Pharmacopeial Standards for the Quality Control of Botanical Dietary Supplements in the United States-Reference-Cited by-同舟云学术

Pharmacopeial Standards for the Quality Control of Botanical Dietary Supplements in the United States

Published:2021-10-26 Issue: Volume: Page:1-20
ISSN:1939-0211
Container-title:Journal of Dietary Supplements
language:en
Short-container-title:Journal of Dietary Supplements

Author:

Sarma Nandakumara¹,Upton Roy²,Rose Ulrich³,Guo De-an⁴,Marles Robin⁵,Khan Ikhlas⁶,Giancaspro Gabriel¹

Affiliation:

1. United States Pharmacopeial Convention (USP), Rockville, MD, USA

2. American Herbal Pharmacopoeia, Scotts Valley, CA, USA

3. European Pharmacopoeia, European Directorate for Quality of Medicines and Healthcare, Strasbourg, France

4. Shanghai Institute of Materia Medica, Shanghai, China

5. USP Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, USA

6. National Center for Natural Products Research, University of Mississippi, University, MS, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Nutrition and Dietetics,Food Science

Link

https://www.tandfonline.com/doi/pdf/10.1080/19390211.2021.1990171

Reference17 articles.

1. WHO. Good pharmacopeial practices. Draft chapter on monographs on herbal medicines; 2017 [accessed 2021 Sep 10]. Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/GPhP-HerbalsChapter_QAS15-621_Rev4-07_09_2017.pdf?ua=1.

2. FDA. Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements; Final rule. Title 21 Code of Federal Regulations Part 111, §§ 111.1-111.610 (Revised April 1, 2011); 2007 [accessed 2021 Sep 10]. Available from: http://edocket.access.gpo.gov/2007/07-3039.htm.

3. ICH. ICH Topic Q 6 A. Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances; 2000 [accessed 2021 Sep 10]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-6-test-procedures-acceptance-criteria-new-drug-substances-new-drug-products-chemical_en.pdf.

4. Dietary supplements quality analysis tools from the United States Pharmacopeia

5. Quality specifications for articles of botanical origin from the United States Pharmacopeia

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