QA016 Disposal of Samples (Rev03)

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20090113 PI 030-1 PICS 原料药检查备忘(中英文)

2. INTRODUCTION 介绍2.1 The adoption of ICH Q7 as the first truly harmonised GMP guideline for active pharmaceutical ingredients (APIs) and the associated development of regulatory frameworks to implement the guideline as a regulatory standard mark the beginning of a new era of regulation for medicines.采用ICH Q7作为真正意义上的原料药统一GMP指南，并伴随着法规框架的发展以实施指南作为法规的标准，标志着药品法规的一个新纪元。

2.2 The adoption of ICH Q7 by PIC/S occurred in May 2001 with the current version of the guideline having been available since 1 September 2007 as GMP PE 009 (Part II).2001年5月PIC/S采用了ICH Q7，现行版本指南GMP PE 009(第二部分)在2007年9月1日公布.2.3 The primary objective for implementing ICH Q7 is the reduction of the risks associated with the manufacturing quality of APIs and this cannot be achieved without an effective inspection system which addresses the specific aspects of the global API industry.实施ICH Q7的基本目标是减少原料药生产质量所伴随的风险，要达到这个目标，必须制订有效的检查体系，以说明全球原料药行业的各个独特方面。

样品折射率及分散方法

Sample dispersion and refractive index guideMastersizer 2000Reference manualSample Dispersion and RefractiveIndex GuideMAN0396 Issue 1.0 April 2007© Malvern Instruments Ltd. 2007Malvern Instruments makes every effort to ensure that this document is correct. However, due to Malvern Instruments’ policy of continual product development we are unable to guarantee the accuracy of this, or any other document after the date of publication. We therefore disclaim all liability for any changes, errors or omissions after the date of publication. No reproduction or transmission of any part of this publication is allowed without the express written permission of Malvern Instruments Ltd.Head office:Malvern Instruments Ltd.Enigma Business Park,Grovewood Road,Malvern,Worcestershire WR14 1XZUnited Kingdom.T el + [44] (0)1684-892456Fax + [44] (0)1684-892789Printed in EnglandT able of ContentsRefractive index list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Sample dispersion guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 Sample Dispersion and Refractive Index Page iT able of Contents Sample Dispersion and Refractive Index Page ii MAN 03961 Refractive index listCompound Formula Refractive indexAcanthite (Silver Sulphide)Ag2S 2.2Acetal 1.48Acetone 1.36Adipic Acid(CH2.CH2.COOH)2 1.433Agate SiO2 1.544-1.553Albite Na2O.AI2O3.6SiO2 1.529Albite (Feldspar)NaAlSi3O8 1.527-1.538Almandine (Garnet) 1.830Alumina AI2O3 1.760Alumina trihydrate AI2O33H20 1.577-1.595Aluminium Hydroxide (Nat. Boehmite)Al(OH)2AlO(OH)1.56 - 1.751.64 - 1.67Aluminium Oxide (Corundum)Al2O3 1.76 - 1.7681.765Aluminium Silicate Al2O3.SiO2 1.65Aluminium Stearate Al(C18H35O2)3 1.49Aluminum Sulphate AI2(SO4)3 1.47Ammonium Chloride NH4CI 1.642Ammonium Sulphate NH4SO4 1.523Ammonium Dihydrogen Phosphate(NH4)H2P2O6 1.52Anatase (Titanium Dioxide)TiO2 2.49 - 2.56Andesine (Feldspar)([NaSi]0.7-0.5 [CaAl]0.3-0.5)AlSi2O8 1.544 - 1.563Sample Dispersion and Refractive Index Page 1-1Chapter 1Refractive index list Page 1-2MAN 03961 Andradite (Garnet)1.887Anglesitte (Lead Sulphate)PbSO 4 1.8771 - 1.8937Anhydrite (Calcium Sulphate)CaSO 4 1.5698 - 1.6136Anhydrite (Gypsum)CaSO 4.2H 2O 1.57 - 1.61Anhydrous BoraxNa 2O.2B 2O 3 1.501Anorthite (Feldspar)CaAl 2Si 2O 8 1.577 -1.590Anorthoclase (Feldspar)(Na,K)AlSi 3O 8 1.523 - 1.529Antimony Trioxide(Nat. Semarnontite)(Nat. Valentine)Sb 2O 3 2.0872.18 - 2.35Antimony VermilionSb 2S 3 2.65Aragonite (Calcium Carbonate)CaCO 3 1.530 - 1.686Arsenic Sulphur Glass2.61Arsenous OxideAs 2O 3 1.76 (V)1.92 (I)Asphaltum (Bitumen)1.64 - 1.66Azurite2CuCO 3.Cu(OH)2 1.73 - 1.83Baddeyelite (Zirconium Oxide)ZrO 2 2.13 - 2.20Barite (Barytes)BaSO 4 1.6362 - 1.6482Barium Carbonate (Witherite)BaCO 3 1.529 - 1.677Barium ChlorideBaCI 2.2H 2O 1.642Barium Crown Glass(Light)(Medium)(Dense)1.540651.5761.613Barium FluorideBaF 2 1.47Barium OxideBaO 1.98Barium Sulphate (Barite, Barytes)BaSO 4 1.637 - 1.649Barium Mono-sulphideBaS 2.155Barium TitanateBaTiO 3 2.40Barium YellowBaCrO 4 1.94 - 1.98Barytes (Barite, Blanc Fixe)BaSO 4 1.636 - 1.649Benzene C 6H 6 1.50CompoundFormula Refractive indexRefractive index list Chapter 1Sample Dispersion and Refractive Index Page 1-3Benzyl AlcoholC 6H 5CH 2OH 1.538-1.541Benzyl Benzoate1.568-1.570Beryllium OxideBeO 1.719Biotite (Mica)K(Mg,Fe)3 AlSi 3O 10(OH,F)2 1.565 - 1.696Bitumen1.6500Black Pigments1.675 (average)Blanc Fixe (Artificial Barytes)BaSO 4 1.638 - 1.649Blue Pigments1.63 (average)BoehmiteAlO(OH) 1.64 - 1.67Bone BlackC + Ca 3(PO 4)2 1.65 - 1.70Boracic AcidB 2O 3.3H 2O 1.456BoraxNa 2B 4O 7 1.4466 - 1.4687BoraxNa 2O.2B 2O 3.10H 2O 1.469Boric OxideB 2O 3 1.459Boro-silicate Crown Glass(Soda lime glass)1.509701.513Boron OxideB 2O 3 1.61-1.64Boron Oxide GlassB 2O 3 1.485Brick Dust1.44Brookite (Titanium Dioxide)TiO 2 2.5831 - 2.7004Brown Pigments1.653 (average)N-butanolCH 3CH 2CH 2CH 2OH 1.3993ButanoneCH 3CH 2COCH 3 1.38Butter Fat1.4548Cadmium IodideCdI 2 2.7Calcium MetaborateCa(BO 2)2 1.660Cadmium OxideCdO 1.49Cadmium RedCdS(Se) 2.64 - 2.77Cadmium Red LithoponeCdS(Se) + BaSO 4 2.50 - 2.76Cadmium Sulfide (Greenockite)CaS 2.506 - 2.529Cadmium YellowCdS 2.35 - 2.48Cadmium Yellow Lithopone CdS + BaSO 4 2.39 - 2.40CompoundFormula Refractive indexChapter 1Refractive index list Page 1-4MAN 0396Calcite (Calcium Carbonate)CaCO 3 1.486 - 1.740Calcium CarbideCaC 2 1.750Calcium CarbonateCaCO 3 1.681 (IV)Calcium Carbonate(Aragonite)(Nat. Calcite)(Nat. Vaterite)CaCO 3 1.53 - 1.6851.4864 - 1.741.55 - 1.65Calcium Carbonate HexahydrateCaCO 3.6H 2O 1.460 - 1.545Calcium ChlorideCaCI 2 1.52Calcium ChloriteCa(ClO)2.2Ca(OH)2 1.51 - 1.585Calcium Fluoride (Fluorite)CaF 2 1.43 - 1.44Calcium Hydroxide (Hydrated Lime)Ca(OH)2 1.545 - 1.574Calcium HypochloriteCa(ClO)2 1.545 - 1.69Calcium Hypochlorite Tri-hydrateCa(ClO)2.3H 2O 1.535 - 1.63Calcium Magnesium Carbonate(Dolomite)CaCO 3, MgCO 3 1.5026-1.6817Calcium Metasilicate (a)CaSiO 3 1.6350Calcium Metasilicate (b)(Nat. Wollastonite)CaSiO 3 1.6145Calcium Molybdate (Pawellite)CaMoO 4 1.97Calcium Oxide (lime) (Calcia)CaO 1.838Calcium PeroxideCaO 2 1.895Calcium PhosphateCa 3(PO 4)2 1.629(tri) Calcium PhosphateCa 3(PO 4)2 1.627Calcium Meta Silicate (a)(Nat. Pseudowollastonite)CaSiO 3 1.610 - 1.664Calcium Meta Silicate (b)(Wollastonite)CaSiO 3 1.616 - 1.613Calcium Di-ortho Silicate ICa 2SiO 4 1.717 - 1.735Calcium Di-ortho Silicate IiCa 2SiO 4 1.717 - 1.735Calcium Di-ortho Silicate IiiCa 2SiO 4 1.642 - 1.654Calcium Tri-silicate (Nat. Alite)Ca 3SiO 5 or 3Ca.SiO 2α 1.718 - β 1.724CompoundFormula Refractive indexCalcium Sulphate(Nat. Anhydrite) (Nat. Gypsum)CaSO4.2H2OCaSO4.2H2O1.569 - 1.6131.521 - 1.53Calcium Sulphide (Nat. Oldhamite)CaS 2.137Calcium Titanate CaTiO3 1.57Calcium Tungstate CaWO4 1.9185Caraway Oil 1.485-1.492 Carbon (Lamp Black, Graphite)C 2.42Carbon Tetrachloride / Tetrachlo-romethaneCCl4 1.46Cardamom Oil 1.461-1.467 Castor Oil 1.4770Castrol 1.1000Cellulose Acetate 1.46-1.5 Cellulose Acetate Butpate 1.46-1.49Cement 1.68 (average) Cerium Compounds 1.8282Cerium (iii) Orthophosphate (nat.Monazite)CePO4 1.774-1.851 Cerulean Blue CoO.ηSnO2 1.84Cerussite PbCO3 1.804 - 2.079 Chalk (Whiting)CaCOSee Calcium Carbonate1.53 - 1.68Chalcedony (Fiberous, ImpureQuartz)SiO2 1.544- 1.553 Chazabite 1.482China Clay(Kaolinite)Al4Si4O10(OH)8 1.533 - 1.577 Chloroform CHCI3 1.446Chocolate 1.5900Chrome Alum Cr2(SO4)3.K2SO4.24H2O 1.481Chrome Orange PbCrO4.Pb(OH)2 2.42 - 2.7 Chrome Green (med.)Fe4[Fe(CN)6]3 + PbCrO4 2.4Chrome Yellow (med.)PbCrO4 2.31 - 2.49 Chromic Oxide Cr2O3 2.551 Compound Formula Refractive indexChromium Cr 3.51Chromium Oxide Green Cr2O3 2.5Cigarette Ash 1.53Cinnamon Oil 1.573-1.600Clofibrate 1.500-1.505Clove Oil 1.528-1.537Coconut Oil 1.448-1.450Cobalt Blue CoO.Al2O3 1.74Cobalt Carbonate(Nat. Spherocobaltite)CoCO3 1.60 - 1.855Cobalt Ii Per-chlorate Co(ClO4)2.6H2O 1.55Cobalt Ii Per-chlorate (Needles)Co(ClO4)2 1.490-1.51Cobalt Ll Chloride Di-hydrate CoCl2.2H2O 1.625 - 1.67Cobalt Fluosilicate CoSiF6.6H2O 1.382 - 1.387Cobalt Green CoO.πZnO 1.94 - 2.0Cobalt Yellow CoK3(NO2)6.H2O 1.72 - 1.76Cobalt II Oxide CoO 1.74Cobalt Violet Co3(PO4)2 1.65 - 1.81Cocoa Butter 1.4568Cobaltous Nitrate Co(NO3)2.6H2O 1.4Cobaltus Sulphate CoSO4.7H2O 1.483Coconut Oil 1.4493Cod-liver Oil 1.481Coffee Dust 1.53Copper Cu0.25Copper II Carbonate(Nat. Malachite) (Nat. Azurite, Chessylite)CaCO3.Cu(OH)22CaCO3.Cu(OH)21.655 - 1.9091.730 - 1.838Copper L Chloride (Nantokite)CuCl 1.93Copper II Chloride Di-hydrate CuCl2.2H2O 1.644 - 1.731 Copper I Oxide (Cuprite)Cu2O 2.705Copper II Oxide (Tenorite)CuO 2.63Copper III Oxide 1.93 Compound Formula Refractive indexCopper I Sulphate (powder)Cu2SO4 1.724 - 1.739 Copper II Sulphate(Nat. Hydrocianite)CuSO4 1.733Copper II Sulphate Basic(Nat. Brochantite)CuSO4.3Cu(OH)2 1.728 - 1.800Copper II Sulphate Pentahydrate(Nat. Chalcanthacite)(CuSO4.5H2O) 1.514 - 1.543 Copper II Sulphide (Nat. Covellite)CuS 1.45 Coriander Oil 1.462-1.472 Cork Dust 1.49 - 1.65 Corn Oil (Zea Mays) 1.4734 Corundum (Ruby, Saphire)Al2O3 1.759 - 1.772 Cotton 1.459 - 1.58 Cotton Seed Oil 1.4735 Covellite (Copper II Sulphide)CuS 1.45 Cristobalite (Quartz)SiO2 1.484 - 1.487 Crotamiton 1.540-1.542 Crown Glass(Soft) (Hard)1.51516 1.51899Cryolite3NaF.AIF3 1.339Cupric Oxide CuO 2.63Cuprite (Copper I Oxide)Cu2O 2.705 Cuprous Oxide Cu2O 2.705Cyclic Ketone Resin 1.60 Cyclohexane 1.4266 Cyclohexanone 1.45 Dandruff & Epithelial Cells 1.53N - Decane CH3, (CH2) 8CH3 1.4102 Dementholised 1.456-1.466 Diglyme (Dimethyldigol orDiethylene Glycol Dimethylether)(CH3, O,CH2, CH2)20 1.4070-1.4085 Diamond C 2.4175Diatomaceous Earth (Silicon Dioxide)SiO2 1.435Compound Formula Refractive indexDichloromethane 1.42Diethyl Phthalate 1.500-1.505 Dimethyl Sulphoxide 1.478-1.479 Dill Oil 1.481-1.492 Dimer Caprol 1.568-1.574 Dimethylformamide 1.4305 Dolomite CaCO3.MgCO3 1.5026-1.6817 Dover 1.4300 Eddingtonite 1.55 Egyptian Blue CaO.CuO.4SiO2 1.605 - 1.635 E.K.2 1.74338 Emerald Green (Paris green)Cu(C2H3O2)2.2Cu (OH)2 1.71 - 1.78 Epithelial Cells (Dandruff) 1.53Epoxy 1.58Epsom Salt (Epsomite)MgSO4.7H2O 1.433 - 1.461 Ethanol CH3CH20H 1.36 Ethanediol HOCH2CH2OH 1.43 Ethanolamine H2NCH2CH2OH 1.453-1.459 Ethyl Cinnamate 1.558-1.560 Ethylene Glycol HOCH2CH2OH 1.432 Eucalyptus Oil 1.458-1.470 Feldspar(Albite) (Andesine) (Anorthite) (Anorthoclase) (Microcline) (Oligoclase) (Orthoclase)NaAlSi3O8AlSi2O8CaAl2Si 2O8(Na,K)AlSi3O8KAlSi3 O8([Na,Si]0.9-0.7 [CaAl]0.1-0.3) AlSi2 O8KAlSi3 O81.527 - 1.5381.544 - 1.5631.577 - 1.5901.523 - 1.5291.514 - 1.5391.533 - 1.5521.518 - 1.539Ferric Oxide Fe2O3 3.01Ferric Sulphate Fe2(SO4)3 1.814Ferroso - Ferric Oxide Fe3O4 2.42 Compound Formula Refractive indexFerrous Carbonate FeCO3 1.875 Ferrous Oxide FeO 2.32 Ferrous Sulphate (Copperas)FeSO4.7H2O 1.471Flint(Impure Quartz) (Telescope) (Barium) (Barium light ) (Borate) (Special barium) (Extra light)SiO21.5531.530421.604831.567131.613261.744161.54769Flint Glass (Light)(Dense)(Extra dense) (Double extra dense)1.53 - 1.96 1.57838 1.62258 1.65108 1.80120Flour Crown 1.49429Fluorite (Fluorspar)CaF2 1.433 - 1.435 Fluorspar (Avorite)CaF2 1.433 - 1.435 Fractionated Coconut Oil 1.445-1.451 Fractionated Palm Kernel Oil 1.445-1.447 Furhairs 1.54 - 1.55Fused Quartz 1.45887Gallium Antimonide GaS6 3.8 (approximately) Gallium Arsenide GaAs 3.33 (approximately) Gallium Phosphide GaP 3.39Garnet (Almandine) (Andradite) (Grossularite) (Hydrogrossularite) (Pyro pe) (Spessartite) (Uvarovite)1.779 (average) 1.8301.8871.7341.675 - 1.734 1.7141.801.86Compound Formula Refractive indexGlass(Hardcrown) (Borosilicate crown) (Medium barium crown) (Dense barium crown) (Light flint)(Dense flint)(Extra dense flint) (Double extra dense flint)1.518 1.509 1.576 1.613 1.583 1.621 1.652 1.802Glass (crown) 1.48 - 1.61 Glass (flint) 1.53 - 1.96 Glasses & Mineral Wools 1.47 - 1.62 Glycerol 1.47D-Glucose Pentaamethylether C1,H22O6 1.4466 Glycine Soja (Soybean Oil) 1.4729 Gmelinite 1.481Goethite (Ochre, Yellow) (Sienna, Raw)Fe2O2.H2O2.0 - 2.41.87 -2.17Gold Au0.28 - 0.31Green Earth 1.62Greenockite CaS 2.506 - 2.529 Green Pigments 1.811 (average) Grossularite (Garnet) 1.734D-gulcitol (D-Sorbitol) 1.333Gum 1.54Gypsum(Calcium Sulphate Dihydrate)CaSO4.2H2O 1.519 - 1.531 Hafnium Hf 3.64Hair (human) 1.54 - 1.56Halite (Rock Salt)NaCl 1.544Hardcrown Glass 1.518 Harmotome 1.5078 Hausmannite (Manganese Oxide)Mn3O4 2.15 - 2.46 Helianthus (Annus) 1.4694HematiteCompound Formula Refractive index(Iron III Oxide)Fe2O3 2.94 - 3.22 Heptane C7H16 1.39Herring Oil 1.4610 Heulandite 1.500 Hexane C6H14 1.38 Hydroglossularite (Garnet) 1.675 - 1.734 Ibuprofen 1.4364 Iceland Spar (Calcite)CaCO3 1.658 - 1.486 Insect Parts 1.54 - 1.55 Illite (Clay Minerals)K(1-1.5) Al4SiAl(1-1.5)O20(OH)4 1.54 - 1.61 Indian Yellow C19H18O11Mg.5H2O 1.67Indium Antimonide InSb 4.3Indium Phosphide InP 3.42Ink 1.5Ink-orange 1.36 Intralipid 1.46Iriduim Ir 2.53Iron Fe 2.86Iron Oxide (Nat. Magnetite)Fe3O4 2.42Iron Ii Oxide (Nat. Wuestite)FeO 2.32Iron III Oxide (Nat. Hematite)Fe2 O3 2.94 - 3.22 Iron II Sulphate(Heptahydrate, Nat. Melanterite) (Pentahydrate, Nat. Siderotil) (Tetrahydrate)FeSO4.7H2OFeSO4.5H2OFeSO4.4H2O1.471 - 1.4861.526 - 1.5421.533 - 1.535Iron III Sulphate (Enneahydrate, Nat. Coquimbite)Fe2(SO4)3Fe2(SO4)3.9H2O1.8141.552 - 1.558Iron Sulphide(Nat. Marcasite, Pyrite, Pyrrhotite)FeS2 1.56Iso - Octane(CH3)3C,CH2,CH(CH3)2 1.3914Isopar G 1.42Isopar M 1.436Isoparaffin 1.429 Compound Formula Refractive indexIsopropyl Alcohol(CH3)2CHOH 1.377-1.378 Isopropyl Myristate 1.434-1.437 Jojoba 1.465Kalinite (Potassium AluminiumSulphate)KAl(SO4)2.12H2O 1.429 - 1.456 Kaolinite (China Clay)Al4 Si4 O10 (OH)8 1.533 - 1.570 Kieserite (Magnesium Sulphate)MgSO4.H2O 1.52 - 1.58 Lactose C12H22O11.1H2O 1.54 Lanthunum Fluoride LaF 1.60Latex Rubber 1.51 Laumontite 1.5148Lead Pb 2.01Lead Carbonate (Cerussite)PbCO3 1.8036 - 2.0786 Lead Chloride PbCl2 2.217Lead Chromate (Crocoite)PbCrO4 2.29 - 2.66 Lead Dioxide PbO2 2.3Lead Fluoride PbF2 1.75Lead Glass (20% lead content) 1.54Lead Molybdate (Nat. Wulfenite)PbMoO4 2.283 - 2.403 Lead Oxide (Litharge)PbO 2.665 - 2.535 Lead Oxide (mono)PbO 2.51-2.71Lead Oxide(minim)Pb3O4 2.51-2.71Lead (red)(Lead Oxide Pigment)PbO 2.420Lead Sulphate(Anglesite) (Nat. Lanarkite)PbSO4PbSO4PbO1.82 - 1.8941.93 -2.02Lead Sulphide (Galena)PbS 3.921 Lead (white)(Basic Carbonate)(Hydro-cerussite, Cerussite)2PbCO3.Pb(OH)2PbCO31.94 -2.091.804 -2.078Lead (white)(Basic Sulphate, Lanarkite)PbSO4.PbO 1.930 - 2.02 Leather Dust 1.54 Compound Formula Refractive indexLemon Oil 1.474-1.476 Lepidolite (Mica)Kl2(Li,Al)5-6 Si6-7Al2-2O20(OH,F)4 1.525 - 1.587 Levyn 1.498 Limonene (Opticlear) 1.470 Linseed Oil 1.4782 Liquid Paraffin (Light) 1.4680 Lithium Carbonate Li2CO3 1.567 Lithium Fluoride LiF 1.3915 Lithium Mica (Lepidolite)K2(Li,Al)5-6 Si6-7Al2-1O20 (OH,F)4 1.525 - 1.587 Lithium Mica 1.554 - 1.587 Lithium Oxide Li2O 1.644Lithopone(Zinc Sulphide a Nat. Wurtzite) (Zinc Sulphide b Nat. Sphalerite)ZnS2.356 - 2.3782.368Lodestone (Magnetite)Fe3O4 2.420 Macrogol 300 (Polyethylene Glycol300)1.462-1.466 Magnesite (Magnesium Carbonate)MgCO3 1.563 - 1.7 Magnesium Carbonate (Magnesite)MgCO3 1.563 - 1.7 Magnesium Chloride MgCI2.6H2O 1.59-1.675 Magnesium Fluoride (Sellaite)MgF2 1.378 - 1.390 Magnesium Hydroxide Mg(OH)2 1.559-1.58 Magnesium Oxide (Periclase)MgO 1.7350 Magnesium Sulphate Colourless, V MgSO4.H2O 1.535 Magnesium Sulphate Colourless, IV,VMgSO4.7H2O 1.455Magnesium Sulphate(Epsomite, Epsom Salt)MgSO4MgSO4.7H2O1.561.433 - 1.461Magnetite (Iron Oxide, Hematite)Fe3O4 2.42Malachite Cu2 (OH)2(CO3) 1.655 - 1.909 Manganese Mn 2.52Manganese Blue BaMnO4 + BaSO4 1.65Manganese Carbonate MnCO3 1.817 Compound Formula Refractive indexManganese Dioxide MnO2 2.4 Manganese Oxide(Manganosite)MnO 2.16 Manganese Oxide (OUS)MnO 2.16 Manganese Oxide Mn3O4 2.46 Manganese Sulphate MnSO4.4H2O 1.508 Manganese Violet(NH4)2Mn2(P2O7)2 1.67 - 1.75 Marcasite (Iron Di-sulphide)FeS2 1.87 Methanol CH3OH 1.33 Methylmethycrylate 1.48-1.501 - Methyl Naphthalene CH3C10H7 1.62 Methyl Salicylate 1.535-1.538 Mesolite 1.506Mica (Muscovite) (Paragonite) (Phlogopite) (Biotite) (Lepidolite)see individual compounds1.552 - 1.6161.564 - 1.6091.530 - 1.6371.565 - 1.6961.525 - 1.587Microcline (Feldspar)KAlSI3O8 1.514 - 1.539 Miglyol (Coconut Oil) 1.4493Milled Glass 1.55Milk Fat 1.46Milk Serum 1.34Millerite (Nickel Sulphide)NiS 1.81Minium (Lead Sulphide)Pb3O4 2.40 - 2.44 Molybdate, Orange Pb(Mo,S,Cr,P)O4 2.55 Molybdenum Mo 3.71Monazite (cerium (III)Orthophosphate)(CeLaTh)PO4 1.774-1.851Montmorillonite (Clay Minerals)(0.5Ca,Na)0.7(Al,MhFe)4(Si,Al)8020(OH)41.48 - 1.64 Mordenite 1.4798Muscovite (Mica)KAl2 Si3 AlO10(OH,F)2 1.552 - 1.616 Mustard Oil 1.475 Compound Formula Refractive indexCompound Formula Refractive index Natrolite 1.483Neat’s Foot Oil 1.464Nickel Ni 1.98Nickel Oxide NiO 2.182Nickel Oxide (Bunsenite)NiO 2.18Nickel Sulphate NiSO4 1.48Nickel Sulphate, Hexahydrate NiSO4.6H20 1.511Niobium Nb 1.80Nutmeg Oil 1.472-1.488Nylon 1.53Ochre, Yellow (Goethite)Fe2O2.H2O 2.0 - 2.4Olea Europa Sativa (Olive Oil) 1.4679 Oligoclase (triclinic)([NaSi]0.9-0.7[CaAl]0.1-0.3)AlSi2O8 1.533 - 1.552 Olive Oil (Olea europa sativa) 1.4679Orange Oil 1.472-1.476 Orange Pigments 2.593 (average) Orthoclase (Feldspar)KAlSi3O8 1.518 - 1.539 Osmium Os 3.88Palladium 1.80Palm Oil 1.4578Palm-kernel Oil 1.4569 Paragonite (Mica)NaAl2Si3AlO10(OH)2 1.564 - 1.609 Paraffin 1.43Paraffin Wax 1.446 Paraldehyde 1.403-1.406 Peanut Oil 1.4691 Peppermint Oil 1.460-1.467 Periclase (Magnesium Oxide)MgO 1.7350Perspex 1.495Phlogopite (Mica)KMg3AlSi3O10(OH,F)2 1.530 - 1.637 Phillipsite 1.498 Phosphorous (yellow)P4 2.144Phthalocyanine Blue(Copper phthalocyanine)1.38Phthalocyanine Green(Chloro-copper phthalocyanine)1.40 Phytomenadine (Vitamin K1) 1.526-1.528Pigments (Red) (Blue)(averages) 2.5221.63Platinum Pt 4.50Poly (1,2 - Butadiene) 1.50Poly (2 - Vinyltetrahydrofuran) 1.55Poly (2 - Vinylthiophene) 1.6376 Polycarbonate 1.60Pollens & Spores 1.5Polyester Resin 1.523 - 1.54 Polyethylene (Low Density) 1.50-1.54 Polyethylene (Med. Density) 1.52-1.54 Polyethylene (High Density) 1.54 Polymethylmethacrylate 1.4760 Polypropylene 1.49Polystyrene 1.59-1.6 Polystryene Acrylonitrile 1.56 - 1.57 Polytetrafluoroethylene (PTFE) 1.30 - 1.40 Polytrifluorochloroethylene 1.43Polyvinyl Acetate (PVA) 1.395 Polyurethane 1.5 - 1.6 Polyvinylchloride (rigid) (PVC) 1.54 Polyvinylchloride (Non-rigid) (PVC) 1.50 - 1.54Poppy-seed Oil 1.4685Potash Alum(Potassium Aluminium Sulphate)KAl(SO4)2.12H2O 1.429 - 1.456Potassium Aluminium SulphateNat. Kalinite (Potash Alum)KAl(SO4)2.12H2O 1.429 - 1.456 Potassium Bromide KBr 1.55Potassium Carbonate (Pearl ash)K2CO3 1.531 Compound Formula Refractive indexCompound Formula Refractive index Potassium Chromate K2CrO4 1.726Potassium Nitrate KNO3 1.504Potassium Phosphate KH2PO4 1.50Potassium Silico Fluoride K2SiF6 1.399Potassium Iodide KI 1.677Potassium Chloride (Sylvite)KCl 1.49Propan-2-ol (IPA)(CH3)2CHOH 1.39Propylene Glycol CH3CH(OH)CH2OH 1.431-1.433 Prussian Blue Fe[Fe(CN6)]3 1.56Pumice (Volcanic Glass)[Na,K,Al] 1.500PVC 1.53PVT 1.5500Pyrolusite (Manganese Oxide)MnO2 2.4Pyrope (Garnet) 1.714Pyrrhotite (Iron Sulphide)Fe(1-0.8)S 1.56QuartzSiO2 1.544 - 1.553 (Chalcedony, Cristobalite, Flintsilica,Silicon Dioxide, TridymiteQuinacridone Violet C20H12O2N2 2.02 (average) Rapeseed Oil 1.4706Red Lead Pb3O4 2.42Red Pigments 2.522 (average) Resins - See ‘epoxy’Resin (Cyclic Ketone) 1.60Rhodium Rh 2.14MnCO3 1.816 - 1.597 Rhodochrosite(Manganese Carbonate)Rice Bran (Refined) 1.469Rocksalt (Halite, Sodium Chloride)NaCl 1.544Rubber Gum (Soft / Hard) 1.33 - 1.540Ruby (Corundum)Al2O3 1.759 - 1.763 Ruthenium Ru 4.8Rutile (Titanium Dioxide)TiO2 2.605 - 2.901Safflower Oil 1.462 Sardine Oil 1.4660 Sapphire (Corundum)Al2O3 1.767 - 1.772 Saw Dust & Wood Flour 1.53 Scolecite 1.5156 Selenium Se 2.8 (approx) Selenium Glass 2.6 (approx) Sesame Oil 1.4646 Sienna, Burnt Fe2O3 1.85 Sienna, Raw (Goethite)Fe2O3.H2O 1.87 - 2.17Silica (Crisobalite) (Quartz) (tridymite)SiO21.4871.5441.469Silicon Si 3.5 (approx) Silicon Carbide SiC 2.64 - 2.65Silicon Dioxide (Nat. Cristobalite) (Nat. Lechatelierite) (Nat. Tridymite) (Nat. Quartz)SiO21.484 - 1.4871.45881.469 - 1.4711.544 - 1.533Silicon Nitride Si3N4 2.02Silicon Oil 1.4030Silver Ag0.2Silver Bromide (Bromyrite)AgBr 2.235Silver Chloride (Cerargyrite)AgCl 2.071Silver Cyanide AgCN 1.685 - 1.940 Silver Iodide (Iodyrite)AgI 2.21Silver Nitrate AgNO3 1.729 - 1.788 Soap (Powdered) 1.500Sodium Biborate (Borax)Na2O.2B2O3.10H2O 1.469Sodium Carbonate(White, Powder HYG)Na2CO3. 1.500Sodium Carbonate (White, V)Na2CO3.10H2O 1.500Sodium Bicarbonate NaHCO3 1.500 Compound Formula Refractive indexCompound Formula Refractive index Sodium Chloride NaCl 1.5442Sodium Chloride (colourless, V)NaCl 1.520Sodium (di) Silicate Na2Si2O5 1.5-1.51Sodium Fluoride (Villaumite)NaF 1.32NaHCO3 1.50Sodium Hydrogen Carbonate(Sodium Bicarbonate)Sodium Hydrogen Sulphite NaHSO3 1.526Sodium Metaphosphate NaPO3 1.478Sodium Metasilicate Na2SiO2 1.520Sodium Metal Na 4.22Sodium Nitrate NaNO3 1.336 - 1.587 Sodium Nitrate (colourless,IIIa)NaNO3 1.587Sodium (ortho) Silicate Na4SiO4 1.53Sodium Silicofluoride Na2SiF6 1.312Sodium Sulphate Na2SO4.10H2O 1.396Na2SO4.10H2O 1.396Sodium Sulphate(colourless, IV, V,EFF)Sodium Sulphite Na2SO3 1.515-1.565 Sodium Sulphate (Anhydrous)Na2SO4 1.471-1.484D-sorbitol (D-Gulcitol) 1.333Soya Oil 1.465-1.475 Soybean Oil At 40°C (glycine soja) 1.4729Spearmint Oil 1.484-1.491 Spessartite (Garnet) 1.80Spores & Pollen 1.5Sphalerite (Zinc Sulphide b)ZnS 2.368Spinel (Magnesium Aluminate)MgAl2O4 1.71 - 1.72SPS Clay 1.4600Stannic Oxide SnO2 1.997Starch (Amylum)(C6H10O5)n 1.53Stilbite 1.4983Strontium Carbonate SrCO3 1.664Strontium Oxide SrO 1.810Strontium Sulphate SrSO4 1.624 Strontium Titanate SrTiO3 2.39 Strontium Yellow SrCrO4 2.01 Sulphur S8 1.957 Sucrose (saccharose)C12H22O11 1.538 Sugars - See SucroseSunflower-seed Oil 1.4694 Sylvine KCl 1.49050 Sylvite (Potassium Chloride)KCl 1.49Talc3MgO,4SiO2,H2O 1.589 Tantalum Ta 1.70 Tartaric Acid 1.49Tea Dust 1.530 Terpeneless Lemon Oil 1.475-1.485 Tetrachloromethane CCl4 1.46 Tetrahydrofuran (THF)CH2.(CH2)2.CH2O 1.41 Thallium Bromide TlBr 2.40 - 2.8 Thallium Bromide-Thallium Chloride TlBr-TlCl3 2.33 Thallium Bromide-Thallium Iodide TlBr-TlI 2.57 Thallium Chloride TlCl3 2.33 Theobroma Oil (Cocoa Butter) 1.456-1.458 Thomasonite 1.5225Tin IV Chloride SnCl4 1.512Tin Iodide SnI2 2.106Tin IV iodide SnI4 2.106Tin IV Dioxide (Nat. Cassiterite)SnO2 1.997 - 2.093 Titanium Ti 2.15 Titanium Barium White TiO2 25%, BaSO4 75% 1.7-2.5 Titanium Calcium White TiO2 25%, CaSO4 75% 1.8-2.0Titanium Dioxide (Anatase) (Rutile)TiO22.493 - 2.5542.616 - 2.903Compound Formula Refractive indexCompound Formula Refractive index Titanium OxideTiO2 2.49 - 2.554 (Anatase) Brown or Black, IITiO2 2.586Titanium Oxide(Brookite) Brown, I, Black, IVTiO2 2.56 - 2.90 Titanium Oxide (Rutile) Colourless (ifpure), Brown IITitanium Dioxide + Calcium Sulfate TiO2 +CaSO4 1.98 - 2.605 Tobacco Dust 1.53Toluene C6H5CH3 1.49Toners 1.42 - 2.42Tri Aluminate Ca3AI2O6 or 3CaOAI2O2 1.710Tri Aluminate Hexahydrate3CoOAI2O3GH2O 1.603Tri Calcium Phosphate Ca3(Po4)2 1.627 Triethanolamine 1.482-1.4851,1,1- Trichloroethane CH3CCL3 1.49 Trichloroethylene CHCL:CCl2 1.48Tridymite (Silicon Dioxide)SiO2 1.471 - 1.483 Tungstic Acid H2WO4 2.24Tungsten acid (ortho)H2WO4 2.24Turpeneless Orange Oil 1.461-1.473 Turpentine Oil 1.467 - 1.477 Ultramarine Blue Na8-10 Al6Si6O24S2-4 1.51 - 1.63 Ultramarine Violet 1.56Umber, Burnt Fe2O3 + MnO2 2.2 - 2.3Umber, Raw Fe2O3 + MnO2 + H2O 1.87 - 2.17Urea-formaldehyde 1.54 - 1.56 Uvarovite (Garnet) 1.86Van Dyke Brown (Bitumous earth) 1.62 - 1.69 Vanadium V 2.35Vanadium Pentoxide V2O5 1.52Vermilion HgS 2.8 - 3.14Violet Pigments 1.739 (average)Compound Formula Refractive index Viridian (Chromium oxide,transpar-Cr2O3.2H2O 1.82 - 2.12ent)Volasil 244 1.394Volasil 245 1.394Volasil 344 1.397Volcanic Glass Na,K,Al silicate 1.500Vinyl Chloride Acetate 1.5-1.55Water H2O 1.33Waxes (Average) 1.458Whale Oil 1.460White Lead2PbCO3.Pb(OH)2 1.94 - 2.09White Pigments (Transparent) 1.566 (average) White Pigments (Opaque) 2.132 (average) White Spirit 1.43 - 1.44 Whiting (Chalk)CaCO3 1.510 - 1.645 Witherite (Barium Carbonate)BaCO3 1.529 - 1.677 Wood Flour 1.53Wool, Human Hair 1.54 - 1.56 Wurtzite (Zinc Sulphide a)ZnS 2.356 - 2.378 Xylene (1,2 - Dimethyl benzene)C6H4(CH3)2 1.496Yellow Pigments 2.187 (average) Yttrium Molybdate Y2(M0O4)3. 4H2O 2.03Yttrium Sulphate Y2(SO4)3 1.55Yttrium Sulphate (Octahydrate)Y2(SO4)38H2O 1.543-1.576Zea Mays (Corn Oil) 1.4734Zeolite 1.5026 (average) Zinc Ammonium Solenate Sn(Se04)(NH4)2.Se42 6H2O 1.52 - 1.53Zinc Bromate Zn(BrO3)2.6H2O 1.5452Zinc Carbonate (Smithsonite)ZnCO3 1.618 - 1.818Zinc Carbonate (White, IIIa)ZnCO3 1.818Zinc Cesium Sulfate 6H2O ZnCe3(SO4)3 1.50 - 1.50Zinc Chloride ZnCl2 1.68 - 1.71Zincite (Zinc Oxide)ZnO 2.01 - 2.02 Zinc (ortho) Phosphate Zn3(PO4)2.4H2O 1.572-1.665 Zinc Oxide (Nat. Zincite)ZnO 2.008Zinc Oxide White, AM, III ZnO 2.008Zinc Selenide ZnSe 2.631Zinc Silicate (Hemimorphite)2ZnO.SiO2.H2O 1.64 - 1.636Zinc Sulfide (Wurzite) (Sphalerite) (Cleartran™)ZnS2.356 - 2.3782.3682.368Zinc White ZnO 2.00, 2.02Zinc Yellow4ZnO.4CrO3.K2O.3H2O 1.84 - 1.9Zircon (Zirconium Orthosilicate)ZrSiO4 1.92 - 2.02 Zirconium 2.32Zirconium Oxide (Nat. Baddeyelite)ZrO2 2.13 - 2.2 Zirconium OxideWhite (pure), yellow-brown, V, H7.5ZrO2 2.19Zirconium (ortho) Silicate ZrSiO4 1.92-2.02 Zirconium Silicate (Zircon)ZrSiO2 1.92 - 1.96 Zirconium Sulfide ZrS2 1.923 - 2.015 Zircosil 1.9700 Compound Formula Refractive index2 Sampledispersion guideMaterial Dispersant Additives UltrasonicsAlbumen Methanol 1 minute in ultrasonic bath Albuterol Iso-octane 1 minute in ultrasonic bath Alkali Salts cyclohexanoln-butanal,n-butylamine,linseed oilxyleneAlumina (Al2O3)Water (de-ion-ised optional)None NoneWater Sodium Hexametaphos-phate5 mins. in ultrasonic bathWater Igepal CA-630Water Tetra-SodiumPyrophosphate15 mins. in ultrasonic bathWater Daxad 11 2 mins. via probe plus40% in ultrasonic bathcontinuously to tank.Aluminium Water Igepal CA-630Sodium Hexametaphosphate 5-10 mins. in ultrasonic bathAluminium Trihydrate Water Igepal CA-630 5 mins. in ultrasonic bath Amylodipin Berylate Sunflower oil12 mins. in ultrasonic bath Ammonium Perchlorate Butyl Acetate10 mins. in ultrasonic bath Ammonium Phosphate AcetoneAmoxycillin DimethyldigolChapter 2Sample dispersion guide 2Anthracite Water Trinatrium Phosphate orPerminal BXAntimony Oxide(Sb2O3)Water Igepal CA-630 3 mins. in ultrasonic bathAntimony Trioxide Water Mix powder in neatIgepal CA-630 beforediluting 30 secs - 2 mins. in ultra-sonic bathArsenates Water Sodium PyrophosphateArsenious Oxide Octyl AlcoholCyclohexanolLiquid Paraffin2% Fatty AcidAsh Water Sodium PyrophosphateAtecortin Liquid Paraffin 5 mins. in ultrasonic bath Azodicarbonanide IPA 5 mins. in ultrsonic bath Barium Carbonate Water SodiumHexametaphosphate3 mins. in ultrasonic bathBarium Hexaferrite(BaFe12O19)WaterBarium Strontium Carbonate Water-Ethanol mixtureBarium Sulphate WaterWater-Metha-nol mixture Sodium Hexametaphosphate or Lissapol NX (Alkylphe-nol/ Ethylene Oxide condensate) non ionic.Barium Titanate Water Igepal CA-630 5 mins. ultrasound byprobe.Barytes Water SodiumHexametaphosphate orSodium PyrophosphateBentonite Propan-2-olWater Make slurry in SodiumHexametaphosphatesolutionBeryl Water Sodium Silicate orSodiumHexametaphosphateMaterial Dispersant Additives Ultrasonics。

浅谈检验检测机构检毕样品处置

浅谈检验检测机构检毕样品处置■ 何婧芳〔山西省检验检测中心（山西省标准计量技术研究院）〕摘要：随着检验检测实验室的现代化和精细化，检测机构面临着日益复杂的检测需求以及检测目的的变化，样品形态多样，检测需求变化多端，检毕样品处置要求也各不相同。

本文旨在通过探讨理化实验室检毕样品处置的原则、分类、要求等，对实验室的检毕样品，尤其是有害物质进行规范化处理，加强实验室安全检查与安全隐患的督促整改，提升安全意识，从源头上降低安全事故发生概率，并减轻环保压力，降低经济成本，推进检验检测实验室标准化建设进程。

关键词：检毕样品，处置要求，处置原则DOI编码：10.3969/j.issn.1002-5944.2024.01.032Discussion on the Disposal of Samples after Inspection by Inspection andTesting InstitutionsHE Jing-fang（Shanxi Inspection and Testing Center / Technology Institute of Standard and Metrology of Shanxi Province）Abstract:With the modernization and refinement of inspection and testing laboratories, testing institutions are facing increasingly complex testing needs, changes of testing objectives, diversity of samples, variable testing requirements, different requirements of disposal of samples after inspection. The purpose of this paper is to explore the principles, classiﬁ cations, and requirements for the disposal of samples after tested by physics and chemistry laboratories. The paper requires conducting standardized operations to deal with samples after inspection, especially harmful substances. Also, the supervision of safety inspections and the rectiﬁ cation of safety hazards in laboratory should be enhanced, safety awareness should be promoted, probability of safety accidents should be reduced from the source, the environmental pressure and economic costs should be reduced, and the standardization construction process of inspection and testing laboratories should be promoted.Keywords: sample after inspection, disposal requirement, disposal principle0 引言检测样品对检验检测机构的重要性不言而喻，是检验检测机构赖以生存的重要基础，是一切检验工作的前提和必要条件。

SAES-A-206 Positive Material Identification

Engineering Standard SAES-A-206 31 May, 1998Positive Material IdentificationMaterials and Corrosion Control Standards CommitteeSaudi Aramco DeskTop Standards Table of Contents1 Scope2 Conflicts And Deviations3 References4 Definitions5 Responsibilities6 Extent Of Verification7 Procedures8 Methods9 Acceptance Criteria10 Rejection Procedures11 Records And Reports12 Inspection13 Marking And Color Coding1 Scope1.1This standard covers the minimum mandatory requirements for positive material identification (PMI) of ASME 831.3,831.4, and 831.8 piping components, including welds, and other piping or equipment where specified in the SAMS catalog description or purchase order. This standard is applicable if these components or weldments .are manufac.tured from.alloy ~teels, stainles~ ste~ls, or nonferrous alloys, and are In contact wIth the servIce fluIds, or as specIfied In the purchase order 1.2 The requirements in this standard shall apply to PMI of both new components and repair or replacement components. The requirements apply to plant, shop, and field fabrication.Commentary Note:Testing similar to that described in this standard should also be employed whenever it is suspected that anexisting system contains the wrong material.1.3 Unless specifically required in the purchase order or subcontractor requisition, the following components and materials are exempt from PMI:(1) Nonpressure components that are not welded to alloy pressure components.(2) Pressure and nonpressure components from carbon steel or cast irons.(3) Rotating equipment internals, and associated seal, lube oil, cooling water and steam equipment and piping.( 4) Valve internals, with the exceptions of critical service isolation valve, safety valve, and relief valve internals.(5) Piping components in ASME 831.3 Category D Service or equivalent.1.4 If specified in a purchase order or SAMS catalog description, PMI is required for operationally important nonpressure components. Also, PMI of replacement components shall be required.Commentary Note:Examples of important nonpressure components would include, but not be limited to, trays for distillationcolumns and certain load bearing supports.1.5 This standard is intended to ensure that the nominal composition of the base materials and associated welds have been correctly supplied and installed as specified. The testing methods outlined in this standard are not intended to establish the complete conformance of a material to the material specifications.1.6 Where applicable, this entire standard shall be attached to and made a part of purchase orders.2 Conflicts And Deviations2.1 Any conflicts between this standard and other applicable Saudi Aramco Engineering Standards (SAESs), Materials System Specifications (SAMSSs), Standard Drawings (SASDs), or industry standards, codes, and forms shall be resolved in writing by the Company or Buyer Representative through the Manager, Consulting Services Department of Saudi Aramco, Dhahran.2.2 Direct all requests to deviate from this standard in writing to the Company or Buyer Representative, who shall follow internal company procedure SAEP-302 a1!,.d forward such requests to the Manager, Consulting Services Department of Saudi Aramco, Dhahran. .3 ReferencesThe selection of material and equipment, and the design, construction, maintenance, and repair of equipment and facilities covered by this standard shall comply with the latest edition of the references listed below, unless otherwise noted.3.1 Saudi Aramco DocumentsSaudi Aramco Engineering ProcedureSAEP-302 Inst1'llctionsfor Obtahlhlga Waiver of a Mandatoly Saudi Aramco EnghleerhlgRequirementSaudi Aramco Inspection Requirements175-320300 Inspection Requirements: Positive Material Identification (PMI)3.2 Industry Codes and StandardsAmerican Society ofMechanical EngineersASMEBoiler and Pressure Vessel Code Section II: Parts A, B andC.ASMEB16.20 Spiral-WoundGasketsASMEB31.3 Chemical Plant and Petroleum Refinely PipingASME B31, 4 Pipelille Transportation Systems for Liqlfid Hydrocarbons and Other Liqlfids ASMEB31,8 Gas Transmission and Di.'itriblftion Piping SystemsAmerican Society for Testing and MaterialsASTM A 193 Standard Specification,for Alloy-Steel and Stainless Steel Bolting Material.'i for High- Temperaflfre ServiceASTM A 262 Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels ASlM A 751 Standard Methods Practices and Tenninology.for Chemical Analysis of SteelProdlfctsPipe Fabrication Institute ...PFI ES-22 Recommended Practice for Color Coding of Piping Materials4 DefinitionsAlloy: A nonferrous alloy, alloy steel, or stainless steel. Also, an adjective referring to these materials.Alloy Steel: Any steel that contains specified quantities of elements, such as chromium, nickel or molybdenum, that are added to enhance mechanical or physical properties, and/or corrosion resistance. Alloy steels and stainless steels comprise ASME P-Nos. 3 through 11, or equivalent.PMI: Positive Material Identification --determination that the nominal chemical composition of a mechanical component is as specified and ordered.Equipment Manufacturer: The company responsible for the plant or shop fabrication of pressured equipment that is within the scope of this standard.Piping Fabricator: The company or agency responsible for the shop fabrication of piping that is within the scope of this standard.Field Fabricator: The company or agency responsible for the field fabrication of piping and pressured equipment within the scope of this standard.Material Specifications: ASME Section II, Parts A, Band C, or the relevant ASTM, or any other material specification required.Material Supplier: An organization that supplies pressure components and parts material to the Piping or Field Fabricator.Nonferrous Alloys: Metals that are not iron-based, including nickel alloys and other corrosion-resistant alloys. ASME P-No. 21 and higher, or equivalent.Nonpressure Components: Items that are not part of the pressure containing envelope, and, therefore, do not affect the pressure retaining capacity of pressured components.Pressure Product Components and Parts: Product forms used for the fabrication of pressured piping and equipment, including but not limited to: shells, heads, tubesheets, nozzles, tubes, stud bolts/nuts, gaskets, forging, flanges, pipe and fittings such as tees, elbows, reducers, and special pipe compoRents, valves (body and bonnets), and alloy "- welds joining pressure parts to nonpressure parts.Saudi Aramco Inspector: The person or company authorized by the Saudi Aramco Inspection Department to verify implementation of the requirements of this standard.SAMS: Saudi Aramco Material System. .,5 ResponsibilitiesThe Equipment Manufacturer, Piping Fabricator or Field Fabricator, as applicable, is responsiblefor ensuring that procedures are implemented in order to verify the nominal , chemical compositions of the alloy pressure containing components. The Saudi Aramco Inspector is responsible for verifying that the requirements of this SAES have been satisfied.6 Extent Of Verification6.1 The PMI program covers alloy pressure-containing components in shop and field fabricated equipment and piping (both base metal and welds) and materials used for repair or replacement of pressure containing components.6.2 One hundred percent PMI shall be performed on all pressure components and welds of alloy materials, within the scope of this standard, with the following exceptions:(1) Tubes for shell and tube and air-cooled heat exchangers and for fired process heaters and boilers: 10 tubes or 10%, whichever is greater, from .every heat number shall be chosen at random and tested prior to the installation of tubes into tubesheets.(2) This testing frequency shall also apply to any replacement tubes for equipment listed in 6.2 (1).6.3 PMI of weld material shall be performed in the same manner as for the adjacent base metal.6.4 The required number of PMI tests shall be as follows:(1) One test for each pipe spool component.(2) One test for any component that makes up part of the pressure boundary.(3) For nonpressure components, 10 pieces or 10%, whichever is greater, from each heat or lot.(4) One test for each pressure boundary weld and for all welds between nonpressure parts and pressure parts.6.5 The elements of the basic alloy materials to be verified shall be in accordance with Table 1. Table 1Basic Alloy Elements to be VerifiedCarbon-Molybdenum, Manganese-Molybdenum, Chromium and Molybdenumand Chromium-Molybdenum steelsNickel steels NickelRegular carbon grade stainless steels Chromium, Nickel, and MolybdenumLow-carbon stainless steels Chromium, Nickel, Molybdenum, and Carbon (or ASTM A 262-A) Stabilized stainless steels Chromium, Nickel, Molybdenum, Titanium and NiobiumNickel-based alloys Nickel, Iron, Copper, Chromium, and Molybdenum Copper-based alloys Copper, Zinc, and other elements specified in purchase order or SAMS catalog description 6.6 For alloys not covered in Paragraph 6.5, the Supervisor of the Materials Engineering Unit ofME&CCD/CSD shall be consulted.6.7 All field welds and any additional materials and welds made to modify prefabricated assemblies shall be PMI tested.7 Procedures7.1 The Equipment Manufacturer, Piping Fabricator or Field Fabricator, as applicable, shall implement a written PMI Procedure, covering testing and reporting, which shall be made available to the Saudi Aramco Inspector for review, acceptance, and verification of implementation.7.2 The Equipment Fabricator, Piping Fabricator, or Field Fabricator shall ensure that PMI is performed prior to completion of fabrication in the shop or at the site, for welds and for field-assembled items not previously positively identified.7.3 The Saudi Aramco Inspector shall have the option to witness any or all of the "' PMI testing. 7.4 PMI shall not be considered as a substitute for the required materials test reports.7.5 Material test reports shall not be considered as an alternative to PMI and the requirements of this standard.7.6 Each Equipment Fabricator, Piping Fabricator, and Field Fabricator shall use only trained, qualified, and experienced operators to perform PMI activities. Operator records attesting to such training, qualification and experience shall be available for Saudi Aramco review and approval. 7.7 For repair and maintenance work performed by Company personnel, alloy materials from the SAMS do not have to be retested if they are properly marked and color coded as indicated in Paragraph 13. Unidentified materials, for applications within the scope of this standard, are subject to PMI by the Inspection Department.8 Methods8.1 The instruments and methods used shall be suitable for identifying the material by quantitative measurement of the major alloying elements required in the ~ applicable material specification or welding procedure specification.8.2 The acceptable method is X-ray emission analysis, also known as X-ray fluorescence (XRF) analysis with a calibrated portable instrument such as the TN Technologies A11oy-Analyzer 9266, TN Technologies Metallurgist XR 9277, Cianflone Scientific Portaspec 2501, or Outokumpu Electronics X-MET 880 analyzer. Other instruments using the same analytical method may be used provided they are calibrated and they demonstrate equivalent performance.8.3 As an alternative, a chemical analysis of samples cut out from the pieces requiring PMI, in accordance with one of the methods in ASTM A 751, may be used to check for the alloying elements required by this standard.8.4 Low carbon stainless steels shall be alloy verified by both an ASTM A 262 (Practice A) test and X-ray emission analysis or chemical analysis of the major alloying elements. Alternatively, an optical emission spectrograph similar to an Arc-Met 930 SP, or similar equipment with proven capability, may be used to check for all the required elements, including carbon. All burn damage shall be removed by grinding.8.5 Prior to commencing PMI, instrument operators shall be qualified to operate approved equipment on a representative sample of the alloy materials with 100% correct assessment as the performance criteria. The instrument operator " shall work to a written procedure and shall have been trained to use the instrument in accordance with that procedure. Training shall be documented.8.6 If sample removal is used, a written procedure for identification and traceability to original material is required.8.7 PMI of welds shall be done after removal of slag and/or oxide from the weld surface. Where accessible, both inside and outside weld surfaces shall be alloy verified.8.8 The surface to be analyzed shall be clean.-bare metal, free of grease or oil, with a surface finish as specified by the instrument manufacturer.Commentary Note:Generally a fresh 60 grit finish is required for the Arc-Met, while no minimum surface finish is required for the Texas Nuclear, only that the surface be clean bare metal.9 Acceptance Criteria9.1 For acceptance, it must be demonstrated that materials contain the amounts of alloying elements shown in the material specification. Alloys shall be acceptable if the alloying elements are each within 10 percent of the specified range of values.9.2 Welds with consumables that match, or nearly match, the base metal composition shall be within +/-12.5 percent of the ranges allowed in ASME Section IIC for each element.9.3 Acceptance criteria for dissimilar metal alloy welds shall be in accordance with the welding consumable specified in the approved welding procedure. The effects of dilution between the different base metals and the filler metal shall be taken into account for determining the nominal as-deposited weld metal composition.10 Rejection Procedures10.1 If the PMI results fall outside the acceptable range using the methods described in Section 8, the Equipment Manufacturer, Piping Fabricator, or Field Fabricator, has the option to obtain a chemical analysis performed by an independent testing laboratory. The independent laboratory must be acceptable to the Saudi Aramco Inspector. The results of this independent chemical analysis shall govern.10.2 If any component or weld is found unacceptable, it shall be replaced and the replacement shall be alloy verified in accordance with this standard.10.3 Procedures shall be in place to ensure that rejected components are segregated and properly identified to prevent reuse.10.4 Where tubes for heat exchangers, fired process heaters, and boilers are found unacceptable, all tubes required of the particular alloy shall be tested for the individual equipment.10.5 All rejected tubes shall be replaced and the replacement tubes shall be subjected to PMI in accordance with this standard.10.6 If any of the samples of nonpressure components fail to meet the acceptance criteria, the full order shall be tested.11 Records And Reports11.1 Records11.1.1 Shop Fabrication11.1.1.1 A detailed recording/logging procedure shall be prepared by the Equipment Manufacturer or Shop Fabricator.11.1.1.2 The log shall identify each component and weld corresponding to an individual equipment item or piping spool and shall include the equipment or spool number and purchase order number.11.1.1.3 The log shall identify all components and welds that have been alloy verified and the results of testing.11.1.1.4 Test results shall include measured percentages of alloying elements for components that were accepted or rejected and for those components that were rejected but accepted based on independent chemical analysis.11.1.1.5 The Equipment Manufacturer shall prepare a detailed PMI map of the pressured equipment being fabricated. The map shall show the alloy material specification of each alloy component and the extent of PMI required in accordance with this standard.11.1.2 Field Fabrication11.1.2.1 At least two weeks prior to the commencement of fabrication, the Field Fabricator shall establish and present to the Saudi Aramco Inspector for review the proposed testing, logging, identification, and final installation procedures for all components requiring PMI testing onsite ( such as fabricated pressured equipment, piping, valves, and welds).11.1.2.2 Shop-fabricated alloy pressure equipment, assemblies, or piping that have been alloy verified by the Piping Fabricator need not be re-verified in the field. However, the Field Fabricator shall have available, for review, the Piping Fabricator's report of PMI. Material certificates are not allowable substitutes.11.2 Final Report11.2.1 Prior to final acceptance of alloy pressured equipment or piping, the Equipment Fabricator or Field Fabricator shall prepare a complete PMI Report containing all relevant data. For pressured equipment, the PMI , Report shall be included as part of the Equipment Data Book.11.2.2 The PMI Report shall be reviewed by the Saudi Aramco Inspector prior to final acceptance.12 InspectionMaterials shall be subject to inspection by the Saudi Aramco Inspector in accordance with Saudi Aramco Inspection Requirement 175-320300.12.1 The responsible Inspection Organization shall ensure and verify that the correct new materials ordered by local area Maintenance organizations have been verified by PMI as required. If the materials are not properly marked and color coded, they shall be verified by one of the methods in Paragraph 8.12.2 During repairs or alterations of materials required to be PMI tested, the responsible Inspection Organization shall verify the correct compositions of the shop and field welds made by local welding agencies by one of the methods in Paragraph 8.13 Marking And Color Coding13.1 Verification Marking13.1.1 Marking shall be done with water-insoluble material that contains no substances that harmfully affect the metal at ambient or elevated temperatures. In particular, the marking material shall be free of lead, sulfur, zinc, cadmium, mercury, chlorine, or other halogens.13.1.2 All components, and welds that are found unacceptable shall be marked immediately with a circled red "X" pending resolution in accordance with Section 10.13.1.3 All verified materials with an acceptable analysis shall be marked with the letter ‘PMI’ usinga certified low-stress stamp. The marking shall be placed as follows:Pipe: One mark, 75 mm from one end on the outer surface of the pipe. This marking shall be in addition to the requirements of PFI ES-22.Welds: Adjacent to the welder's mark on the weld. (Welds on tubes for heat transferequipment shall be marked by either stenciling or vibro-etching on the tubesheet).Fittings and Forgings: Adjacent to the manufacturer's markings.Valves: Adjacent to the valve manufacturer's markings on bodies and other pressure parts.Castings: Adjacent to the casting manufacturer's markings and heat numbers.Plates: 75 mm from one edge, adjacent to manufacturer's markings.Tubes: Stenciled, 300 mm from each end.13.1.4 When heat treating is performed after PMI, the identification marking must be recognizable after heat treatment. PMI markings shall be transferred when a plate or pipe is cut.13.2 Color Coding13.2.1 The color coding system for material identification described herein is intended to help prevent fabricators from using incorrect alloy material. The principal purpose of color coding is visual identification during storage and after the components have been cut for fabrication.13.2.2 Color coding is not a substitute for other, permanent manufacturers' markings required by ASTM or other specifications. Permanent manufacturers' markings shall not be obscured by color coding.13.2.3 A procedure shall be established in accordance with Section II to ensure that all alloys are verified before the color coding. Color coding need not be retained after painting.13.2.4 Prior to coding, surfaces shall be clean and free of dirt, loose scale, and oil. Paints used for coding shall be durable, bright, and distinctive and shall not contain substances that would harmfully affect the material at ambient or elevated temperatures. In particular, paints shall be free of lead, sulfur, zinc, cadmium, mercury, chlorine, and other halogens.13.2.5 Each component shall be coded in accordance PFI ES-22, and shall have painted characters indicating the specification number of the material if it is not permanently marked or tagged according to the applicable material specification.13.2.6 Valves, flanges, and fittings do not require color coding if these components are permanently stamped or tagged by the manufacturer. If the materials are not easily legible, valves, flanges, and fittings shall be coded with a stripe of 5 mm minimum width. The color coding on valves should indicate the valve body material.13.2.7 ASTM A 193, Grade 87 stud bolts do not require color coding if the grade of the material is stamped on one end of each bolt.13.2.8 Spiral-wound gaskets shall be color coded in accordance with ASME 816.20. Sheet type gaskets do not require color coding.13.2.9 Pipe and Fittings: Each length ofpipe and fitting shall have a 5 mm or larger stripe running full length. One inch NPS and smaller may have a 3 mm stripe running full length.13.2.10 Valves: When required, stripe across the body from flange to flange or end to end.13.2.11 Flanges: When required, stripe across edge up to hub.13.2.12 Bolting: When required, stripe around the midpoint of each bolt or stud.13.2.13 Plate, sheet, and strip: Stripe on surface near two perpendicular edges for entire length. 13.2.14 Tubes and Bars: Stripe entire length. ,Revision Summary31 May, 1998 Standard renumbered from SAES-L-O71 to SAES-A-206 "Positive Material Identification" and revised to apply to all components of pressured piping and equipment manufactured from alloy steels, stainless steels, or nonferrous alloys. Document responsibility transferred to Materials and Corrosion Control Standards Committee.。

LookOut Mycoplasma PCR Detection Kit 产品说明书

User GuideLookOut®One-Step Mycoplasma PCR Detection Kit MP0050-25TST (25 reactions)MP0050-100TST (100 reactions)Storage Temperature 2–8 °CProduct DescriptionThe LookOut® Mycoplasma PCR Detection Kit utilizes the polymerase chain reaction (PCR), which was established as the method of choice for highest sensitivity in the detection of Mycoplasma and Acholeplasma contamination in cell cultures and other culture-derived biologicals. Detection requires as little as 10-20 fg of mycoplasma DNA corresponding to10-20 mycoplasma per sample volume.The primer set is specific to the highly conserved rRNA operon, or the 16S rRNA coding region in the mycoplasma genome. This allows for detection of all Mycoplasma, Acholeplasma, and Ureaplasma species tested so far, which are typically encountered as contaminants in cell cultures.Eukaryotic and bacterial DNA are not amplifiedby this kit.Just one protocol is needed for the detection of all mycoplasma species. The detection procedure can be performed within 3 hours. The PCR mix also provides internal control DNA, which results in a 190 bp band on the agarose gel to indicate a successfully performed reaction.Precautions and DisclaimerThis product is for R&D use only, not for drug, household, or other uses. It is not for clinical diagnostics or testing of human samples. Please consult the Material Safety Data Sheet for information regarding hazards and safe handling practices. ComponentsDescription QuantityCatalogueNumberPCR Mix, aliquotedfor 25 reactions:1 vial MP0050-25TST4 vials MP0050-100TST Lyophilized Taq polymerase, primers and deoxynucleotide triphosphates dATP,dCTP, dGTP and dUTPReaction Buffer,1.3 mL1 vial MP0050-25TST2 vials MP0050-100TST Positive Control DNA 1 vialLyophilized syntheticDNA, non-infectiousWater, 2 mL 1 vialStorage/StabilityKit components are stable during shipping at ambient temperature. Upon receipt, store at 2-8 °C. After rehydration of the PCR mix, the positive control, and the internal control, store below –18 °C and avoid repeated freezing and thawing. For repeated testing of a few samples at a time, PCR mix and controls should be aliquoted after rehydration. By following these recommendations, the kit is stable until the expiration date stated on the label.Rehydration Buffer PCRMixWater PositiveControl DNAQuick Start GuideThis procedure overview is not a substitute for the detailed instructions.Reagent PreparationCentrifuge PCR Mix and Positive Control DNAPreparationof PCR ReactionsLoad the test tubes Aliquot 23 µL PCR MixCentrifuge brieflyStart PCR Reaction1 cycle 94 °C for2 min 39 cycles 94 °C for 30 sec 55 °C for 30 sec 72 °C for 30 sec Hold at 4-8 °CIncubate for 5 min at room temperatureVortex brieflyCentrifuge for 5 seconds600 µL300 µLAdd 2 µL Sample Add 2 µL Sample Add 2 µL Positive Control DNA Add 2 µL Fresh CellCultureMediumProcedurePreparation of Sample MaterialCell lines should be pre-cultured in the absence of antibiotics for several days to maximize test sensitivity. Samples should be derived from cultures that are at 90–100% confluence. PCR-inhibiting substances may accumulate in the medium of older cultures. For these sample materials a DNA extraction is strictly recommended prior to testing.To avoid false positive results, it is recommended to use deionized, DNA-free water, aerosol-preventive filter pipette tips, and gloves.Templates for PCR analysis are prepared by boiling the supernatant of cell cultures or other biologicals for 10 minutes as follows:1.Transfer 100 µL of supernatant from the test culture to asterile microcentrifuge tube (T0447). The lid should be tightly sealed to prevent opening during heating.2.Heat the sample supernatant at 95 °C for10 minutes.3.Briefly centrifuge (5 seconds) the sample supernatant to pelletcellular debris before adding to the PCR mixture. Rehydration of the Reagents1.Before rehydrating the tubes, centrifuge the tubes to ensurethat the lyophilized components are spun down (5 seconds at maximum speed).2.Add the appropriate amount of Rehydration/Reaction Buffer(blue cap)PCR Mix, 300 µL per portion of 25 reactions 3.Add the appropriate amount of Water (white cap) to PositiveControl DNA, 600 µL4.Incubate for 5 minutes at room temperature.5.Vortex and centrifuge again.6.Keep reagents on ice and store below -18 °Cafter rehydration. Thermal ProfileThe programming process of your cycler is explained in the instrument’s manual.Thermal Cycle Program1 cycle 94 °C for2 minutes39 cycles 94 °C for 30 seconds55 °C for 30 seconds72 °C for 30 secondscool down to 4–8 °CThe PCR MastermixTotal volume per reaction is 25 µL. When setting up reactions, calculations should also include positive and negative controls.1.The rehydrated PCR Mix can be prepared for25 reactions, aliquoted as needed, and stored b elow –18 °C forup to 3 months. Aliquot 23 µLof the rehydrated PCR Mix into each PCRreaction tube.2.Add 2 µL of deionized, DNA-free water as a negative controlinto negative control reaction tubes and seal t o avoidcontamination.3.Add 2 µL of sample (as previously described)to PCR reaction tube per sample being testedand seal.4.Pipette 2 µL of positive control DNA into positive controlreaction tube.5.Proceed to thermal cyclingAgarose Gel Rune 1.5% standard agarose gel (A9539)with 5 mm comb.2.Load 5 µL of each PCR reaction, mixed with gel trackingloading solution (G7654) per lane.3.Stop electrophoresis after 2 cm run distance (depending onthe electrophoresis chamber used e.g., run for 25 minutes at100 V).ResultsGel Evaluation1. A distinct 190 bp band should appear in every lane indicating asuccessfully performed PCR. This band may fade out with increased amounts of amplicons formed, caused by mycoplasma DNA loads of 5 × 106 copies/ml. 2. No amplification of positive control DNA maybe due to the following reasons:• positive control DNA tube has not been spun down before rehydration • programming mistake •pipetting mistake.3. Before rerun of a negative and a positivecontrol, please check thermocycler protocol and pipetting scheme.4. Nonspecific bands on the gel are extremely rare. Possibleprimer self-annealing produces another (primer dimer) band of 80-90 bp but does not affect the precision or results of the test. 5. If the PCR of a sample is inhibited, PCR inhibitors can easily beremoved from the sample by performing a DNA extraction with a commercially available kit (G1N10, G1N70, or NA2000).Sample Data← 270 bp positive control ← 190 bp internal controlR a i n b o w l a d d e rN e g a t i v e c o n t r o lP o s i t i v e c o n t r o lC o m p l e t e l y i n h i b i t e dI n h i b i t e dT y p i c a l c o n t a m i n a t i o nS t r o n g c o n t a m i n a t i o nR a i n b o w l a d d e rRelevant amplicon sizesInternal control 190 bpMycoplasma sp.(see Detectable Species)∼270 bpResults of successfully performed PCRPCR sample Band pattern Negative control Band at 190 bpPositive control Band at 267 bp,possibly an additionalband at 190 bp Interpretation of possible band patterns Band pattern InterpretationBand at 190 bp Negative sample Bands at 270 bpand 190 bpMycoplasma-positivesample with weakcontaminationStrong band at 270 bp Mycoplasma-positivesample with strongcontaminationNo band PCR inhibitionDetectable SpeciesA large number of Mollicutes sequences have been published. The primers of the kit were aligned againstthe NCBI data and scrutinized for homologies within the target region of the 16S rRNA. At least 1 Ureaplasma, 7 Acholeplasma and 85 Mycoplasma show highly relevant sequence homologies and are presumably detected as positive.Positive (Mollicutes)NegativeEP 2.6.7 listed bacteria Other microorganisms MammalsAcholeplasma laidlawii Clostridium acetobutylicum Chlamydia trachomatis Vero-B4 Mycoplasma arginini Lactobacillus acidophilus Legionella pneumophila Per.C6 Mycoplasma arthritidis Streptococcus pneumoniae Micrococcus luteus RK13 Mycoplasma fermentans Candida albicans CHO-K1 Mycoplasma gallisepticum Enterococcus faecalis Murine genomic DNA Mycoplasma genitalium Enterobacter aerogenes Calf thymus DNA Mycoplasma hominis Escherichia coli Proteus Fetal bovine serum Mycoplasma hyorhinis Proteus mirabilisMycoplasma orale Bacillus cereusMycoplasma penetransMycoplasma pneumoniaeMycoplasma salivariumMycoplasma synoviaeSpiroplasma citriUreaplasma urealyticumThe life science business of Merck operates as MilliporeSigma in the U.S. and Canada.Merck LookOut and Sigma-Aldrich are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources.NoticeWe provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledge and ability, but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies in respect to any rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking the suitability of our products for the envisaged purpose.The information in this document is subject to change without notice and should not be construed as a commitment by the manufacturing or selling entity, or an affiliate. We assume no responsibility for any errors that may appear in this document.Technical AssistanceVisit the tech service page at /techservice .Terms and Conditions of SaleWarranty, use restrictions, and other conditions of sale may be found at /terms .Contact InformationFor the location of the office nearest you, go to /offices .。

产品中残留溶剂控制申明模板(国外审计)说课讲解

产品中残留溶剂控制申明模板(国外审计)
Statement of Residual solvents for产品名称/简称
For “对方企业名称（英文）”
Name of the material:化学名称
，short name:有产品名简称时适用（与出厂标签上一致）
Following are the solvents used in the manufacturing process of +化学名称/简称
ClassⅠResidual Solvents:
♦一类溶剂的名称/
♦如未用到一类溶剂的填N/A
ClassⅡResidual Solvents:
♦二类溶剂的名称/
♦如未用到二类溶剂的填N/A
Class ⅢResidual Solvents:
♦三类溶剂的名称/
♦如未用到三类溶剂的填N/A
Other Residual Solvents:
♦除了上述三类溶剂之外的溶剂名称
Other than above mentioned none of the residual solvents are used.
We confirm that,if tested the “产品名称/简称” will comply with the standards of current USP and supplements for Residual Solvents<467>.
QA经理或质量负责人签字/日期
Mr./Mrs.xxxx,(上述签字人员名字拼音)
职务，Quality Assurance
“自己企业名称（英文)”。

【行业资料】微生物偏差调查及实例介绍

MDD调查组织
组织
QA
参与
其他部门
14
调查
MDD调查过程
15
调查
调查内容
1
2
仪器/设备
环境
3
微生物种类
4 培养基
• 是否在校验/ 计量有效期
• 是否定期清洁
• 是否得到正确使用
• 使用同一仪器的其他试验是否出现问题
• 是否定期进行环境
• 是否环境监控趋势异常。
未知微生物进行鉴别，推断其可能的出处，辅助确定MDD原因。
调查
调查关闭过程必须是正式的。第二阶段调查：
调查关闭
19
实例
简介
调查
实例
注意事项
20
实例
7月份，某中试车间制剂生产区域出现霉菌。
组织MDD
QA 2
1
启动MDD
QC
3
调查MDD
1、QC 2、QA 3、生产部门
霉菌MDD调查
21
实例
霉菌MDD调查第一阶段
人员
是否具备操作资质
培养基
是否在有效期内，是否完成确效实验，确效实验是否合格。
述。
温湿度：清洁人员因无程序指导且经验不足，对特殊表面清
洁可能未进行彻底清洁消毒。
36
实例
霉菌MDD调查第二阶段
结论与CAPA
1、结论
可能原因：相关清洁消毒人员对此门把手进行清洁消毒时，可能对其未进行彻底消毒清洁；清洁消毒SOP描述不全面，未涉及门把手等特殊部位清洁消毒程序。
2、CAPA
1、对清洁消毒SOP进行升级，加入相关部位清洁消毒流程描述 2、对清洁消毒人员依据升级后SOP进行培训。

生物样本分析

•流动相 (样品导入溶液) ：100mM 醋酸钠缓冲液 <pH=4.7>
样品导入溶液对回收率的影响 1
•样品导入溶液 pH值变化对回收率的影响
Table. 血浆样品中药物回收率 (spiked 2ug/mL each, 50uLinj.)
样品导入溶液对回收率的影响 2
•样品导入溶液离子强度变化对回收率的影响
• 使用新型色谱柱的自动浓缩系统实现了高灵敏度 • Co-Sense for BA + LCMS系统的特长
背景

样品前处理是目前分析化学的瓶颈，是分析化学研究的难点和热点问题之一。由于样品数量极多，且分析物含量越来越低、基体越来越复杂，迫切要求发展高通量、高选择性、高效率的
在线样品前处理技术。因此，开展这方面的研究具有极为重要
Table 血浆样品中各药物回收率结果 (spiked 0.5ug/mL each (Naproxen:2ug/mL), 50uLinj.)
10mM ammonium acetate 100mM ammonium acetate 200mM ammonium acetate Naproxen Lidocaine Noscapine Chlorpheniramine Propranolol Diphenhydramine Verapamil Acetohexamide Imipramine 100%< 96% 80% 87% 93% 80% 62% 78% 75% 99% 94% 99% 91% 96% 90% 100%< 80% 85% -
的意义。
HPLC/LC-MS广泛应用于血浆或血清的代谢物分析和原药分析，一般的血浆和血清分析，需要对样本进行预处理，以除去蛋白质，这样会降低精确度和工作效率。引入了具有限制性通路媒介（restricted access media -RAM）的预柱，可对血浆样本进行直接分析，而不必进行预处理。这样，可提高精确度、简化操作和提高工作效率。但是，使用限制性通路媒介柱，也存在一些问题，需解决的问题：回收率、灵敏度、耐用性。

SOLAAR032软件手册

UNICAM原子吸收光谱仪SOLAAR32 UNICAM 原子吸收 SOLLAAR32 软件常规手册目录1.引言1.1视窗Windows 951.2视窗Windows 95 帮助文件1.2.1显示视窗Windows 95 帮助信息2.SOLLAAR32程序的安装2.1软件的保护2.2原子光谱仪所用的软件2.3 GFTV(石罴炉进样监控系统)软件2.4软件的安装2.4.1SOLLAR32 数据库软件2.4.2安装升级的SOLAAR32 AutoQC(自动质量控制)软件2.4.3安装GFTV软件和接口组件2.5 SOLLAR 原子吸收组2.5.1阅读Read Me 信息(系统程序的介绍)2.6SOLLAAR32程序的删除2.7SOLLAAR32程序及打印机2.8SOLLAAR32应用程序的启动2.8.1SOLLAAR32的启动2.8.2为SOLLAAR32建立启动菜单快捷键2.8.3为SOLLAAR32建立桌面快捷键2.8.4用视窗Windows 95自动启动SOLLAAR322.9连接SOLAAR32程序3.SOLAAR32软件3.1概述3.1.1方法3.1.2步骤3.1.3样品的说明3.1.4结果3.1.5软件的安全保密性3.2 SOLAAR32的使用3.2.1 SOLAAR32状态窗口3.2.2 SOLAAR32特性页面3.2.3 SOLAAR32对话框3.2.4 SOLAAR32菜单1UNICAM原子吸收光谱仪SOLAAR322 3.2.5 SOLAAR32工具栏3.3.5 SOLAAR32状态栏3.3在线帮助3.3.1 主题3.3.2 学会使用在线帮助系统3.3.3 显示SOLAAR32帮助主题:对话内容表3.3.4 为对话框或特性页快速显示特定文本帮助3.3.5 为状态窗口快速显示特定文本帮助3.3.6为数据输入字段快速显示特定文本帮助4.开始4.1一次简单的火焰分析过程4.1.1开始前的工作4.1.2建立方法4.1.3设定分析顺序4.1.4建立分析样品的详细资料4.1.5安装空心阴极灯4.1.6校准空心阴极灯4.1.7点火,调整燃烧头和雾化器撞击球位置4.1.8进行分析4.1.9审查结果4.1.10打印结果4.2一次简单的石墨炉分析过程4.2.1开始前的工作4.2.2建立方法4.2.3设定分析顺序和样品的详细资料4.2.4安装和校准空心阴极灯4.2.5安装和校准空石墨炉4.2.6调整石墨炉自动进样器4.2.7点火,调整燃烧头位置和雾化器撞击球4.2.8进行分析4.2.9审查并打印结果4.3一次简单的气体分析过程4.3.1开始前的工作4.3.2建立方法4.3.3设定分析顺序和样品的详细资料4.3.4安装和校准空心阴极灯UNICAM原子吸收光谱仪SOLAAR323 4.3.5安装SOLAAR VP90 连续气体流动系统4.3.6安装SOLAAR EC90 电热原子吸收池附件4.3.7准直SOLAAR VP90 原子吸收池4.3.8准直SOLAAR VP90 载气流量，稳定化时间及基线延迟参数4.3.9点火4.3.10没定SOLAAR EC90 石墨炉温度参数4.3.11进行分析4.3.12审查并打印结果5.用户测试软件5.1概述5.2用户检测5.2.1光度计/数据站之间通讯的检测5.2.2光度计/自动进样器之间通讯的检测5.2.3光度计/石墨炉之间通讯的检测5.2.4气体箱泄漏的检测5.2.5光度计模拟电路的检测5.2.6光度计软件版本号的检测5.2.7光度计设置的检测5.2.8新氘(D2)灯5.2.9读数传感器的检测5.3 SOLAAR32 客户检测软件的使用5.3.1客户检测菜单5.3.2客户检测工具条5.3.3操作指导信息窗口5.3.4检测窗口5.3.5在开始之前5.3.6启动客户检测软件5.3.7进行测试5.3.8测试结果6 本系列仪器的异同1 引言祝贺您购卖Unicam SOLAAR 原子吸收光谱仪和SOLAAR32软件.我们竭尽全力为您提供一台功能强大,易于使用的光谱仪. 满足您进行元素分析的所有需求,我们衷心希望您对您的仪器操作及尽快地熟悉起来.UNICAM原子吸收光谱仪SOLAAR32此手册要为您提供SOLAAR32数据工作站软件的安装,使用的指导.本软件应与仪器所配的SOLAAR 用户手册一起使用,特别是:. 硬件手册 - 该手册叙述了光谱仪及其附件的使用和各项功能.. 分析方法手册- 该手册叙述了原子吸收光谱技术的物理和化学原理.同时就样品制备和相关的课题给予实际的指导.. SOLAAR32 在线帮助系统 - 此系统为该软件提供了详细使用说明,而且还包括在线“菜谱”,并给出了所有可用原子吸收光谱测定元素的基本参数.这将在下面的3.3节中进行详细的说明.对SOLAAR969系统也可用Local Controller 而不是Data Station进行设定. Local Controller 软件的使用将在该光谱仪操作手册中予以说明,在此不予讨论.1.1视窗Windows95您的SOLAAR32数据处理工作站软件是在Windows95系统下工作的.该软件是具有强大图形功能新一代帮助操作的系统,它的设计最大限度发挥现代微处理器功能和速度.它可在工作中为您提供许多有用和方便在使用solaar32应用程序之前，你应熟悉和会使用计算机及操作系统。

刨花检测报告样式

见下页
样品来源(Samp1eSource)
送样
所用主要仪器(MainInstruments)
气相色谱仪、原子吸收光谱仪等
备注(Note)
限值标准：DB11/T1126-2014该报告中检测方法由委托单位指定。
编制人(Editedby)
审核人
(Checkedby)
批准人
(Approvedby)
签发日期(IssuedDate)
未检出(<0.1)
符合
GB/T13080-20187.2
3
镉
mg/kg
≤0.2
未检出(<0.20)符合GB/T13082-2023
4
汞
mg/kg
≤O.02
未检出(<0.00015)
符合
GB/T13081-20064
5
八/、八
mg/kg
≤0.3
未检出(<0,0008)
符合
GB/T13090-2006
6
—
检测日期(TestDate)
样品等级(Samp1eGrade)
—
样品数量(Samp1eQuantity)
1150g
检测类别(TestType)
委托检测
样品状态(Samp1eStatus)
包装完好，固体正常
检测环境(TestEnvironment)
符合要求
检测项目(TestItems)
见下页
检测方法(TestMethods)
检测结果(TeStResu1ts)：
序号(S/N)
检测项目(TestItems)
单位(Unit)
限值(1imit)
检测结果(TestResu1ts)

对不合格试验结果(out of specificationoos)进行调查

96.3
86.4
91.9
How does RSD compare with previous?
83.0
88.4
92.5
Is this atypical, never stated
5.4 OOS result
OOS Subteam
看数据时, 要全面看
5.8000 5.6000 5.4000 5.2000 5.0000 4.8000 4.6000 4.4000 4.2000
确认实验室错误?
完成复测计划
确认实验室错误?
Y es
Y es
reanalysis? Y es 正常水平retest
No
No
No 进入 St age 3
符合标准
No
进入 St age 4
Y es 报告结果
实验室调查完成确定根
本原因
` 实验室错误举例 ◦ 移液管 ◦ 容量瓶 ◦ 标准品、标准称量、纯度系数 ◦ 样品称量 ◦ 混样 ◦ HPLC/GC 色谱柱 ◦ HPLC 进样针弯
同时进行
◦ 对生产的扩大调查按照偏差调查进行 ◦ 目的是找出OOS的根本原因
Stage 4 Start
确定根本原因
Yes
确定CAPA
No
进行根本原因调查
Stage 5; 总结摘要
总结调查报告
No
QA经理批准
实验室错误
Yes
实验室经理批准
报告结果
End
` People ` Equipment ` Method ` Materials ` Environment
` The sample remained at 1200°C for only 30 minutes. The XXXX content is 0.05%, specification is NMT 0.025%. The testing was for batch release purposes, and was carried out by Fred Bloggs.

国际贸易实务英文名词解释(英to英)

国际贸易实务英文名词解释（英to英)What's International Trade?The international trade is the exchange of goods and services produced in one country for goods and services producedin another country。

EXPORTINGExporting is the process of earning money by providing the right product at the right price at the right time in the right place beyond your home boundary。

The ultimate goal is to make sure that the exporter is to be paid for the goods he sells。

EXWEXW means the seller delivers when he places the goods at the disposal of the buyer at the seller's premises (法定地址）or another named place。

The seller doesn’t not declare the goods for export and he needn’t load goods on any collecting vehicle。

FASFree alongside ship means that the seller delivers when the goods are placed alongside the vessel at named port of shipment. This means that the buyer has to bear all costs and risks of the goods from that moment。

中英文不合格处置单

(WD-QP-QD-017-01）
不合格处置单
Nonconformity disposal
序号：减速机型号
Gearbox Type
零件名称和型号
Item Name/Type
发现者
Discoverer
订单号
order No.
零件图号
Dwg
发现日期
Date 责任单位（责任者） Accountability unit
负责人或参与人
stewards or porticioants
最终判定：
Finnal decision:
接收部门/人员(签字）：
Accept department：
不合格原因调查分析：
Investigation of the reasons for failure
填写说明： 1、判定结果：检验人员给出判定结果，让步接收/试装须质量经理签字； 2、检验人员无法判定，由质量经理判定。质量经理不确定判定结果，由生产运营部副总经理召集各专业进行判定。在“处置过程记录”项分别给出各自意见并签字，形成最终结论。第三联生产计划及库管科
检验组长（签字）：
Inspection team leader:
质量科经理（签字）：
QA manager:
处置过程记录:
Disposal of records 技术/Technology 装配科/Assenbly section 机加工科/Machine engineering 质量科/Quality department
工作令号
Work No. 不合格事实描述(发现者填写): Substandard factuaQty
检验员（签字）：
Checker sign:

生物安全三级实验室生物安全风险点的识别与控制

39２０１９年第３６卷第３期生物安全三级实验室生物安全风险点的识别与控制�王团结1，姚文生1，康　凯1，万建青1，王利永1，李　阳2，赵俊杰1（1.中国兽医药品监察所，北京　100081；2.中国动物卫生与流行病学中心，青岛　266032）摘　要：BSL-3实验室须经国家生物安全认可和严格的实验活动审批才能开展相应活动，是国家（地区）开展高致病性病原微生物实验活动的重要技术支撑平台。

实验室生物安全风险点易发生在样本及菌毒种的接收、传递和保存，动物实验，污水以及固体废弃物处理等环节，而实验室的意外事件（电力故障、火灾、积水等）与生物安保漏洞也会造成重大的生物安全事故。

提示应准确地识别风险并通过人员日常监管、标准操作规程、两级屏障设施和个人防护装备等系列措施对生物安全风险点予以严格控制。

关键词：生物安全三级实验室；样本和菌毒种；动物实验；意外事件；风险识别；风险控制中图分类号：S 851.3 文献标识码：A 文章编号：1005-944X （2019）03-0039-04DOI ：10.3969/j.issn.1005-944X.2019.03.008Identification and Control of Risk Points in Bio-safety Level 3 LaboratoriesWang Tuanjie 1，Yao Wensheng 1，Kang Kai 1，Wan Jianqing 1，Wang Liyong 1，Li Yang 2，Zhao Junjie 1（1. China Institute of Veterinary Drug Control ，Beijing 100081，China ；2.China Animal Health and Epidemiology Center ，Qingdao ，Shandong 266032，China ）Abstract ：As an important technical support platform for the national （regional ）activities related to highly pathogenic microorganisms ，bio-safety level 3 laboratories （BSL-3 laboratories ）must carry out such activities subject to the accreditation of bio-safety and rigorous approval by the state. Bio-safety risk points would be likely to appear in the processes consisting of receiving ，transferring and preserving samples and bacterial & viral strains ，animal experiments ，disposal of sewage and solid waste ，while major bio-safety accidents may also be caused by contingency （power failure ，ﬁre ，water accumulation ，etc.）and bio-security leaks. Therefore ，it was suggested that risks should be identiﬁed accurately and bio-safety risk points should be strictly controlled through a series of measures ，including strengthening daily supervision by personnel ，standardizing operating procedures ，setting two-level barrier facilities and improving personal protective equipment.Key words ：BSL-3 laboratories ；samples and bacterial & viral strains ；animal experiment ；accidents ；risk identiﬁcation ；risk control生物安全三级（BSL-3）实验室或动物生物安全三级（ABSL-3）实验室开展实验活动的重要前提是保证实验人员安全和周围环境安全。

PICS PE009-10(Annexes) 20130101 药品GMP指南附件目录(中英文)

PIC/S PE009-10(Annexes) 20130101 药品GMP指南附件目录（中英文）PHARMACEUTICAL INSPECTION CONVENTIONPHARMACEUTICAL INSPECTION CO-OPERATION SCHEMEPE 009-10 (Annexes)1 January 2013GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINALPRODUCTS药品GMP指南ANNEXES附件ANNEXES 附件目录Annex 1Manufacture of sterile medicinal products无菌药品生产Annex 2Manufacture of biological medicinal products for human use 人用生物制品生产Annex 3Manufacture of radiopharmaceuticals辐射药品生产Annex 4Manufacture of veterinary medicinal products other than immunologicals 非疫苗类兽药生产Annex 5Manufacture of immunological veterinary medical products 疫苗类兽药生产Annex 6Manufacture of medicinal gases药用气体生产Annex 7Manufacture of herbal medicinal products中药产品生产Annex 8Sampling of starting and packaging materials起始物料和包材取样Annex 9Manufacture of liquids, creams and ointments液体、乳膏和软膏剂生产Annex 10Manufacture of pressurised metered dose aerosol preparations for inhalation吸入剂压力计量气体制剂生产Annex 11Computerised systems计算机系统Annex 12Use of ionising radiation in the manufacture of medicinal products 药品生产中离子化辐射的应用Annex 13Manufacture of investigational medicinal临床试验用药品生产Annex 14Manufacture of products derived from human blood or human plasma 人体血液和血浆制品生产Annex 15Qualification and validation确认和验证Annex 16[Qualified person and batch release]*授权人和批放行Annex 17Parametric release参数放行Annex 18[GMP Guide for active pharmaceutical ingredients]**原料药GMP指南Annex 19Reference and Retention Samples对照品和留样* This Annex is specific to the EU GMP Guide and has not been adopted by PIC/S.该附件仅应用于EU GMP指南，未被PIC/S采用。

羊毛角蛋白的溶解机制研究

羊毛作为一种天然蛋白质资源,在国际上被认为是一种具有潜在价值的蛋白质,其蛋白含量高达99%[1].羊毛产业的废弃物、旧衣料品等每年大量产生[2],仅其中一部分被重复利用,大部分废弃物被焚烧处理或填埋处理,这不仅污染了环境,更主要的是浪费了大量的蛋白质资源[3].因此,为了减轻环境负担,发展可持续性开发利用,研究羊毛角蛋白的提取方法和应用价值是目前亟待解决的问题.羊毛角蛋白的提取溶解是其再利用的至关重要的步骤,它对羊毛角蛋白的性能及其应用具有显著的影响[4].然而,大分子羊毛角蛋白内的二硫键使肽链内部和肽链之间发生交联,形成立体网状结构,使之难以溶解[5],这给羊毛角蛋白的提取造成极大地困难.目前羊毛角蛋白的提取方法主要有酸碱法[6]、还原法[7]、酶法[8]、离子液体法[9]等,这些方法不仅需要大量的化学试剂造成环境污染,而且成本高、周期长、效率低.因此,开发新型的羊毛角蛋白提取技术是行之有效的方法之一,为实现高效、经济、环保的目标奠定基础[10].棚桥光彦等开发了新型的羊毛角蛋白的提取方法-熔融尿素溶解法[11].本方法只使用尿素和乙醇,而尿素的熔融温度低,安全可靠,成本低,适合于大量生产,且尿素与乙醇可以回收循环利用.另外需要的时间短,尿素和羊毛角蛋白的分离过程简便,分离的蛋白质可以直接当作有机肥料或饲料等产品.经过实验已经确认羊毛在熔融尿素中可完全溶解,但具体的溶解机制尚不明确.因此,本文使用标准化合物替代角蛋白中的主要氨基酸、肽键及化学键与熔融尿素进行化学反应,使用GC-MS 分析反应产物及二硫键及肽键的断裂状况,旨在探究熔融尿素法提取羊毛角蛋白的溶解机制.1实验材料和方法1.1材料、试剂及仪器设备材料:羊毛日本毛绒株式会社.试剂:尿素、乙酸乙酯、氯化钠、硫酸钠、丙酮,化学试剂均为分析纯.标准化合物:谷氨酸、胱氨酸、精氨酸、丝氨酸、亮氨酸、甘氨酸、甘氨酰甘氨酸、甘氨酰亮氨酸和甘氨酰甘氨酰甘氨酸.仪器设备:高温油浴锅、日本岛津气相色谱质谱联用仪(GC-MS)-QP5050A.1.2实验方法Vol.35No.9Sep.2019赤峰学院学报（自然科学版）JournalofChifengUniversity （NaturalScienceEdition ）第35卷第9期2019年9月收稿日期:2019-06-21基金项目:内蒙古自治区高等学校科学研究项目(NJZY17307);赤峰学院服务地方项目(CFXYFD201812)羊毛角蛋白的溶解机制研究萨如拉1,春花2,刘鑫岩1,谭颖慧1,尹利国1,宫川剛3,棚桥光彦3(1.赤峰学院化学与生命科学学院,内蒙古赤峰024000;2.内蒙古谱尼测试技术有限公司,内蒙古呼和浩特010000;3.日本岐阜大学应用生命科学部,日本岐阜501-1193)摘要:以羊毛为原料,采用熔融尿素法溶解羊毛分析其溶解机制.分别使用谷氨酸、胱氨酸、精氨酸、丝氨酸、亮氨酸、甘氨酸、甘氨酰甘氨酸、甘氨酰亮氨酸、甘氨酰甘氨酰甘氨酸等标准化合物替代羊毛角蛋白中主要的氨基酸、肽键及化学键,与150℃熔融尿素反应20min ,经乙酸乙酯分液3次,有机层脱水浓缩,丙酮溶解,GC-MS 分析,检测其反应产物及化学键的变化.结果表明:在使用不同标准化合物与熔融尿素反应中发现,仅胱氨酸、亮氨酸和甘氨酰-L-亮氨酸与尿素发生化学反应,部分二硫键及肽键发生断裂,其余标准化合物与尿素未发生化学反应.综上可知,在溶解条件为150℃20min 时,尿素仅切断羊毛角蛋白中少量二硫键或肽键,使得羊毛角蛋白仍保持较高的分子量.关键词:熔融尿素法;羊毛;溶解机制;角蛋白中图分类号：TS102.311文献标识码：A文章编号：1673-260X （2019）09-0030-0330--1.2.1标准化合物的选择为了分析熔融尿素溶解羊毛的反应机理,分别选用谷氨酸、胱氨酸、精氨酸、丝氨酸、亮氨酸、甘氨酸、甘氨酰甘氨酸、甘氨酰亮氨酸、甘氨酰甘氨酰甘氨酸等标准化合物来替代羊毛角蛋白中的主要氨基酸、肽键及化学键与尿素进行化学反应.1.2.2尿素与标准化合物的化学反应于干燥试管中加入2g 尿素,在150℃油浴锅中加热至尿素熔融,再加入0.2g 标准化合物,150℃反应20min,取出试管加入8mL 的蒸馏水,冷却至室温,加入乙酸乙酯10mL,进行3次分液.有机层由20mL 的食盐水脱水一次,再使用硫酸钠脱水,过滤除去硫酸钠,浓缩,加入丙酮(c=g/L)溶解,进行GC-MS 分析.GC-MS 分析条件如下:进样温度230℃,气化室温度300℃,初始温度为100℃,保持5min,以10℃/min 速率上升至300℃,保持5min,分析时间为30min [12].测定仪器为GCMS-QP5050A;电离模式:EI(电子电离);电压:70eV;毛细管柱:DB-5MS(J&W Sci⁃entific)、0.25mm(I.D.)×30m(L)×0.5μm;载气:He;测定方法:扫描.2结果与分析2.1尿素与胱氨酸反应尿素与胱氨酸反应产物的有机层GC-MS 色谱分析结果及峰对应化合物的结构如图1.胱氨酸与尿素反应后保留时间11min 到15min 之间出现了3种与环化尿素结合的胱氨酸化合物.3种化合物的区别在于是否含有二硫键,11min 时出现的化合物的二硫键已经断裂,15min 时出现的化合物仍然含有二硫键.本实验中尿素与胱氨酸反应产物的有机层回收量比较少,不能确定上述产生3中化合物的反应途径为主要的反应途径,但可以得到尿素切断二硫键的结果.2.2尿素与亮氨酸反应尿素与亮氨酸反应产物的有机层GC-MS 色谱分析结果及峰对应化合物的结构如图2.亮氨酸与尿素的反应也与胱氨酸反应一样,在保留时间15min 的时候出现与环化尿素结合的亮氨酸化合物的峰.2.3尿素与甘氨酰-L-亮氨酸反应甘氨酰-L-亮氨酸与尿素反应产物的有机层GC-MS 色谱分析结果及峰对应化合物的结构如图3.在保留时间15min 时候出现了与环化尿素结合的亮氨酸化合物峰,本实验也与胱氨酸反应同样,甘氨酰-L-亮氨酸与尿素反应产物有机层的回收量比较少,有可能尿素与甘氨酰-L-亮氨酸反应积极性不是很大,但与环化尿素结合的不是二肽而是氨基酸,可以得出尿素切断肽键的结果.2.4尿素与其他氨基酸及肽的反应尿素与谷氨酸、精氨酸、丝氨酸、甘氨酸、甘氨酰甘氨酸、甘氨酰甘氨酰甘氨酸的反应产物的有机层中未发现尿素的反应产物.尿素与谷氨酸、精氨酸、丝氨酸、甘氨酸有可能不产生化学反应,不切断甘氨酰甘氨酸、甘氨酰甘氨酰甘氨酸的肽键.3结论与讨论本文研究了羊毛在熔融尿素中的溶解机制.在使用标准化合物与熔融尿素的反应中,仅亮氨酸、图1尿素与胱氨酸反应产物的有机层GC-MS 色谱分析结果及峰对应化合物的结构图2尿素与亮氨酸反应产物有机层的GC-MS 色谱分析结果及峰对应化合物的结构图3尿素与甘氨酰-L-亮氨酸反应产物有机层的GC-MS 色谱分析结果及峰对应化合物的结构31--胱氨酸、甘氨酰-L-亮氨酸与尿素发生化学反应,部分二硫键及肽键发生断裂,其余标准化合物谷氨酸、精氨酸、丝氨酸、甘氨酸、甘氨酰甘氨酸、甘氨酰甘氨酰甘氨酸与尿素未发生化学反应.可知,在溶解条件为150℃20min时,尿素仅切断羊毛角蛋白中少量二硫键或肽键,使得羊毛角蛋白仍保持较高的分子量.这与Murate[14]等的十二烷基苯磺酸钠-聚丙烯酰胺凝胶电泳(SDS-PAGE)测定溶解羊毛角蛋白分子量的实验结果一致.为了更详细了解羊毛在熔融尿素中的溶解机制,分析20种氨基酸与尿素的反应是下一步需要研究的课题.随着纤维产业的废弃物、破旧的衣料等蛋白纤维日益增加,如何利用废物纤维蛋白质已成为一个重要的课题,熔融尿素法可以从废弃的蛋白质纤维中大量提取蛋白质,为纤维蛋白的有效利用(比如加工成蛋白质饲料或有机氮肥料等产品)提供了参考.———————————————————参考文献院〔1〕Wang J B,Liu J Y,Wang J,et al.The Ef⁃ficient Wool Keratin Dssolution Based on New Reductant[J].Advanced Materials Research, 2012,441:656-660.〔2〕房启海,朱平,董朝红等.熔融尿素法提取羊毛角蛋白工艺研究[J].青岛大学学报,2016,31(2): 71-75.〔3〕Zhao W,Yang R J,Zhang Y Q,et al.Sus⁃tainable and Practical Utilization of Feather Keratin by an Innovative Physicochemical Pre⁃treatment:High Density Steam Flash-Explosion [J].Green Chemistry,2012,14(12):3352-3360.〔4〕贾济如,姚金波.废弃羊毛角蛋白循环利用研究的最新进展[J].毛纺科技,2015,43(1):45-49.〔5〕李鹏飞,洪颖,陈双春,等.角蛋白的提取及其生物医学应用[J].高分子通报,2013(6):7-11.〔6〕Toran-Diaz I,Jain V K,Allais J J,et al.Ef⁃fect of Acid or Enzymatic Hydrolysis on Ethanol Production by Zymomonas Mobilis Growing on Jerusalem Artichoke Juice[J].Biotechnology Letters,1985,7(7):527-530.〔7〕徐恒星,史吉华,周奥佳,等.羊毛角蛋白的提取及其成膜性[J].纺织学报,2010,33(6):41-47.〔8〕Eslahi N,Dadashian F,Nejad N H.Optimiza⁃tion of Enzymatic Hydrolysis of Wool Fiber for Nanoparticles Production Using Response Surface Methodology[J].Advanced Powder Technology,2013,24(24):416-426.〔9〕Li R,Wang D.Preparation of Regenerated Wool Keratin Films from Wool Keratin-Ionic Liquid Solution[J].Journal of Applied Polymer Science,2013,127(4):2648-2653.〔10〕王丽静,史吉华,周奥佳,等.新型羊毛角蛋白提取技术探究[J].毛纺科技,2013,41(5):1-6.〔11〕Tanahashi M,Murate H.Method of Classify⁃ing Proteins,Method of Dissolving Proteins, Method of Fractionating and Collecting Nonanimal Fiber and Proteins Originating in Animal Fiber:WOPatent,119596A1[P],2009.〔12〕萨如拉,陈建兴,春花等.高压水蒸气蒸馏法提取和厚朴树枝有效精油成分[J].河南农业科学,2017,46(5):152-156.〔13〕山内清.ケラチンの化学と利用-現在の課題[J].高分子,2001,50(4):241-243.〔14〕Murate H,Shigematsu M,Abe K,et al.Molten urea as a novel dissolving solvent for wool and other animal proteins[J].Fiber, 2010,66(6):156-159.32--。

埃里科白板修复剂安全数据表说明书

SAFETY DATA SHEETLYRECO WHITEBOARD RENOVATORProduct name LYRECO WHITEBOARD RENOVATORProduct number978,598Internal identification AWBR150LYR1.2. Relevant identified uses of the substance or mixture and uses advised againstIdentified uses Cleaning ProductUses advised against At this moment in time we do not have information on use restrictions. They will be included inthis safety data sheet when availableSupplier LYRECORue du 19 mars 1962, F-59770MARLYFRANCE+33 (0) 3 27 23 64 001.4. Emergency telephone numberEmergency telephone+33 (0) 3 27 23 64 00Physical hazards Aerosol 3 - H229Health hazards Acute Tox. 4 - H332Environmental hazards Not ClassifiedHuman health Contact with liquefied gas might cause frostbites, in some cases with tissue damage.PictogramSignal word WarningHazard statements H229 Pressurised container: may burst if heatedH332 Harmful if inhaled.Precautionary statements P102 Keep out of reach of children.P251 Do not pierce or burn, even after use.P261 Avoid breathing vapour/spray.P271 Use only outdoors or in a well-ventilated area.P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.P312 Call a POISON CENTER/doctor if you feel unwell.P410+P412 Protect from sunlight. Do not expose to temperatures exceeding 50°C/122°F. Contains2-BUTOXYETHANOL, DISODIUM METASILICATE3.2. MixturesThe Full Text for all R-Phrases and Hazard Statements are Displayed in Section 16.Composition comments Ingredients not listed are classified as non-hazardous or at a concentration below reportablelevels.,Ingredients are registered on AICSInhalation Move affected person to fresh air at once. Keep affected person warm and at rest. Getmedical attention immediately.Ingestion Do not induce vomiting. Rinse mouth thoroughly with water.Skin contact Wash skin thoroughly with soap and water. Get medical attention if any discomfort continues.Eye contact Remove any contact lenses and open eyelids wide apart. Continue to rinse for at least 15minutes and get medical attention.4.2. Most important symptoms and effects, both acute and delayedNotes for the doctorTreat symptomatically.The product is not flammable. Use fire-extinguishing media suitable for the surrounding fire.Suitable extinguishing mediaSpecific hazards Vapours are heavier than air and may travel along the floor and accumulate in the bottom ofcontainers. Vapours may be ignited by a spark, a hot surface or an ember. Containers canburst violently or explode when heated, due to excessive pressure build-up.Hazardous combustion products Oxides of carbon. Thermal decomposition or combustion may liberate carbon oxides and other toxic gases or vapours.Protective actions duringfirefightingMove containers from fire area if it can be done without risk.Special protective equipment for firefighters Wear positive-pressure self-contained breathing apparatus (SCBA) and appropriate protective clothing.Personal precautions Avoid inhalation of vapours and contact with skin and eyes.6.2. Environmental precautionsEnvironmental precautions Do not discharge into drains or watercourses or onto the ground.6.3. Methods and material for containment and cleaning upMethods for cleaning up Absorb in vermiculite, dry sand or earth and place into containers.Reference to other sections Wear protective clothing as described in Section 8 of this safety data sheet. See Section 11for additional information on health hazards. Collect and dispose of spillage as indicated inSection 13.7.1. Precautions for safe handlingUsage precautions Provide adequate ventilation. Avoid inhalation of vapours. Use approved respirator if aircontamination is above an acceptable level.Storage precautions Store at moderate temperatures in dry, well ventilated area.Specific end use(s)The identified uses for this product are detailed in Section 1.2.2-BUTOXYETHANOLLong-term exposure limit (8-hour TWA): WEL 25 ppm 123 mg/m³Short-term exposure limit (15-minute): WEL 50 ppm 246 mg/m³SkMORPHOLINELong-term exposure limit (8-hour TWA): WEL 10 ppm 36 mg/m³Short-term exposure limit (15-minute): WEL 20 ppm 72 mg/m³SkWEL = Workplace Exposure LimitSk = Can be absorbed through the skin.Appropriate engineering controls Provide adequate general and local exhaust ventilation. Observe any occupational exposure limits for the product or ingredients.Eye/face protection The following protection should be worn: Chemical splash goggles. EN166Hand protection Chemical-resistant, impervious gloves complying with an approved standard should be worn ifa risk assessment indicates skin contact is possible. It is recommended that gloves are madeof the following material: Nitrile rubber. Gloves should conform to EN374Other skin and body protection Wear appropriate clothing to prevent any possibility of liquid contact and repeated or prolonged vapour contact.Hygiene measures Use engineering controls to reduce air contamination to permissible exposure level. Provideeyewash station. Wash hands at the end of each work shift and before eating, smoking andusing the toilet. Use appropriate skin cream to prevent drying of skin. When using do not eat,drink or smoke. Do not smoke in work area.Respiratory protection If ventilation is inadequate, suitable respiratory protection must be worn. EN14387Appearance Aerosol. Liquid.Colour Colourless.Odour Characteristic.pH pH (concentrated solution): 7 - 8Initial boiling point and range>100°C @Vapour pressure@ °CRelative density0.995 @ @ 20°CSolubility(ies)Soluble in water.Auto-ignition temperature> 750°C9.2. Other informationReactivity There are no known reactivity hazards associated with this product.Stability Stable at normal ambient temperatures and when used as recommended.Possibility of hazardousreactionsNot available. Will not polymerise.10.4. Conditions to avoidConditions to avoid Avoid heat, flames and other sources of ignition. Avoid contact with acids and alkalis.10.5. Incompatible materialsMaterials to avoid No specific material or group of materials is likely to react with the product to produce ahazardous situation.Hazardous decomposition products Thermal decomposition or combustion products may include the following substances: Carbon monoxide (CO). Hydrogen fluoride (HF). Carbonyl fluoride11.1. Information on toxicological effectsOther health effects There is no evidence that the product can cause cancer.ATE oral (mg/kg)153,803.87099502Acute toxicity - dermalATE dermal (mg/kg)96,898.20051233Acute toxicity - inhalationATE inhalation (vapours mg/l)66.06695489General information No specific health hazards known.Inhalation Gas or vapour in high concentrations may irritate the respiratory system. Symptoms followingoverexposure may include the following: Headache. Fatigue. Nausea, vomiting.Ecotoxicity Not regarded as dangerous for the environment.12.1. ToxicityPersistence and degradability There are no data on the degradability of this product.Bioaccumulative potential No data available on bioaccumulation.12.4. Mobility in soilMobility The product contains volatile organic compounds (VOCs) which will evaporate easily from allsurfaces.12.5. Results of PBT and vPvB assessmentResults of PBT and vPvBassessmentThis product does not contain any substances classified as PBT or vPvB.12.6. Other adverse effectsOther adverse effects Not available.General information Do not puncture or incinerate, even when empty.Disposal methods Empty containers must not be punctured or incinerated because of the risk of an explosion.Dispose of waste to licensed waste disposal site in accordance with the requirements of thelocal Waste Disposal Authority.General This product is packed in accordance with the Limited Quantity Provisions of CDGCPL2, ADRand IMDG. These provisions allow transport of aerosols of less than 1litre packed in cartonsof less than 30kg gross to be exempt from control providing that they are labelled inaccordance with the requirements of these regulations to show that they are being transportedas Limited Quantities. Aerosols not so packed must show the followingUN No. (ADR/RID)1950UN No. (IMDG)1950UN No. (ICAO)195014.2. UN proper shipping nameProper shipping nameAEROSOLS(ADR/RID)AEROSOLSProper shipping name(IMDG)Proper shipping name (ICAO)AEROSOLSProper shipping name (ADN)AEROSOLS14.3. Transport hazard class(es)ADR/RID class2ADR/RID subsidiary riskADR/RID label 2.2IMDG class 2.2IMDG subsidiary riskICAO class/division 2.2ICAO subsidiary riskTransport labelsADR/RID packing group N/AIMDG packing group N/AICAO packing group N/AEnvironmentally hazardous substance/marine pollutantNo.14.6. Special precautions for userEmS F-D, S-UEmergency Action CodeHazard Identification Number(ADR/RID)Tunnel restriction code(E)Transport in bulk according toNot applicable.Annex II of MARPOL 73/78and the IBC CodeNational regulations The Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (SI 2009No. 716).The Control of Substances Hazardous to Health Regulations 2002 (SI 2002 No. 2677) (asamended).Rivers (Prevention of Pollution) Act 1961.Control of Pollution (Special Waste) Regulations 1980 (as amended).EU legislation System of specific information relating to Dangerous Preparations. 2001/58/EC.Dangerous Preparations Directive 1999/45/EC.Dangerous Substances Directive 67/548/EEC.Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicativeoccupational exposure limit values in implementation of Council Directive 98/24/EC on theprotection of the health and safety of workers from the risks related to chemical agents atwork (as amended).Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18December 2006 concerning the Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH) (as amended).Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16December 2008 on classification, labelling and packaging of substances and mixtures (asamended).Guidance Workplace Exposure Limits EH40.Approved Classification and Labelling Guide (Sixth edition) L131.No specific authorisations are known for this product.Authorisations (Title VIIRegulation 1907/2006)No specific restrictions on use are known for this product.Restrictions (Title VIIIRegulation 1907/2006)15.2. Chemical safety assessmentRevision date06/07/2015Revision0SDS number21005Risk phrases in full NC Not classified.R11 Highly flammable.R20/21/22 Harmful by inhalation, in contact with skin and if swallowed.R22 Harmful if swallowed.R36 Irritating to eyes.R36/38 Irritating to eyes and skin.R38 Irritating to skin.R41 Risk of serious damage to eyes.R65 Harmful: may cause lung damage if swallowed.R67 Vapours may cause drowsiness and dizziness.Hazard statements in full H226 Flammable liquid and vapour.H229 Pressurised container: may burst if heatedH272 May intensify fire; oxidiser.H301 Toxic if swallowed.H302 Harmful if swallowed.H312 Harmful in contact with skin.H314 Causes severe skin burns and eye damage.H315 Causes skin irritation.H318 Causes serious eye damage.H319 Causes serious eye irritation.H330 Fatal if inhaled.H331 Toxic if inhaled.H332 Harmful if inhaled.H335 May cause respiratory irritation.H351 Suspected of causing cancer.H400 Very toxic to aquatic life.This information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process. Such information is, to the best of the company's knowledge and belief, accurate and reliable as of the date indicated. However, no warranty, guarantee or representation is made to its accuracy, reliability or completeness. It is the user's responsibility to satisfy himself as to the suitability of such information for his own particular use.。

关于食品安全抽检中合格备份样品处置的探讨

《中华人民共和国反食品浪费法》和《反食品浪费工作方案》分别在2021年4月和2021年11月正式发布实施，至此，防止食品浪费有法可依。

新版《食品安全抽样检验管理办法》于2019年10月开始实施，该办法第十七条中指出食品安全监督抽检中的样品分为检验样品和复检备份样品。

在实际工作中，除了保质期短的食品（比如餐饮食品、食用农产品、糕点等）、少数因无利用价值的不合格备份样品需要销毁处置外，大多数合格备份样品都会长时间贮存在承担抽检任务的检验检测机构的备样库，如果不进行科学合理的分配再利用，这些积压下来的合格备份样品就会造成很大的食品浪费。

本文结合部分地方市场监管部门制定的有关食品安全抽样合格备份样品的处置管理办法，归纳总结了一些合格备份样品的处置方式和注意事项，旨在为市场监管部门、食品承检机构对合格备份样品的处置工作提供参考。

1 合格备样处置中存在的问题对于食品检测机构，做好样品管理是贯穿整个检测工作的重要内容，也是检测过程中的必要环节和关键控制点[1]。

按照《食品安全监督抽检实施细则》中的分类，食品有33大类，如粮食加工品、肉制品、水果制品、餐饮食品、酒类等。

食品种类繁多，按不同状态可分为固体食品、液体食品、半固体食品；按是否有包装，可分为预包装食品和散装食品；按加工工艺不同，可分为生制品和熟制品[2]。

面对种类繁杂、作者简介：吴亮（1983—），男，本科，工程师，研究方向为食品检验检测。

通信作者：张波（1983—），男，本科，高级工程师，研究方向为食品药品检验检测。

E -mail：***************。

doi:10.16736/41-1434/ts.2023.8.045关于食品安全抽检中合格备份样品处置的探讨Discussion on the Disposal of Qualified Backup Samples in Food Safety Sampling Inspection◎ 吴亮，张波，刘杰，霍旭（承德市食品药品检验检测中心，河北承德 067101）WU Liang, ZHANG Bo, LIU Jie, HUO Xu(Chengde Food and Drug Inspection and Testing Center, Chengde 067101, China)摘要：反对食品浪费是市场监管部门和食品承检机构义不容辞的责任。