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480910 Ethanol 20%

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Ethanol 20% MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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480910
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4.80910.9010
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      		 Plastic container 10 l
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      4.80910.9025
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          		 Barrel PE/met 25 l
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          4.80910.9180
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              		 Barrel PE/met 180 l
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              Description
              Catalogue Number480910
              References
              Product Information
              HS Code2208 90 00
              Quality LevelMQ500
              Applications
              Biological Information
              Physicochemical Information
              Density0.9686 g/cm3
              pH value7.0 (10 g/l, H₂O, 20 °C)
              Dimensions
              Materials Information
              Toxicological Information
              Safety Information according to GHS
              Hazard Pictogram(s) Hazard Pictogram(s)
              Hazard Statement(s)H226: Flammable liquid and vapour.
              Precautionary Statement(s)P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
              P233: Keep container tightly closed.
              P240: Ground and bond container and receiving equipment.
              P241: Use explosion-proof electrical/ ventilating/ lighting equipment.
              P242: Use non-sparking tools.
              P243: Take action to prevent static discharges.
              Signal WordWarning
              Storage class3 Flammable liquids
              WGKWGK 1 slightly hazardous to water
              Disposal28
              Aqueous solutions: Container D.
              Safety Information
              Categories of dangerflammable
              Product Usage Statements
              Storage and Shipping Information
              StorageStore at +5°C to +30°C.
              Packaging Information
              Transport Information
              Declaration (railroad and road) ADR, RIDUN 1170 , 3, III
              Declaration (transport by air) IATA-DGRUN 1170 , 3, III
              Declaration (transport by sea) IMDG-CodeUN 1170 , 3, III
              Supplemental Information
              Specifications
              Assay (Ethanol)19.5 - 20.5 % (w/w)
              Evaporation residue≤ 10 mg/l
              Lotnumber (Ethanol)
              Bacterial endotoxins≤ 2.5 I.U./ml
                                                                                        Parameter with periodic testing
              ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
              Total aerobic microbial count (TAMC)                  ≤ 10¹                      CFU/ml
              Total combined yeasts/moulds count (TYMC)      ≤ 10¹                      CFU/ml
              Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities).
              Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
              Manufactured with Ethanol absolute (acc. to Ph Eur, BP, JP, USP) & purified water (acc. to Ph Eur).
              Filtered by 0.2 µm Filter.
              Global Trade Item Number
              Catalogue Number GTIN
              4.80910.9010 04027269213923
              4.80910.9025 04054839588341
              4.80910.9180 04027269197339

              Documentation

              Material Qualification Dossier

              TitleVersion
              10.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Ethanol 20% SDS

              Title

              Safety Data Sheet (SDS) 

              Ethanol 20% Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              4.80910.9010 Plastic containerPDF Specification Document
              4.80910.9025 Barrel PE/metPDF Specification Document
              4.80910.9180 Barrel PE/metPDF Specification Document

              Certificates

              Title

              Brochure

              Title
              GMPグレード Cleaning in Place (CIP) 用製品
              バイオ医薬品製造用製品ガイド