{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T11:47:15Z","timestamp":1740138435013,"version":"3.37.3"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T00:00:00Z","timestamp":1628553600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T00:00:00Z","timestamp":1628553600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Biol Trace Elem Res"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Scientific reports about elemental impurities in final pharmaceutical products are essential from a regulatory point of view; unfortunately, there is a lack of studies about this important toxicological topic. The aim of our short communication was determination of total Cr impurities in traditional herbal medicinal products (THMP) with Thymi herba (<jats:italic>Thymus vulgaris<\/jats:italic> L. and <jats:italic>Thymus zygis<\/jats:italic> L.) available in Polish pharmacies (<jats:italic>n<\/jats:italic>\u2009=\u20096, because only six manufacturers produce this kind of pharmaceutical products in Poland). The total content of Cr impurities was determined by atomic absorption spectrometry using electrothermal atomization (ETAAS). Applied comprehensive toxicological risk assessment was based on three main tiers: Tier 1, the comparison of raw results as total Cr impurities profile (metal per L of THMP) with ICH Q3D guideline standards; Tier 2, the estimation of total Cr exposure with a single dose; and Tier 3, the estimation of total Cr daily exposure. We confirmed that total Cr impurities were present in all analyzed THMP with thymi herba (the observed level was below 6.0\u00a0\u00b5g\/L). Total Cr concentration in a single dose can be deceptively high in comparison to the raw results but is not a threat to patients (20.15\u201363.45\u00a0ng\/single dose). Moreover, the estimation of total Cr daily exposure shows that all analyzed THMP are characterized by daily dose (40.30\u2013181.41\u00a0ng\/day) below PDE value (10,700\u00a0mg\/day); hence, all products meet the standards of ICH Q3D elemental impurities guideline.<\/jats:p>","DOI":"10.1007\/s12011-021-02864-2","type":"journal-article","created":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T01:10:09Z","timestamp":1628557809000},"page":"2983-2988","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The Comprehensive Toxicological Assessment of Total Chromium Impurities in Traditional Herbal Medicinal Product with Thymi herba (Thymus vulgaris L. and Thymus zygis L.) Available in Pharmacies in Poland: Short Communication"],"prefix":"10.1007","volume":"200","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0310-2849","authenticated-orcid":false,"given":"Kamil","family":"Jurowski","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Fo\u0142ta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Tatar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miros\u0142aw","family":"Kro\u015bniak","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,8,10]]},"reference":[{"key":"2864_CR1","unstructured":"EMA\/HMPC\/342332\/2013, Committee on Herbal Medicinal Products (HMPC), Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herb, Available 26.06.2021 at https:\/\/www.ema.europa.eu\/en\/documents\/herbal-monograph\/final-community-herbal-monograph-thymus-vulgaris-l-thymus-zygis-l-herba_en.pdf. Accessed 26 June 2021"},{"key":"2864_CR2","unstructured":"EMA\/HMPC\/342334\/2013, Committee on Herbal Medicinal Products (HMPC), Assessment report on Thymus vulgaris L., vulgaris zygis L., herba, Available 26.06.2021 at https:\/\/www.ema.europa.eu\/en\/documents\/herbal-report\/final-assessment-report-thymus-vulgaris-l-vulgaris-zygis-l-herba_en.pdf. Accessed 26 June 2021"},{"issue":"3","key":"2864_CR3","doi-asserted-by":"publisher","first-page":"1209","DOI":"10.1016\/j.foodchem.2007.02.030","volume":"105","author":"R Kov\u00e1cs","year":"2007","unstructured":"Kov\u00e1cs R, B\u00e9ni \u00c1, Karosi R, S\u00f3gor C, Posta J (2007) Investigation of chromium content in foodstuffs and nutrition supplements by GFAAS and determination of changing Cr(III) to Cr(VI) during baking and toasting bread. Food Chem 105(3):1209\u20131213. https:\/\/doi.org\/10.1016\/j.foodchem.2007.02.030","journal-title":"Food Chem"},{"key":"2864_CR4","volume-title":"The chromium program","author":"JA Fischer","year":"1990","unstructured":"Fischer JA (1990) The chromium program. Harper and Row Publishers, New York"},{"key":"2864_CR5","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1016\/S0048-9697(99)00467-2","volume":"247","author":"M Garcia","year":"2000","unstructured":"Garcia M, Cabrera C (2000) Chromium levels in spices and aromatic herbs. Sci Environ 247:51\u201356. https:\/\/doi.org\/10.1016\/S0048-9697(99)00467-2","journal-title":"Sci Environ"},{"issue":"1\u20132","key":"2864_CR6","doi-asserted-by":"publisher","first-page":"14","DOI":"10.17628\/ECB.2012.1.14-21","volume":"1","author":"K Szentmih\u00e1lyia","year":"2012","unstructured":"Szentmih\u00e1lyia K, Maya Z, Then M, Hajd\u00fa M, B\u00f6sz\u00f6rm\u00e9nyi A, Bal\u00e1zs A, Sz\u0151ke \u00c9 (2012) Metal elements, organic agents in a herbal remedy, species thymi composita, and its drug constituents. Eur Chem Bull 1(1\u20132):14\u201321. https:\/\/doi.org\/10.17628\/ECB.2012.1.14-21","journal-title":"Eur Chem Bull"},{"issue":"12","key":"2864_CR7","doi-asserted-by":"publisher","first-page":"2212","DOI":"10.3945\/jn.117.255901","volume":"147","author":"JB Vincent","year":"2017","unstructured":"Vincent JB (2017) New evidence against chromium as an essential trace element. J Nutr 147(12):2212\u20132219. https:\/\/doi.org\/10.3945\/jn.117.255901","journal-title":"J Nutr"},{"key":"2864_CR8","first-page":"221","volume":"380","author":"RA Anderson","year":"1993","unstructured":"Anderson RA (1993) Recent advances in the clinical and biochemical effects of chromium deficiency. Prog Clin Biol Res 380:221\u2013234","journal-title":"Prog Clin Biol Res"},{"issue":"1 Suppl. l","key":"2864_CR9","first-page":"83","volume":"11","author":"RA Anderson","year":"1995","unstructured":"Anderson RA (1995) Chromium and parenteral nutrition. Nutrition 11(1 Suppl. l):83\u201386","journal-title":"Nutrition"},{"issue":"3","key":"2864_CR10","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1007\/s40572-015-0054-z","volume":"2","author":"H Sun","year":"2015","unstructured":"Sun H, Brocato J, Costa M (2015) Oral chromium exposure and toxicity. 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