Evidence map›Paper›PMID 34109550›Full record

ArticleBiological trace element research2022

The Toxicological Risk Assessment of Cu, Mn, and Zn as Essential Elemental Impurities in Herbal Medicinal Products with Valerian Root (Valeriana officinalis L., radix) Available in Polish Pharmacies.

Kamil Jurowski, Maria Fołta, Barbara Tatar, Mehmet Berkoz, Mirosław Krośniak

Open access · hybridAbstract read
In one paragraph

Article in Biological trace element research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 19% of its field
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Metal Content inFoods (Basel, Switzerland) · 2026
    Article
  3. Article
  4. Health Risk Assessment of Metals in Antidiabetic Herbal Preparations: A Safety Screening.Evidence-based complementary and alternative medicine : eCAM · 2024
    Article
  5. Article
  6. Article
  7. Article
  8. Article
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

5 authors at 3 institutions in 2 countries.

Kamil JurowskiInstitute of Medical Studies, Medical College, Rzeszów University, Al. mjr. W. Kopisto 2a , 35-959, Rzeszów, Poland. jurowski.tox@gmail.com.ORCID http://orcid.org/0000-0003-0310-2849
Maria FołtaDepartment of Food Chemistry and Nutrition, Medical College, Jagiellonian University, Medyczna 9, 30-688, Kraków, Poland.
Barbara TatarDepartment of Food Chemistry and Nutrition, Medical College, Jagiellonian University, Medyczna 9, 30-688, Kraków, Poland.
Mehmet BerkozDepartment of Biochemistry, Van Yuzuncu Yil University, Faculty of Pharmacy, 65080, Van, Turkey.
Mirosław KrośniakDepartment of Food Chemistry and Nutrition, Medical College, Jagiellonian University, Medyczna 9, 30-688, Kraków, Poland.
Jagiellonian University · PLUniversity of Rzeszów · PLVan Yüzüncü Yıl Üniversitesi · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The toxicological risk assessment (TRA) of elemental impurities (EI) in especially herbal medicinal products (HMP) is a significant challenge for pharmaceutical industry. In Europe, very popular are traditional HMP with valerian root (Valeriana officinalis L., radix) for relief of mild symptoms of mental stress and to aid sleep. The aim of our unique article is the comprehensive TRA of Cu, Mn, and Zn as EI in HMP with V. officinalis L., radix available in Polish pharmacies. This article is a continuation of our previously conducted studies about TRA of heavy metals (Pb and Cd) in these same samples. Investigated elements were determined by flame atomic absorption spectrometry (F AAS). The values of the correlation coefficients (R > 0.998) confirm the linearity of the applied instrument for precision and accuracy of results. The recoveries, LOD and LOQ values were acceptable. Our results show that all investigated HMP with valerian root available in Polish pharmacies contain Cu (0.16-0.23 mg/L), Mn (0.11-0.76 mg/L), and Zn (0.22-0.48 mg/L) at a very low level. Based on our estimation of EI including single dose (µg/20 mL) and estimated daily intake (µg/day), our results confirm the safety of all pharmaceuticals. To the best of our knowledge, the Cu, Mn, and Zn impurity profile in HMP with V. officinalis L., radix is described for the first time. The applied methodology and results are extremely important from regulatory toxicology point of view (ICH Q3D elemental impurities guideline for pharmaceuticals).

Indexed as

Pharmaceutical PreparationsPharmaciesValerianPlant ExtractsPolandRisk AssessmentZincPharmaceutical PreparationsPlant ExtractsValeriana extractZincElemental impuritiesHerbal medicinal productICH Q3DPDERisk assessmentToxicological analysisValerian root

Identifiers

PMID34109550
PMCPMC8854135
OpenAlexW3167744638

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.