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BIOMALYTICALREpORT
Tite: Das: Authors:
PreparedFor.
AvoaTipmtNo:
QPuaetictitveuDecterrm(ioAnaFtoFiOonc)o,tMfeAasmszeoecdratsethee SPtudey DcWOuUsoogTArnwiboono(lPooFOAScp)r,aiytnLHOaumManSn MSeoSrusmfreom 30Septemb20e0r3 DSavuidJsALnadMerusrnopnh,ayM,SB.hS. TeL.Roamacs y,MPeS. 1Ad5vCioanhBriwooScoideRnoceasd, a. Ithaca, NewYork 14850 EDnuvPioroontmHeanstkaelllSLciacocbe orfoarHteaoltraynd
+ 2100.30Boxio0nRNoeawda.rk,DE 1971JMR
GZIADIADUDOC
`Advion Intecaal
Study ID:
DWo4.
Number ofPages: 1
Tem
"pTehceiocronoooscatraantoisotnsoafmaomenm(oPnFiOoAm)p, aescdetlezmuinre oi(bAoPuFncOa)ts,meemraesosuarnmdpaltetsshceollec duervielnogptehdeSbtyuAddyviDoWnOBSisiSngcseiloncccti.ov,saeecacs,rNe,Y,.odreproducible anlyialmethod
10HiusnoalantseePrFumOsAaamnpdlehse(0i.n0te2r5nmaEls)twdearde(xOtFracbteedxbaydecliaqiuiudo-lrioquniedemxatrnaaocciticdo,n procedire lSiHquLiEdDcFNAh).Frolloowinmg reaconmstattsusioosnp,egcstarmormpelteraeyxt(rLapcOtsMwSheIrMeySs)aiahnlytzheeadnbegynatirvhdeoioonenmsodpnea.y
A2l8l0s.a0m5plegswfe.rfsourcPcFeOsfAu.lTlyheaplryecziesdiwointohfitnoiseassoaay.T(hCVe)laoswdeertleirmtinoefdfqruaonmtitthaetion alysisof quality contol (QC) samplesforPFOA:was 4.11%.
`CompanySahitized.Doesnot containTSCACBI
600134
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SIGNATURE PAGE
Tite:
Q(uAaPnFtOit)a,tMiveeasDureedtaszthmePeioffinAomraamootcntiiazuonmstPeeAfnuioornoo(cPtFzaOoAs)tiea
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Advion Report No.: 02331ADIA_DUJ
Reportedby:
AW lL DMavaid.nofaBiogwaieAyiSs
3pseD 2003 Date
Authorized for
Releaseby:
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QaU STATEMENT
eT tmcpte----T QualityAssurance UnitofAdvionBioSciences(Advion).
[Spletogobinder [DemBeiew
Tilman? TS Decombur2002
[simmons
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31 December20z
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S E n R --
{pits Quality AssuranceAaditor
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QA STATEMENT cccmmrerererrssmmsmsssssmmmmmsmesssmemsomersmnd `TOA FCOBNTELNTSE creesenmssmssssmssmssrmmmmsmssssmamendh LIST OFTABS ccmmmmmrrremmssmsmmsrmsmmmmmmessmosommismammnsaonS LIST OF FIGURES commensal
1.1. StudyDESCE20diOBpJ6CoHVnE crores sommes
2.1. Analytical PROCEUHS) erences 22. AS SIEe R gress --------
32. AnaRleSuyltstorSiOcYDaWOlS c.ecomemremmennnd 4 DATARETRIEVAL ccersorsmsmmesmmrmmssssmssmssssmssmsmsmesrmned
LI
AJ
7. FIGURES cosossrssmrt smsmsssmmsmssssnes ws ssserseens 16.
.
Pagers
@s31ADIADUDOC 000137
ustorTamas
Table 1: SummofaSermpylemdAssay Iaformaion for StudyDWOS cv 10 Table2: PrL essionandAccuracyforPFOAQualitA yControlSamplesin Hum Seu Tie: PE dronsndArcam fePOAClfA rlon Sunde omen Snr `Table 4;Ca0li8bSr0a2t8ioDnCWuOrRv.eStc atistice s forthseDsetmersmirnatmiomnoefsPsFOsAisnmHuemamnnSerum 13 Table S: ConcenotfrPFaOAtiinHounmasn Secu Samples romStudy DWOA......14
Pages
asnaDiapuDOC
000138
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LIST OF FIGURES
Figure 1:S`eStiacntdeadrRdeiancCtoinotnroMloBnlitaokriBngaClniomSteogeEaXmUsGoEfPFvrOAoanrdheeIntrernael 16 Figure2:S`eSlteacntdeadrdfReraocmtioHn uMamraitnoSreiraugmChErxotmraatoCgornatmasinoifnPgFlaOtAeresnaldStthaendIanredOaslly
Figure 3: S`eStlacntdeadrRdearcotmionSMtoannidatrodri|nHguChmraonmSaetrogurmaEmxstorafctPF(O0A.05eBndLthe)Intcuavlee 18 Figure 4:S`eSltoatndeadrRdearcotmioanSMtoannidatrodri9nHgCuharonmSateoguramEsXoTfAPEF(1O0ABanLd)therntoemael 19
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Pcsocis
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000139
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+ mmopvertan
11. StudyDescrisnpd Otbjiecotinve
p`eTrhfelaoobrjoecotcitvaenoofatthei(ssAtPuFdOy)w,maseatsoduerteeramsitnehtpheercfleuncerconoactiaonnosioesfeaiomnm(oPnFiOuAm), ihuman. s`eBirouSmcsiaenmcpelsesncco.l(lAedctveidodnu)rfioognSttudly DtWraOck4i.nTg hpeusrtpuodsyeI. DH was guseernum mesarbma apylAtedsven iwoednre atnaanldyezmemdasssisnpgecstelreocmteivteryi(gLiOd-MiSq/uMiSd )exatrsaacyti.oTn,htebwoorkodn speraycliiqnuritdhciihsrboibmoamtmoaeglyrtadcpahly! reportwasconductedin ccordancewith Advionstandardoperatingprocedures (SOP). 2 METHODS | 21. Analytical Procedures)
L"CP/FOMASc/onMcSeamtertathioodus(w1)e.rSeedreumeasiamnpeldeisn(h0.u0m2a5mnLse)rwuemarceceoxrtdriancgefdobtyhevlailgiidda-tleidquid Feoxltlraocwtiionngprrecoocnesdtiutruetiooni,ssolaamtpetlheeextraalctyswaenrdeinsteepraaraaltesdtbanydreve(r1s5e)fdr-pohmase mansen. Bcehlrloemfaotnotger,aPpAh)ywointhaa2.ni50t1ammmo(5ljeap)hBaesteaosf 4C5y%cElouleaat (BT(h9e0c:m1o0Fmyeptehransoilk:Keystone, 928mhMeaxsaodmeocnaifulmuaocreoanota)aaunacdi3dc5(% ElSnaFA (-1w0a:5sE0wmeetdDhaansoFlth:eI2NSmfMorAamPmF)oOnAi.uPmFacOeAtate). csopneccetnrtormaettiroyn(sweLredCele/iinnMetdhbeSnyetgab/toivMefoinosSnpmroad)ye.quidchromatographyademmass Fsoalmlpolewsi)n,gstbuadcyksgaromupnldesucbotnrcaectpitoin(oonrswcearliebdratteiconnsitnaenddfarodsm,QaCwseaimgphlteeds,(1n/cd)2,q0uadratic r`eBgormeisnsailocnoofpenakcareeorfantniionste(cpaerlaibararteitsonosiftPanFodOa/rndpse.Takhaerenaoomifna9l5-cHoDnFcNbAn)tveartsiuosfotnhse calibration standardswere 0.05,01,025,0.5,1,2,5,7.5 0d 10gal,PFOA. c"oTnhterloqlw(eQsCi)nsiutuofmqsuaanmtpiltaetsiaotn(tLhLreAeQd)iffoertciatscaosnscayewpatsi0o.n0s5(0g./15m,L3,PmFdOA8. gQufal,ity PFOA)wereanalyzedinreplicate of three. cTahliebarcactieopntsatnacnedcairtdesimaufsotcraelciwbriaatoiotnhsteacnaldiabrrattsitoinpcuulravteetfhoraeaatchfemaatltihrceae-lforuur.thsofthe Calibration standardsmaybe rectedif theyshow deviations>15% fomtheirnominal
`concentration(20%attheLLQ):The coofficientofdetermination ()mustbe20.98.
iTnhdievaicdcueapltQanCcsecarmiptleersiamfuorstthebequwailtihtiynco1nt5r%olosfatmhpelneosmstiinpaullactoendc(eanttrattwioo-nt,whiddsaotfltehaest
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Concentration.
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TspumlmaarsyowfetheeprsecpsaprleedmadtAadsvsiaoyninifoamdavtaisocneofforhSeacdolyleDcYtWioOn4oifssgeirvuemnsTeabples1.is "TShteyp,urTphoseetiofptblhanikpswbelarnkpsrweapasreadbyrseicdaisnogcnoanrtyrmoelahnusma0nsmoreittrocoraplotlenitnialbes. contoaf stmudysiamnpleasdatriogishiopmennt.
22 Assaysie Alsampleswereanalyzed a AdvionBioSeicacs, oc, aca,NY.
23. DaaProcessing
I aTrocdsawtearweeirlegglaelcetdebdy tshienAgptplbisdfoBiosSpyrsatyeLmOspIrMoSg/rMaSmMiatchCeQunaenga,tvievresiioonnm1o6d,ee.siPdeinsg
o`nMacMQcuianntwoesrhscaovmepdutaert.eFxotllleosw,iwnhgipcehawkeareausnelgtroapieocnf,otrhabFaocukglrsoaubnldessufbtoramction,
A`vBaickgroSulnd:ssivbetrawchteerddeaatawweeirgehseadv(e1d11)sqMuaacdQruatainctreexgrtefsisleisoanvnidsuppleorafdorme(d0utshieng the
softwarepackage Watson (v 6.1.0.03, InnaPhaseCorp.,Philadelphia,PA). Concentration
`ddoawtanwleoraeddeodwfnolroaaWdaetdsfornowmitWhattrsoenswdietchimtharlelesaicgenisfaicdanrtofuingduereds.1S0ttatrisetiscisgwiefriec.ant pres priororeporting.
3 RESULTS
31. AssayPerformance
dTohceapmeernftomeadnncTeaobflteh2e.aTshseyinftorraP-aFsOsAayspsredceitseiromni(nCeVd)foofmQCth saalmpylseissroafnQgeCdfsraommpl3e.s14is 10.4.11% oxPFOA.Therewasnomnked nscuracyinth resulsfomtheseQC
`samples;meanaccuracy(RE)rangedfrom -10.7 10 -6.33%.
`Tmhaerpkeecdtionrsmcaenacreacoyifndtahleyrceaallfrsafioonmtcuhrevseessitsadndoacrudmse;mseiadnfsoTcaubelaecy3.rTahnegeesdwraos52060 500%.
rectors
amopusoc
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preseacTatbleed4. The valuewas0.9958for PFOAinhumanserum.
ADAedditiobyceosenrd5sshirgesedsodtslhyediphlse fco eicesgrR eti woefel iBdsoy onwr
Festsinsle y ros A:
Fe4e5pessrootdmpFesete,3fRoarprPtOaeiAvceocneomokposd So0sn PpFlOAwsasnpriesse|d
32. Anal Resuy ltst fori Stucdya DWl 04
TPFohOneAeocioyancekmsneimaimaonne1rrnioAmmoSotytsEDVOI3O8040b3reo4prr3e0tg1e0di TaTee.A.L
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CommonRong) HonSam vy uno SyrayLERGSIS. MeasuredasthePerflnoAr nioon(oPFcOAt,0a.05ntoo10apgt/emL
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6 TaBLES TbIeL: SummaryofSpl nd Asay nformatin forSeyDRA
SampleCollectionaad Storage formations
ADanSltooemngReeacTegielvemdSpaeAebdrvesatirtA:duvirone: Number ofStudySeplesRoaived:
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NumbecofStudySuplesAmayect. 65
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O31ADIA_DUDOC
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000151