pharm. Res. 22 2 2005 182 187
26. ISO. Guide 34 General Requirements for the Competence of Reference Material Producers. second ed. Geneva, Switzerland: ISO Press; 2000:v.