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100986 乙醇

absolute suitable for use as excipient EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

乙醇 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,JP,USP
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100986
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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,JP,USP

Products

Catalogue NumberPackaging Qty/Pack
1.00986.1000 玻璃瓶 1 l
1.00986.2500 玻璃瓶 2.5 l
1.00986.6010 不鏽鋼滾桶 10 l
1.00986.6025 不鏽鋼滾桶 25 l
1.00986.9180 PE/金屬 圓桶 180 l
Description
Catalogue Number100986
SynonymsEthyl alcohol, EtOH
References
Product Information
CAS number64-17-5
EC index number603-002-00-5
EC number200-578-6
GradePh Eur,BP,ChP,JP,USP
Hill FormulaC₂H₆O
Chemical formulaC₂H₅OH
Molar Mass46.07 g/mol
HS Code2207 10 10
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point78.3 °C (1013 hPa)
Density0.79 g/cm3 (20 °C)
Explosion limit3.1 - 27.7 %(V)
Flash point13 °C
Ignition temperature425 °C
Melting Point-114.5 °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)≥ 99.2 %
Assay (V/V)≥ 99.5 %
Identity (IR)conforms
Identity 1 (ChP)conforms
Appearanceconforms
Clarity of solutionconforms
Color of solutionconforms
Clarity and color of solution (ChP)conforms
Acidity or alkalinity≤ 30 ppm
Acidity or alkalinity (ChP)conforms
Density (d 20 °C/20 °C)0.790 - 0.793
Density (d 15,56 °C/15,56 °C)≤ 0.7962
Density (d 15 °C/15 °C)0.794 - 0.797
Specific gravity (d 15 °C/15 °C)0.79422 - 0.79679
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
Cyclohexane (GC)≤ 50 ppm
Evaporation residue≤ 25 mg/l
Non-volatile matter≤ 25 mg/l
Bacterial endotoxins≤ 2.5 I.U./ml
                                                                           Parameter with periodic testing
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
Total aerobic microbial count (TAMC)                  ≤ 100                      CFU/ml
Total combined yeasts/moulds count (TYMC)      ≤ 10                        CFU/ml
Other residual solvents (ICH Q3C) excluded by production process.
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, JP, USP
Global Trade Item Number
Catalogue Number GTIN
1.00986.1000 04022536013374
1.00986.2500 04022536013428
1.00986.6010 04022536013480
1.00986.6025 04022536013497
1.00986.9180 04022536013503

Documentation

Material Qualification Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

Title

乙醇 MSDS

Title

Safety Data Sheet (SDS) 

乙醇 Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.00986.1000 玻璃瓶PDF Specification Document
1.00986.2500 玻璃瓶PDF Specification Document
1.00986.6010 不鏽鋼滾桶PDF Specification Document
1.00986.6025 不鏽鋼滾桶PDF Specification Document
1.00986.9180 PE/金屬 圓桶PDF Specification Document

Certificates

Title