Evidence map›Paper›PMID 41226233›Full record

ReviewMolecules (Basel, Switzerland)2025

Rethinking Synthetic Berberine in Nutraceuticals: Nitrosamine Risks, Regulatory Oversight, and Safer Alternatives.

Anil Kumar Meher, Akli Zarouri, Manish Kumar

Abstract readReview
In one paragraph

Review in Molecules (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Anil Kumar MeherDepartment of Bioproducts and Biosystems Engineering, University of Minnesota, St. Paul, MN 55108, USA.ORCID 0000-0002-1726-2424
Akli ZarouriDepartment of Bioproducts and Biosystems Engineering, University of Minnesota, St. Paul, MN 55108, USA.
Manish KumarAmity Institute of Biotechnology, Amity University Noida, Noida 201 303, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Berberine hydrochloride, a bioactive isoquinoline alkaloid with metabolic, lipid-lowering, and antimicrobial properties, is increasingly synthesized for nutraceutical applications due to its high yield and, therefore, cost-effectiveness. However, synthetic production can raise significant safety concerns, particularly regarding potentially toxic residuals generated during chemical process. A primary concern is the formation of nitrosamines, a class of genotoxic impurities associated with the use of secondary amines, nitrites, and strong acids in synthetic processes. This article examines the reported synthetic routes for berberine hydrochloride, with emphasis on the use of toxic reagents and intermediates that, if not completely consumed or effectively removed during synthesis process, may persist as impurities in the final product. In contrast, berberine obtained with aqueous botanical extraction avoids such hazardous synthetic precursors and retains co-occurring alkaloids, offering a cleaner safety profile and potential synergistic benefits.

Indexed as

BerberineDietary SupplementsNitrosaminesHumansBerberineNitrosaminesberberine hydrochlorideDSHEA 1994ICH M7ICH Q3C (R8)nitrosamine impuritiesresidual solventssynthetic nutraceuticals

Identifiers

PMID41226233
PMCPMC12608899

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.