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108197 Tabletting aid K (cellulose powder)

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF

Tabletting aid K (cellulose powder) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 9004-34-6 EC Number: 232-674-9 Chemical Formula: (C₆H₁₀O₅)n Grade: Ph Eur,BP,JP,NF
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Overview

Replacement Information

Key Specifications Table

CAS #EC NumberChemical FormulaGrade Value
9004-34-6232-674-9(C₆H₁₀O₅)nPh Eur,BP,JP,NF

Products

Catalog NumberPackaging Qty/Pack
1081979020 Plastic drum 20 kg
Description
Catalogue Number108197
References
Product Information
CAS number9004-34-6
EC number232-674-9
GradePh Eur,BP,JP,NF
Chemical formula(C₆H₁₀O₅)n
HS Code3912 90 90
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.5 g/cm3 (20 °C)
Ignition temperature232 °C
pH value5 - 7.5 (100 g/l, H₂O, 20 °C) (slurry)
Bulk density70 - 400 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat > 5000 mg/kg
LD 50 dermalLD50 Rabbit > 2000 mg/kg
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +15°C to +25°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Identity (wet chemistry)passes test
Identity (suspension test)passes test
Identity (degree of polymerization)440 - 2250
Ether-soluble substances≤ 0.15 %
Water-soluble substances≤ 1.5 %
Solubilitypasses test
pH-value5.0 - 7.5
Al (Aluminium)≤ 10 ppm
Organic impuritiespasses test
Residual solvents (ICH Q3C)excluded by production process
Bulk density0.070 - 0.100 g/cm³
Sulfated ash≤ 0.3 %
Loss on Drying (105 °C)≤ 6.0 %
Particle size (> 32 µm)≤ 90 %
Particle size (> 90 µm)≤ 35 %
Particle size (> 400 µm)≤ 1 %
Microbiological purity (Total aerobic microbial count (TAMC))≤ 1E+03 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 1E+02 CFU/g
Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
Escherichia coli (absent in 1 g)passes test
Pseudomonas aeruginosa (absent in 1 g)passes test
Staphylococcus aureus (absent in 1 g)passes test
Candida albicans (absent in 1 g)passes test
Salmonella ssp (absent in 10 g)
passes test
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 the purity criteria on food additives according to the current European Commission Regulation.
Corresponds to Ph Eur, BP, JP, NF
passes test
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 the purity criteria on food additives according to the current European Commission Regulation.
Corresponds to Ph Eur, BP, JP, NF
Global Trade Item Number
Catalog Number GTIN
1081979020 04022536101576

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Tabletting aid K (cellulose powder) SDS

Title

Safety Data Sheet (SDS) 

Tabletting aid K (cellulose powder) Certificates of Analysis

Product Number PackagingSpecificationLot Number
1081979020 Plastic drumPDF Specification Document

Certificates

Title