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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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      4.80910.9180
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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
          Density0.9704 g/cm3 (20 °C)
          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
          4.80910.9180 04027269197339

          Documentation

          Material Qualification Dossier

          TitleVersion
          8.0

          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
          4.80910.9180 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