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[{"key": "dc.contributor.advisor", "value": "V\u00e4is\u00e4nen, Ari", "language": "", "element": "contributor", "qualifier": "advisor", "schema": "dc"}, {"key": "dc.contributor.advisor", "value": "Kivilahti, Antti", "language": "", "element": "contributor", "qualifier": "advisor", "schema": "dc"}, {"key": "dc.contributor.author", "value": "Pakkanen, Sampo", "language": "", "element": "contributor", "qualifier": "author", "schema": "dc"}, {"key": "dc.date.accessioned", "value": "2018-06-21T07:47:41Z", "language": null, "element": "date", "qualifier": "accessioned", "schema": "dc"}, {"key": "dc.date.available", "value": "2018-06-21T07:47:41Z", "language": null, "element": "date", "qualifier": "available", "schema": "dc"}, {"key": "dc.date.issued", "value": "2018", "language": "", "element": "date", "qualifier": "issued", "schema": "dc"}, {"key": "dc.identifier.uri", "value": "https://jyx.jyu.fi/handle/123456789/58700", "language": null, "element": "identifier", "qualifier": "uri", "schema": "dc"}, {"key": "dc.description.abstract", "value": "T\u00e4ss\u00e4 Pro Gradun kokeellisessa osassa kehitettiin kattava analyysimenetelm\u00e4 alkuaine-ep\u00e4puhtauksien analysoimiseen l\u00e4\u00e4kevalmisteista ICP-OES -laitteella, ja l\u00e4\u00e4keaineanalyysit tehtiin Fermion Oulun laboratoriossa. Kehitetty analyysimenetelm\u00e4 t\u00e4ytti ICH Q3D ohjeistuksen, Amerikan Yhdysvaltojen farmakopean ja l\u00e4\u00e4keaineiden hyv\u00e4n toimintatavan (GMP) vaatimukset. Yhteens\u00e4 92 eri l\u00e4\u00e4kevalmistetta analysoitiin. Cd, Pb, As, Hg, Co, V, Ni, Tl ja Pd pitoisuudet l\u00e4\u00e4kevalmisteissa kvantitoitiin k\u00e4ytt\u00e4en ulkoista kalibrointia, jossa oli yhteensopiva n\u00e4ytematriisi, ja Au, Ir, Rh, Ru, Se, Ag, Pt, Li, Sb, Ba, Mo, Cu, Sn ja Cr m\u00e4\u00e4ritettiin rajakokeella. Menetelm\u00e4n varmennus tehtiin k\u00e4ytt\u00e4en standardilis\u00e4ysn\u00e4ytteit\u00e4, kalibroinnin oikeellisuutta seurattiin QC-n\u00e4ytteill\u00e4 ja menetelm\u00e4lle laskettiin m\u00e4\u00e4ritysrajat kullekin alkuaineelle. Lopuksi l\u00e4\u00e4kevalmisteen k\u00e4ytt\u00e4j\u00e4n p\u00e4ivitt\u00e4iset altistusm\u00e4\u00e4r\u00e4t kullekin ep\u00e4puhtaudelle laskettiin, ja n\u00e4it\u00e4 tuloksia verrattiin sallittuihin p\u00e4ivitt\u00e4isiin altistusrajoihin.\n\nMenetelm\u00e4 oli riitt\u00e4v\u00e4n tarkka, robusti, selektiivinen ja luotettava t\u00e4ytt\u00e4m\u00e4\u00e4n l\u00e4\u00e4kealan ohjeistukset alkuaine-ep\u00e4puhtauksien m\u00e4\u00e4ritt\u00e4misess\u00e4. Kokeellisen osan tulokset osoittavat, ett\u00e4 alkuaine-ep\u00e4puhtauksien m\u00e4\u00e4r\u00e4 kaikissa l\u00e4\u00e4kevalmisteissa aiheuttaa pienemm\u00e4n altistuksen, kuin sallitut p\u00e4ivitt\u00e4iset altistukset kullakin ep\u00e4puhtaudella. Alkuaine-ep\u00e4puhtauksista kaikista eniten huomiota tuli kiinnitt\u00e4\u00e4 lyijyyn, sill\u00e4 sen pitoisuudet olivat useassa l\u00e4\u00e4kevalmisteen n\u00e4ytematriisissa yli m\u00e4\u00e4ritysrajan, ja lyijyn sallitut pitoisuudet olivat alhaisimmat kaikista m\u00e4\u00e4ritett\u00e4vist\u00e4 alkuaineista. Muita kehitt\u00e4miskohteita havaittiin n\u00e4ytteenhajotuksessa, jossa oli v\u00e4lill\u00e4 haasteita, sek\u00e4 palladiumin m\u00e4\u00e4rityksen luotettavuudessa, sill\u00e4 sen standardinlis\u00e4ysn\u00e4ytteiden saannot olivat vaihtelevan alhaisia eri n\u00e4ytteill\u00e4.\n\nT\u00e4m\u00e4n tutkielman kirjallisessa osassa k\u00e4sitell\u00e4\u00e4n ICH Q3D ohjeistuksen ja Amerikan Yhdysvaltojen farmakopean alkuaine-ep\u00e4puhtauksista kertovia osioita, miten n\u00e4it\u00e4 ohjeistuksia sovelletaan k\u00e4t\u00e4nn\u00f6ss\u00e4 eri laadunvalvontalaboratorioissa, sek\u00e4 miten siirtyminen vanhoista analyysimenetelmist\u00e4 uusiin on tapahtunut eri tieteellisten artikkelien perusteella. Kirjallisessa osassa k\u00e4sitell\u00e4\u00e4n my\u00f6s ICP-OES tekniikkaa yleisesti ja l\u00e4\u00e4keteollisuuden alkuaineanalytiikassa, ja miten menetelm\u00e4n varmennusta ja validointia tehd\u00e4\u00e4n l\u00e4\u00e4keteollisuuden ja GMP:n mukaisesti.", "language": "fi", "element": "description", "qualifier": "abstract", "schema": "dc"}, {"key": "dc.description.abstract", "value": "An extensive method for analysing elemental impurities with ICP-OES in pharmaceutical products was developed and conducted in Fermion Oulu laboratory in the experimental part of this thesis. The method was developed to fulfill requirements of ICH Q3D Guideline on elemental impurities, US Pharmacopoeia and current good manufacturing practises in pharmaceutical industry. A total amount of 92 different products were analysed. Cd, Pb, As, Hg, Co, V, Ni, Tl and Pd were quantified from samples using matrix matched external calibration and a limit test for Au, Ir, Rh, Ru, Se, Ag, Pt, Li, Sb, Ba, Mo, Cu, Sn and Cr were conducted. Method verification was done with spike samples, continuous calibration verification and quality control samples and calculating method quantification limits. Daily exposures of each element were finally calculated from the concentration and limit test data and compared to the permitted daily exposures. \n\nThe method showed sufficient accuracy and reliability to the pharmaceutical guideline requirements. The results showed that elemental impurity levels were low throughout all sample matrices, and impurity levels were not over the permitted daily exposures in any of the pharmaceutical products analysed. Of all the elemental impurities, lead had to be taken most into consideration in this project, because low concentrations of lead over quantification limit was found in several products, and lead had the lowest PDEs of all impurities. Some challenges were encountered in the sample digestion, and the method was found to be unreliable in analysing palladium in several sample matrices, yielding low spike recoveries.\n\nThe theoretical part covers the ICH Q3D guideline and the new US Pharmacopoeia chapters about elemental impurities, and how they are applied in quality control laboratories, and how the transition from the old heavy metal tests to the new ones been done in pharmaceutical industry according to scientific articles. Also ICP-OES technique in pharmaceutical analytics is discussed and how method verification and validation are done with ICP-OES technique accorfing to GMP and pharmaceutical industry guidelines.", "language": "en", "element": "description", "qualifier": "abstract", "schema": "dc"}, {"key": "dc.description.provenance", "value": "Submitted by Riitta Pitk\u00e4nen (rpitkane@jyu.fi) on 2018-06-21T07:47:41Z\nNo. of bitstreams: 0", "language": "en", "element": "description", "qualifier": "provenance", "schema": "dc"}, {"key": "dc.description.provenance", "value": "Made available in DSpace on 2018-06-21T07:47:41Z (GMT). No. of bitstreams: 0\n Previous issue date: 2018", "language": "en", "element": "description", "qualifier": "provenance", "schema": "dc"}, {"key": "dc.format.extent", "value": "87", "language": "", "element": "format", "qualifier": "extent", "schema": "dc"}, {"key": "dc.format.mimetype", "value": "application/pdf", "language": null, "element": "format", "qualifier": "mimetype", "schema": "dc"}, {"key": "dc.language.iso", "value": "eng", "language": null, "element": "language", "qualifier": "iso", "schema": "dc"}, {"key": "dc.rights", "value": "In Copyright", "language": "en", "element": "rights", "qualifier": null, "schema": "dc"}, {"key": "dc.subject.other", "value": "ICP-OES", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "ICP-AES", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "pharmaceutical", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "heavy metals", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "GMP", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "validation", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "digestion", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "ICH", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "Q3D", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "trace analysis", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.subject.other", "value": "quality control", "language": "", "element": "subject", "qualifier": "other", "schema": "dc"}, {"key": "dc.title", "value": "Determination of Elemental Impurities in Pharmaceutical Products using Inductively Coupled Plasma Emission Spectrometry", "language": "", "element": "title", "qualifier": null, "schema": "dc"}, {"key": "dc.type", "value": "master thesis", "language": null, "element": "type", "qualifier": null, "schema": "dc"}, {"key": "dc.identifier.urn", "value": "URN:NBN:fi:jyu-201806213320", "language": "", "element": "identifier", "qualifier": "urn", "schema": "dc"}, {"key": "dc.type.ontasot", "value": "Pro gradu -tutkielma", "language": "fi", "element": "type", "qualifier": "ontasot", "schema": "dc"}, {"key": "dc.type.ontasot", "value": "Master\u2019s thesis", "language": "en", "element": "type", "qualifier": "ontasot", "schema": "dc"}, {"key": "dc.contributor.faculty", "value": "Matemaattis-luonnontieteellinen tiedekunta", "language": "fi", "element": "contributor", "qualifier": "faculty", "schema": "dc"}, {"key": "dc.contributor.faculty", "value": "Faculty of Sciences", "language": "en", "element": "contributor", "qualifier": "faculty", "schema": "dc"}, {"key": "dc.contributor.department", "value": "Kemian laitos", "language": "fi", "element": "contributor", "qualifier": "department", "schema": "dc"}, {"key": "dc.contributor.department", "value": "Department of Chemistry", "language": "en", "element": "contributor", "qualifier": "department", "schema": "dc"}, {"key": "dc.contributor.organization", "value": "Jyv\u00e4skyl\u00e4n yliopisto", "language": "fi", "element": "contributor", "qualifier": "organization", "schema": "dc"}, {"key": "dc.contributor.organization", "value": "University of Jyv\u00e4skyl\u00e4", "language": "en", "element": "contributor", "qualifier": "organization", "schema": "dc"}, {"key": "dc.subject.discipline", "value": "Ep\u00e4orgaaninen ja analyyttinen kemia", "language": "fi", "element": "subject", "qualifier": "discipline", "schema": "dc"}, {"key": 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