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100971 Ethanol 96%

EMPROVE® EXPERT Ph Eur,BP,ChP

Ethanol 96% MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Ethyl alcohol, EtOH

CAS #: 64-17-5 EC Number: 200-578-6 Molar Mass: 46.07 g/mol Chemical Formula: C₂H₅OH Hill Formula: C₂H₆O Grade: Ph Eur,BP,ChP
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100971
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
64-17-5200-578-6C₂H₆OC₂H₅OH46.07 g/molPh Eur,BP,ChP

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      1.00971.2500
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          1.00971.9950
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              Description
              Catalogue Number100971
              SynonymsEthyl alcohol, EtOH
              References
              Product Information
              CAS number64-17-5
              EC index number603-002-00-5
              EC number200-578-6
              GradePh Eur,BP,ChP
              Hill FormulaC₂H₆O
              Chemical formulaC₂H₅OH
              Molar Mass46.07 g/mol
              HS Code2207 10 90
              Structure formula ImageStructure formula Image
              Quality LevelMQ500
              Applications
              Biological Information
              Physicochemical Information
              Boiling point78 °C (1013 hPa)
              Density0.805 g/cm3 (20 °C)
              Explosion limit2.5 - 13.5 %(V)
              Flash point17 °C
              Ignition temperature425 °C
              Melting Point-117 °C
              pH value7.0 (10 g/l, H₂O, 20 °C)
              Vapor pressure57.26 hPa (19.6 °C)
              Dimensions
              Materials Information
              Toxicological Information
              LD 50 oralLD50 Rat 6200 mg/kg
              Safety Information according to GHS
              Hazard Pictogram(s) Hazard Pictogram(s)
              Hazard Pictogram(s)
              Hazard Statement(s)H225: Highly flammable liquid and vapour.
              H319: Causes serious eye irritation.
              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.
              P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
              P403 + P233: Store in a well-ventilated place. Keep container tightly closed.
              Signal WordDanger
              RTECSKQ6300000
              Storage class3 Flammable liquids
              WGKWGK 1 slightly hazardous to water
              Disposal1
              Strongly contaminated halogen-free organic solvents: container A.
              Safety Information
              Categories of dangerhighly flammable
              Product Usage Statements
              Storage and Shipping Information
              StorageStore at +2°C to +25°C.
              Packaging Information
              Transport Information
              Declaration (railroad and road) ADR, RIDUN 1170 , 3, II
              Declaration (transport by air) IATA-DGRUN 1170 , 3, II
              Declaration (transport by sea) IMDG-CodeUN 1170 , 3, II
              Supplemental Information
              Specifications
              Assay (m/m)92.6 - 95.2 %
              Assay (V/V)95.1 - 96.9 %
              Identity (IR)conforms
              Identity 1 (ChP)conforms
              Appearanceconforms
              Clarity and color of solution (ChP)conforms
              Acidity or alkalinity≤ 30 ppm
              Acidity or alkalinity (ChP)conforms
              Density (d 20 °C/20 °C)0.805 - 0.812
              Density (d 20 °C/20 °C) (ChP)≤ 0.8129
              Absorbance (at 240 nm)≤ 0.40
              Absorbance (between 250 nm and 260 nm)≤ 0.30
              Absorbance (between 270 nm and 340 nm)≤ 0.10
              The spectrum shows a steadily descending curve with no observable peaks or shouldersconforms
              Absorbance (ChP) (at 240 nm)≤ 0.08
              Absorbance (ChP) (between 250 nm and 260 nm)≤ 0.06
              Absorbance (ChP) (between 270 nm and 340 nm)≤ 0.02
              Volatile impurities (GC) (Acetaldehyde and Acetal)≤ 10 ppm
              Volatile impurities (GC) (Benzene)≤ 2 ppm
              Volatile impurities (GC) (Methanol)≤ 100 ppm
              Volatile impurities (GC) (Total of other impurities)≤ 300 ppm
              Other residual solvents (ICH Q3C)excluded by production process
              Evaporation residue≤ 25 mg/l
              Non-volatile matter≤ 25 mg/l
              Bacterial endotoxins≤ 2.5
                                                                                         Parameter with periodic testing
              ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
              Total aerobic microbial count (TAMC)                  ≤ 100                      CFU/ml
              Total combined yeasts/moulds count (TYMC)      ≤ 10                        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 (*).
              Conforms to Ph Eur, BP, ChP.
              Global Trade Item Number
              Catalogue Number GTIN
              1.00971.1000 04022536012698
              1.00971.2500 04022536012711
              1.00971.9950 04027269055400

              Documentation

              Material Qualification Dossier

              TitleVersion
              8.1

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Ethanol 96% SDS

              Title

              Safety Data Sheet (SDS) 

              Ethanol 96% Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1.00971.1000 Glass bottlePDF Specification Document
              1.00971.2500 Glass bottlePDF Specification Document
              1.00971.9950 Plastic IBCPDF Specification Document

              Certificates

              Title

              Brochure

              Title
              バイオ医薬品製造用製品ガイド