Herbal Reference Standards

Abstract

This review describes the current definitions and regulatory requirements that apply to reference standards that are used to analyse herbal products. It also describes and discusses the current use of reference substances and reference extracts in the European and United States pharmacopoeias.

reference substances - reference extracts - phytochemical markers - herbal medicinal products - dietary supplements - food supplements - quality control

References

• 1 Reif K, Sievers H, Steffen J-P. The role of chemical reference standards as analytical tools in the quality assessment of botanical materials – a European perspective.  Herbal Gram. 2004;  63 38-43
• 2 Helliwell K. Herbal reference standards.  Pharmeuropa. 2006;  2 235-238
• 3 Veit M, Wissel S. Definitionen und Anforderungen an Referenzstandards in der Arzneimittelprüfung.  Pharm Ind. 2007;  12 1475-1480
• 4 Veit M, Wissel S. Referenzstandards in der Arzneimittellprüfung.  Pharm Ind. 2008;  1 135-138
• 5 Dietary supplements and health education act, Public Law 103–417, 103rd Congress, 1994. Available at www.fda.gov/opacom/laws/DSHEA.html. Accessed November 27, 2008
• 6 Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements; Final Rule, 21 CFR Part 111, 2007. Available at www.cfsan.fda.gov/%7Elrd/fr07625a.html. Accessed November 27, 2008
• 7 Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, guidance document of the Scientific Committee (Question No EFSA‐Q-2005–233), European Food Safety Authority, 2007. Available at www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178717026833.htm. Accessed November 27, 2008
• 8 European Commission request to the European Food Safety Authority for scientific advice on: the community list of permitted health claims pursuant article 13 of regulation 1924/2006 on nutrition and health claims made on foods – terms of reference, EFSA, 2008. Available at www.efsa.europa.eu/cs/BlobServer/General/claims_art13_TOR,3.pdf?ssbinary=true. Accessed November 27, 2008
• 9 European Pharmacopeia Edition 6.2. Available at www.edqm.org. Accessed November 27, 2008
• 10 United States Pharmacopeia – National Formulary. Available at www.uspnf.com. Accessed November 27, 2008
• 11 Note for guidance on good manufacturing practice for active pharmaceutical ingredients (CPMP/ICH/4106/00), ICH Topic Q7, good manufacturing practice for active pharmaceutical ingredients. Available at www.emea.europa.eu/pdfs/human/ich/410600en.pdf. Accessed November 27, 2008
• 12 ISO Guide 30. Terms and definitions used in connection with reference materials. Geneva; International Organisation for Standardization 1992
• 13 ISO Guide 31. Reference materials. Contents of certificates and labels. Geneva; International Organisation for Standardization 2000
• 14 ISO Guide 32. Calibration in analytical chemistry and use of certified reference materials. Geneva; International Organisation for Standardization 1997
• 15 ISO Guide 33. Uses of certified reference materials. Geneva; International Organisation for Standardization 2000
• 16 ISO Guide 34. General requirements for the competence of reference materials producers. Geneva; International Organisation for Standardization 2000
• 17 ISO Guide 35. Reference materials. General and statistical principles for certification. 2006. Geneva; International Organization for Standardization 2006
• 18 Guideline on quality of herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2819/00 Rev 1). Available at www.emea.europa.eu/pdfs/human/qwp/281900en.pdf. Accessed November 27, 2008
• 19 Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products (CPMP/QWP/2820/00 Rev 1). Available at www.emea.europa.eu/pdfs/human/qwp/282000en.pdf. Accessed November 27, 2008
• 20 Guidance for industry. Botanical drug products, U. S. Department of Health and Human Services, Food and Drug Administration. June/2004
• 21 Reflection paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products (EMEA/HMPC/253629/2007). Available at www.emea.europa.eu/pdfs/human/hmpc/25362907enfin.pdf. Accessed January 30, 2009
• 22 NIST/EPA/NIH (NIST 08) Mass Spectral Library. National Institute of Technology. Available at www.nist.gov/srd/nist1a.htm. Accessed November 27, 2008
• 23 Spectral Database for Organic Compounds. National Institute of Advanced Industrial Science and Technology (AIST). Available at riodb01.ibase.aist.go.jp/sdbs/cgi-bin/cre_index.cgi?lang=eng. Accessed November 27, 2008
• 24 ICH Topic Q 2 (R1) Validation of analytical procedures: text and methodology (CPMP/ICH/381/95). 1995. Available from www.emea.europa.eu/pdfs/human/ich/038195en.pdf. Accessed November 27, 2008
• 25 Pauli G, Jaki U, Lankin D, Walter J, Burton I. Quantitative NMR of bioactive natural products. Colegate S, Molyneux R Bioactive natural products. Boca Raton; CRC Press 2008: 113-141
• 26 Diehl B WK, Malz F, Holzgrabe U. Quantitative NMR spectroscopy in the quality evaluation of active pharmaceutical ingredients and excipients.  Spectrosc Eur. 2007;  19 15-19
• 27 Pauli G, Jaki B, Lankin D. Quantitative H NMR: development and potential of a method for natural products analysis.  J Nat Prod. 2005;  68 133-149
• 28 Lopez-Rituerto E, Cabredo S, Lopez M, Avenoza A, Busto J H, Peregrina J M. A thorough study on the use of quantitative ¹H NMR in rioja red wine fermentation process.  J Agric Food Chem. 2009;  57 2112-2118
• 29 Bekiroglu S, Myrberg O, Oestman K, Ek M, Arvidsson T, Rundloef T, Hakkarainen B. Validation of a quantitative NMR method for suspected counterfeit products exemplified on determination of benzethonium chloride in grapefruit seed extracts.  J Pharm Biomed Anal. 2008;  47 958-961
• 30 Mohn T, Cutting B, Ernst B, Hamburger M. Extraction and analysis of intact glucosinolates – a validated pressurized liquid extraction/liquid chromatography – mass spectrometry protocol for Isatis tinctoria, and qualitative analysis of other cruciferous plants.  J Chromatogr A. 2007;  1166 142-151
• 31 Mehr K, John B, Russel D, Avizonis D. Electronic referencing techniques for quantitative NMR: pitfalls and how to avoid them using amplitude-corrected referencing through signal injection.  Anal Chem. 2008;  80 8320-8323
• 32 Quantifying uncertainty in analytical measurement. Eurachem/CITAC Guide CG 4, second edition. Available at www.measurementuncertainty.org/mu/QUAM2000-1.pdf. Accessed November 27, 2008
• 33 Turmeric; Powdered Turmeric; Powdered Turmeric Extract; Curcuminoids; Curcuminoids Capsules; Curcuminoids Tablets; Powdered Soy Isoflavones Extract; Soy Isoflavones Tablets; Soy Isoflavones Capsules. USP Pharmacopoeial Forum 2007 6
• 34 Guggul, Native Guggul Extract, Purified Guggul Extract and Guggul Tablets. USP Pharmacopoeial Forum 2008 4
• 35 Horse-chestnut/horse-chestnut dry extract.  Pharmeuropa. 2008;  20 478-483
• 36 Betz J M. The importance of reference materials to the dietary supplement research and manufacturing communities. AOAC, TDRM.  The Reference Standard Newsletter. 2008;  42 1-3