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480940 Ethanol 20 % (v/v) with 150 mMol/L sodium chloride solution

Overview

Replacement Information

Products

Catalogue NumberPackaging Qty/Pack
4809409190 Barrel PE/met 190 l
4809409950 Plastic IBC 950 l
Description
Catalogue Number480940
References
Product Information
HS Code3824 99 92
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density0.970 g/cm3 (20 °C)
Flash point35 °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, RIDKein Gefahrgut
Declaration (transport by air) IATA-DGRNo Dangerous Good
Declaration (transport by sea) IMDG-CodeNo Dangerous Good
Supplemental Information
Specifications
Assay (Ethanol)19.5 - 20.5 % (v/v)
Assay (NaCl)145 - 155 mmol/l
Total aerobic microbial count (TAMC)≤ 10 CFU/ml
Total combined yeasts/moulds count (TYMC)≤ 10 CFU/ml
Bacterial endotoxins≤ 2.5 I.U./ml
Lotnumber (Ethanol)
Lotnumber (NaCl)
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. Ph Eur, BP, ChP, JP, USP) & Sodium chloride (acc. Ph Eur, BP, USP) & purified water (acc. Ph Eur)
Filtered by 0.2 µm Filter
Global Trade Item Number
Catalogue Number GTIN
4809409190 04027269302245
4809409950 04027269295981

Documentation

Material Qualification Dossier

TitleVersion
6.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Ethanol 20 % (v/v) with 150 mMol/L sodium chloride solution SDS

Title

Safety Data Sheet (SDS) 

Ethanol 20 % (v/v) with 150 mMol/L sodium chloride solution Certificates of Analysis

Product Number PackagingSpecificationLot Number
4809409190 Barrel PE/metPDF Specification Document
4809409950 Plastic IBCPDF Specification Document

Certificates

Title