ASTM_D_5250_-_06_2015_rus_scan.pdf

EAEPANbHOE ArEHTCTBOnO TEXHNYECKOMy PErynMPOBAHMKO N METPONOrWNHAUMOHANbHbINOCTPCTAHAAPTPOCCNNC KON57403-EDEPA4MM2017nEPYATKN MENUNHCKNEN3 nonNBNHNnXnOPNATexHnyeckne Tpe6oBaHnAM3 qaHne o中MunanbHoeMocKBaCTaHnapTMHopM2017FOCT P 57403-2017CoAepxaHne1 06nacTb npMeHeH.12 HopMaTBHble ccbInK.3 MaTepanbl.24 Ha3HaeHne u npuMeHeHe.25 OT6op o6pa3LOB.26 Tpe6oBaHnA.27 MeToAbi cnbITaH.38 peMka.49 ynakoBka n MapknpoBka ynaKoBKM.门punoxeHne AA(cnpaBo4Hoe)CBeAeHnA o cooTBeTcTBnn ccbino4HbIX cTaHgapToB HaLOHanbHbIM MexrocyAapcTBeHHbIM cTaHAapTaM.6f0CTP57403-2017U.S.Pharmacopeia(apMakones CLA)3)3 MaTepnanbl3.1 n n3roToBneHna nepuaTok ncnonb3yIOT No6yto pe3MHoBylo CMeCb Ha OCHoBe nonnBWHnnxnop-Aa,o6ecneynBalouyo CooTBeTCTBNe Tpe6oBaHMAM HacToawero cTaHnapTa.3.2 Ha nepyaTkn MOXKHO HaHOCNTb CMa304HbIn MaTepnan,COoTBeTCTBylownn Tpe6oBaHNAM apMaKo-nen CLA,Ana a6cop6upyemoro onyapuBalowero BewecTBa.AonyckaeTca ncnonb3oBaTb Apyrne CMa304HbleMaTepnanbl,ecnn npenBapnTenbHo 6blnn ycTaHoBneHbl nx 6e3onacHOCTb w 3obeKTNBHOCTb.3.3 Ha BHyTpeHHIOIO HapyKHylo noBepxHOCTn ANarHocTwuecKnx nepuaTok N3 nonnBNHnnxnopnaaTanbK He HaHOCAT.4 Ha3HayeHne n npnMeHeHne4.1 Tpe6oBaHna HacToawero cTaHAapTa wcnonb3yIoT npn oueHke KayecTBa w 6e3onacHocTW AMarHoc-TN4ecKMx nepuaTok N3 nonBNHNnxnopnna.B HacToaweM CTaHnapTe He ycTaHoBneHbl Tpe6oBaHna no 6e30-nacHoMy M npaBnnbHoMy wcnonb3oBaHnlo nNarHOCTNyecknx nepyaTok N3 nonMBNHNnxnopwna.5 OT6op o6pa3uoB5.1 Ana onpeneneHna CooTBeTCTBNa Tpe6oBaHNAM pa3nena 6 06pa3ubl nepuaToK oT6upaoT n3 roTOBbIXM3gennn nocne cTepnnn3aunn n npoBepaoT B COoTBeTCTBMM C VCO 2859.YpoBHN KOHTpona n npeaen npweM-neMoro KayecTBa AQL AOnKHbl COoTBeTCTBOBaTb yKa3aHHblM B Ta6nnue 1 wnn AonKHbl 6bITb cornacoBaHblMexkny N3roToBNTeneM w noTpe6NTeneM,ecnn B nocne HeM cnyuae oHn 6onbwe.T a 6 nn u a 1-Tpe6oBaHna k nepyaTkaMAe中eKT,CBA3 AHHblMypoBeHbnpenenHanMeHoBaHne noka3arensnpnemneMoroc noka3aTeneMKOHTPOKavecTBa AQLCTepnnbHOCTbHecTepnnbHbleA)epMeTN4HOCTbHannune oTBepcTnn2,5Pa3MepblHecooTBeTCTBNe MHbl,wnpn-S-24,0Hbl,TONWMHblN3MKO-MexaHn4eckne CBONCTBaHecooTBeTCTBMe noka3aTenen noS-24.0M nocne yckopeHHoro cTapeHnAMacca ocTaTouHoro onyapnBaio-几eBblL山aeT MaKcnManbHoe3HaN-5山ero Be山eCTBaHeHneMacca onyapnBaio山ero Be山eCTBanpeBblwaeTpekoMeHnyeMoeN-2MaKcnManbHoe 3HayeHne,CM.中apMakoneo CLA6 Tpe6oBaHna6.1 nepuaTKn,OTo6paHHble B COOTBeTCTBNN c pa3nenoM 5,AonKHbl COoTBeTCTBOBaTb cneAyiowMTpe6oBaHNAM.6.1.1 nepuaTkn AonxKHbl COoTBeTCTBOBaTb Tpe6oBaHMAM K CTepnnbHocTn npn npoBeneHnn ncnblTaHnn07.26.1.2 nepuaTkn gonKHbl 6blTb repMeTnyHblMn npn npoBegeHnn ncnblTaHnn no 7.3.6.1.3 Pa3Mepbl nepuaToK AonKHbl COoTBeTCTBOBaTb Tpe6oBaHMAM 7.4.6.1.4 3WKO-MexaHnueckne CBONCTBa nepuaTok AonKHbl COoTBeTCTBOBaTb Tpe6oBaHNAM 7.5.3)apMakone CWA(U.S.Pharmacopeia),nocnenHee n3naHme,Mack Publishing Co.,Easton,PA 19175.2