Type of Posting: General Chapter Prospectus
Posting Date: 24–Sep–2021
Expert Committees: Non-Botanical Dietary Supplements (NBDS) and Botanical Dietary Supplements and Herbal Medicines (BDSHM)
Input Deadline: 24–Oct–2021
Proposed New Title: <2760> Impurities in Dietary Ingredients and Dietary Supplements
Suggested Audience: Suppliers of non-botanical and botanical dietary ingredients, dietary supplement manufacturers, and testing laboratories.
Estimated Proposal PF: 48(5) [Sept.-Oct. 2022]
Background and objectives: Specifications for impurities are critical quality attributes of dietary ingredients and dietary supplements because they have the potential to affect the safety of supplements. Impurities include substances that can appear in dietary supplements through various routes. They can occur naturally as a result of their presence in the ground, water or air in the location from which materials are sourced, be added intentionally or introduced inadvertently as part of a product’s synthesis, harvest, extraction, or manufacturing. While manufacturers have to ensure the quality and consistency of ingredients that go into a final product, they must also employ measures for the proper control of unwanted impurities in dietary ingredients and dietary supplements. The fact that DS products and ingredients often stem from multiple and/or inhomogeneous sources, both domestic and non-domestic, leads to increased concerns for quality control, particularly with regard to impurities. Applying modern and scientifically sound methods and quality standards will help protect both manufacturers and—more importantly—consumers from impurity-related product quality issues. For a time, USP’s General Chapter <1086> Impurities in Drug Substances and Drug Products was applicable to dietary ingredients and dietary supplements. This changed in May 2021, when this chapter was revised to concentrate on drug substances and drug products and to contain references to ICH guidelines, which collectively make <1086> inappropriate for dietary ingredients and dietary supplements. Hence, the BDSHM and NBDS ECs recommended a new general informational chapter to be established that is dedicated to impurities in dietary ingredients and dietary supplements.
Preliminary outline: The following sections are proposed to be included in the General Chapter
- Sources of impurities
- A structured definition of impurities in DSs
- Suggestions to control impurities
- Suitable analytical techniques for the identification and quantification of impurities
Anticipated activities: USP is requesting early input from stakeholders on this newly proposed informational General Chapter <2760> Impurities in Dietary Ingredients and Dietary Supplements which is planned to be published for comments in Pharmacopeial Forum.
Contact: Binu Koshy, Senior Scientist II (301-692-3672, email@example.com)