{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T02:29:37Z","timestamp":1791685777034,"version":"4.3.4"},"reference-count":48,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2010,3,9]],"date-time":"2010-03-09T00:00:00Z","timestamp":1268092800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharm Res"],"published-print":{"date-parts":[[2010,5]]},"DOI":"10.1007\/s11095-010-0080-3","type":"journal-article","created":{"date-parts":[[2010,3,8]],"date-time":"2010-03-08T17:12:04Z","timestamp":1268068324000},"page":"750-755","source":"Crossref","is-referenced-by-count":130,"title":["Metal Impurities in Food and Drugs"],"prefix":"10.1007","volume":"27","author":[{"name":"USP Metal Impurities Advisory Panel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darrell R.","family":"Abernethy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony J.","family":"DeStefano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd L.","family":"Cecil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kahkashan","family":"Zaidi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger L.","family":"Williams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2010,3,9]]},"reference":[{"key":"80_CR1","unstructured":"International Conference on Harmonization. Q3 quality guidelines. 2006. http:\/\/www.ich.org\/cache\/compo\/276-254-1.html (accessed June 22, 2009)."},{"key":"80_CR2","unstructured":"USP. Heavy metals testing methodologies workshop (August 26\u201327, 2008) summary. 2008. www.usp.org\/pdf\/EN\/hottopics\/2008-MetalsWorkshopSummary.pdf (accessed June 22, 2009)."},{"key":"80_CR3","volume-title":"Pharmacopoeia of the United States of America","author":"USP","year":"1820","unstructured":"USP. Pharmacopoeia of the United States of America. Boston: Wells and Lilly; 1820."},{"key":"80_CR4","volume-title":"The pharmacological basis of therapeutics","author":"A Gilman","year":"1941","unstructured":"Gilman A, Goodman L. The pharmacological basis of therapeutics. 1st ed. New York: Macmillan; 1941.","edition":"1"},{"key":"80_CR5","unstructured":"FDA. Orange book: approved drug products with therapeutic equivalence. 2009. www.accessdata.fda.gov\/scripts\/cder\/ob\/default.cfm (accessed June 22, 2009)."},{"key":"80_CR6","unstructured":"EMEA. Guideline on the specification limits for residues of metal catalysts. 2008. www.emea.europa.eu\/pdfs\/human\/swp\/444600enfin.pdf (accessed June 11, 2009)."},{"key":"80_CR7","doi-asserted-by":"crossref","first-page":"1517","DOI":"10.1056\/NEJMoa022848","volume":"348","author":"RL Canfield","year":"2003","unstructured":"Canfield RL, Henderson CR, Cory-Slechta DA, Cox C, Jusko TA, Lanphear BP. Intellectual impairment in children with blood lead concentrations below 10\u00a0\u00b5g per deciliter. N Engl J Med. 2003;348:1517\u201326.","journal-title":"N Engl J Med."},{"key":"80_CR8","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1126\/science.181.4096.230","volume":"181","author":"F Bakir","year":"1973","unstructured":"Bakir F, Damluji SF, Amin-Zaki L, et al. Methyl mercury poisoning in Iraq. Science. 1973;181:230\u201341.","journal-title":"Science."},{"key":"80_CR9","volume-title":"The toxicity of methyl mercury","author":"DO Marsh","year":"1987","unstructured":"Marsh DO. Dose-response relationships in humans: methyl mercury epidemics in Japan and Iraq. In: Eccles CU, Annau Z, editors. The toxicity of methyl mercury. Baltimore: John Hopkins University Press; 1987."},{"key":"80_CR10","volume-title":"Inorganic mercury. Integrated risk information system","author":"EPA","year":"1985","unstructured":"EPA. Inorganic mercury. Integrated risk information system. Washington: EPA; 1985."},{"key":"80_CR11","volume-title":"Cadmium. Integrated risk information system","author":"EPA","year":"1995","unstructured":"EPA. Cadmium. Integrated risk information system. Washington: EPA; 1995."},{"key":"80_CR12","volume-title":"Toxicological profile for lead","author":"ATSDR","year":"2007","unstructured":"ATSDR. Toxicological profile for lead. Atlanta: ATSDR; 2007."},{"key":"80_CR13","doi-asserted-by":"crossref","first-page":"573","DOI":"10.1023\/B:BIOM.0000045741.22924.d8","volume":"17","author":"F Hong","year":"2004","unstructured":"Hong F, Jin T, Zhang A. Risk assessment on renal dysfunction caused by co-exposure to arsenic and cadmium using benchmark dose calculation in a Chinese population. BioMetals. 2004;17:573\u201380.","journal-title":"BioMetals."},{"key":"80_CR14","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1081\/DCT-100100098","volume":"23","author":"EF Madden","year":"2000","unstructured":"Madden EF, Fowler BA. Mechanisms of nephrotoxicity from metal combinations: a review. Drug Chem Toxicol. 2000;23:1\u201312.","journal-title":"Drug Chem Toxicol."},{"key":"80_CR15","doi-asserted-by":"crossref","first-page":"2074","DOI":"10.1038\/sj.ki.5001809","volume":"70","author":"EB Ekong","year":"2006","unstructured":"Ekong EB, Jaar BG, Weaver VM. Lead-related nephrotoxicity: a review of the epidemiologic evidence. Kidney Int. 2006;70:2074\u201384.","journal-title":"Kidney Int."},{"issue":"11","key":"80_CR16","doi-asserted-by":"crossref","first-page":"1627","DOI":"10.1289\/ehp.8033","volume":"113","author":"A \u00c5kesson","year":"2005","unstructured":"\u00c5kesson A, Lundh T, Vahter M, et al. Tubular and glomerular kidney effects in Swedish women with low environmental cadmium exposure. Environ Health Perspect. 2005;113(11):1627\u201331.","journal-title":"Environ Health Perspect."},{"key":"80_CR17","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1016\/0140-6736(90)92201-R","volume":"336","author":"JP Buchet","year":"1990","unstructured":"Buchet JP, Lauwerys R, Roels H, et al. Renal effects of cadmium body burden of the general population. Lancet. 1990;336:699\u2013702.","journal-title":"Lancet."},{"issue":"23","key":"80_CR18","doi-asserted-by":"crossref","first-page":"2868","DOI":"10.1001\/jama.292.23.2868","volume":"292","author":"RB Saper","year":"2004","unstructured":"Saper RB, Kales SN, Paquin J, et al. Heavy metal content of ayurvedic herbal medicine products. JAMA. 2004;292(23):2868\u201373.","journal-title":"JAMA."},{"key":"80_CR19","doi-asserted-by":"crossref","first-page":"2405","DOI":"10.1080\/00032710701577500","volume":"40","author":"S Honary","year":"2007","unstructured":"Honary S, Ebrahimi P, Naghibi F, Mosaddegh M, Shahhoseini S. Study on the simultaneous determination of Pb and Cd in some commercial medicinal plants by both atomic absorption and voltametry methods. Anal Lett. 2007;40:2405\u201314.","journal-title":"Anal Lett."},{"key":"80_CR20","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1016\/j.fct.2003.11.004","volume":"42","author":"ED Caldas","year":"2004","unstructured":"Caldas ED, Machado LL. Cadmium, mercury, and lead in medicinal herbs in Brazil. Food Chem Toxicol. 2004;42:599\u2013603.","journal-title":"Food Chem. Toxicol."},{"key":"80_CR21","doi-asserted-by":"crossref","first-page":"1263","DOI":"10.1016\/j.fct.2007.01.007","volume":"45","author":"M Rose","year":"2007","unstructured":"Rose M, Lewis J, Langford N, et al. Arsenic in seaweed\u2014forms, concentration, and dietary exposure. Food Chem Toxicol. 2007;45:1263\u20137.","journal-title":"Food Chem Toxicol."},{"issue":"2","key":"80_CR22","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1016\/j.yrtph.2007.03.001","volume":"48","author":"JF Kauffman","year":"2007","unstructured":"Kauffman JF, Westenberger BJ, Robertson JD, Guthrie J, Jacobs A, Cummins SK. Lead in pharmaceutical products and dietary supplements. Regul Toxicol Pharmacol. 2007;48(2):128\u201334.","journal-title":"Regul Toxicol Pharmacol."},{"key":"80_CR23","unstructured":"Turck M. Metals in active pharmaceutical ingredients and excipients. Presentation to Institute of Medicine of the National Academy of Sciences of the United States, Washington, DC, USP Heavy Metals Testing Methodologies Workshop, August 26, 2008."},{"key":"80_CR24","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1080\/15287390500196230","volume":"9","author":"RA Yokel","year":"2006","unstructured":"Yokel RA, Lasley SM, Dorman DC. The speciation of metals in mammals influences their toxicokinetics and toxicodynamics and therefore human health risk assessment. (Critical Review) J Toxicol Environ Health B. 2006;9:63\u201385.","journal-title":"(Critical Review) J Toxicol Environ Health B"},{"key":"80_CR25","doi-asserted-by":"crossref","first-page":"743","DOI":"10.1016\/j.envint.2009.01.005","volume":"35","author":"VK Sharma","year":"2009","unstructured":"Sharma VK, Sohn M. Aquatic arsenic: toxicity, speciation, transformations, and remediation. Environ Int. 2009;35:743\u201359.","journal-title":"Environ Int."},{"key":"80_CR26","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1007\/978-1-4612-2656-7_3","volume":"136","author":"ME Losi","year":"1994","unstructured":"Losi ME, Amrhein C, Frankenberger WT. Environmental biochemistry of chromium. Rev Environ Contam Toxicol. 1994;136:91\u2013121.","journal-title":"Rev Environ Contam Toxicol."},{"key":"80_CR27","first-page":"97","volume":"184","author":"KF Akter","year":"1005","unstructured":"Akter KF, Owens G, Davey DE, Naidu R. Arsenic speciation and toxicity in biological systems. Rev Environ Contam Toxicol. 1005;184:97\u2013149.","journal-title":"Rev Environ Contam Toxicol."},{"key":"80_CR28","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1289\/ehp.00108309","volume":"108","author":"GM Scelfo","year":"2000","unstructured":"Scelfo GM, Flegal AR. Lead in calcium supplements. Environ Health Perspect. 2000;108:309\u201319.","journal-title":"Environ Health Perspect."},{"issue":"2","key":"80_CR29","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1016\/j.yrtph.2007.03.001","volume":"48","author":"JF Kauffman","year":"2007","unstructured":"Kauffman JF, Westenberger BJ, Robertson JD, Guthrie J, Jacobs A, Cummins SK. Lead in pharmaceutical products and dietary supplements. Regul Toxicol Pharmacol. 2007;48(2):128\u201334.","journal-title":"Regul Toxicol Pharmacol."},{"issue":"16","key":"80_CR30","doi-asserted-by":"crossref","first-page":"6892","DOI":"10.1021\/jf801236w","volume":"56","author":"WR Mindak","year":"2008","unstructured":"Mindak WR, Cheng J, Canas BJ, Bolger PM. Lead in women\u2019s and children\u2019s vitamins. J Agric Food Chem. 2008;56(16):6892\u20136.","journal-title":"J Agric Food Chem."},{"key":"80_CR31","unstructured":"Waxman HA. Letter to FDA regarding Vitamin Shoppe Multivitamins Especially for Women. April 4, 2007. http:\/\/oversight.house.gov\/documents\/20070409120002.pdf (accessed September 15, 2009)."},{"issue":"5","key":"80_CR32","doi-asserted-by":"crossref","first-page":"1307","DOI":"10.1021\/jf026055x","volume":"51","author":"SP Dolan","year":"2003","unstructured":"Dolan SP, Nortrup DA, Bolger PM, Capar SG. Analysis of dietary supplements for arsenic, cadmium, mercury, and lead using inductively coupled plasma\u2013mass spectrometry. J Agric Food Chem. 2003;51(5):1307\u201312.","journal-title":"J Agric Food Chem."},{"issue":"13","key":"80_CR33","doi-asserted-by":"crossref","first-page":"3738","DOI":"10.1021\/jf0115591","volume":"50","author":"AA Carbonell-Barrachina","year":"2002","unstructured":"Carbonell-Barrachina AA, Garc\u00eda E, S\u00e1nchez Soriano J, Aracil P, Burl\u00f3 F. Effects of raw materials, ingredients, and production lines on arsenic and copper concentrations in confectionery products. J Agric Food Chem. 2002;50(13):3738\u201342.","journal-title":"J Agric Food Chem."},{"issue":"26","key":"80_CR34","doi-asserted-by":"crossref","first-page":"7822","DOI":"10.1021\/jf049150+","volume":"52","author":"P Raman","year":"2004","unstructured":"Raman P, Patino LC, Nair MG. Evaluation of metal and microbial contamination in botanical supplements. J Agric Food Chem. 2004;52(26):7822\u20137.","journal-title":"J Agric Food Chem."},{"key":"80_CR35","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1016\/S0009-8981(00)00205-9","volume":"296","author":"G Komaromy-Hiller","year":"2000","unstructured":"Komaromy-Hiller G, Ash KO, Costa R, Howerton K. Comparison of representative ranges based on US patient population and literature reference intervals for urinary trace elements. Clin Chim Acta. 2000;296:71\u201390.","journal-title":"Clin Chim Acta."},{"key":"80_CR36","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1006\/enrs.1997.3793","volume":"76","author":"DC Paschal","year":"1998","unstructured":"Paschal DC, Ting BG, Morrow JC, et al. Trace metals in urine of United States residents: reference range concentrations. Environ Res. 1998;76:53\u20139.","journal-title":"Environ Res."},{"key":"80_CR37","unstructured":"IARC. Arsenic in drinking-water. 2004. http:\/\/monographs.iarc.fr\/ENG\/Monographs\/vol84\/mono84-6A.pdf (accessed July 16, 2009)."},{"key":"80_CR38","unstructured":"EPA. Integrated risk information system (IRIS) on arsenic. 1999. http:\/\/www.epa.gov\/iris\/subst\/0278.htm (accessed December 02, 2009)."},{"key":"80_CR39","volume-title":"Toxicological profile for cadmium (Draft for Public Comment)","author":"ATSDR","year":"2008","unstructured":"ATSDR. Toxicological profile for cadmium (Draft for Public Comment). Atlanta: ATSDR; 2008."},{"key":"80_CR40","unstructured":"USP. Pharmacopoeia of the United States of America, Procedure 121, Time-limit test for heavy metals. 8th Revision. Philadelphia: Lippincott; 1905."},{"key":"80_CR41","unstructured":"USP. Pharmacopoeia of the United States of America, Heavy metals test. 12th Revision. Easton, PA: Mack Printing; 1942."},{"key":"80_CR42","unstructured":"USP. USP 32\u2013NF 27, Heavy Metals <231>. Rockville, MD: USP; 2009."},{"key":"80_CR43","volume-title":"European pharmacopoeia, Chapter 2.4.8, Heavy metals","author":"European Directorate for the Quality of Medicines and HealthCare","year":"2009","unstructured":"European Directorate for the Quality of Medicines and HealthCare. European pharmacopoeia, Chapter 2.4.8, Heavy metals. 6th ed. Strasbourg: EMEA; 2009.","edition":"6"},{"key":"80_CR44","volume-title":"Japanese pharmacopoeia, Chapter 1.07, Heavy metals limit test","author":"Ministry of Health, Labour, and Welfare","year":"2001","unstructured":"Ministry of Health, Labour, and Welfare. Japanese pharmacopoeia, Chapter 1.07, Heavy metals limit test. 15th ed. Tokyo: MHLW; 2001.","edition":"15"},{"key":"80_CR45","volume-title":"International pharmacopoeia, Chapter 2.2.3, Limit test for heavy metals","author":"WHO","year":"2006","unstructured":"WHO. International pharmacopoeia, Chapter 2.2.3, Limit test for heavy metals. 4th ed. Geneva: WHO; 2006.","edition":"4"},{"key":"80_CR46","first-page":"1632","volume":"21","author":"KB Blake","year":"1995","unstructured":"Blake KB. Harmonization of the USP, EP, and JP heavy metals testing procedures. Pharm Forum. 1995;21:1632\u20137.","journal-title":"Pharm Forum."},{"key":"80_CR47","doi-asserted-by":"crossref","first-page":"739","DOI":"10.1016\/j.jpba.2004.02.023","volume":"35","author":"N Lewen","year":"2004","unstructured":"Lewen N, Mathew S, Schenkenberger M, Raglione T. A rapid ICP\u2013MS screen for heavy metals in pharmaceutical compounds. J Pharm Biomed Anal. 2004;35:739\u201352. PMID: 15193718.","journal-title":"J Pharm Biomed Anal"},{"key":"80_CR48","doi-asserted-by":"crossref","first-page":"867","DOI":"10.1016\/S0731-7085(00)00361-7","volume":"23","author":"T Wang","year":"2000","unstructured":"Wang T, Wu J, Hartman R, Jia X, Egan RS. A multi-element ICP\u2013MS survey method as an alternative to the heavy metals limit test for pharmaceutical materials. J Pharm Biomed Anal. 2000;23:867\u201390.","journal-title":"J Pharm Biomed Anal."}],"container-title":["Pharmaceutical Research"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s11095-010-0080-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s11095-010-0080-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s11095-010-0080-3","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,6,1]],"date-time":"2019-06-01T05:43:18Z","timestamp":1559367798000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s11095-010-0080-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,3,9]]},"references-count":48,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2010,5]]}},"alternative-id":["80"],"URL":"https:\/\/doi.org\/10.1007\/s11095-010-0080-3","relation":{},"ISSN":["0724-8741","1573-904X"],"issn-type":[{"value":"0724-8741","type":"print"},{"value":"1573-904X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,3,9]]}}}