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108197 Tabletovacie plnivo K (celulózový prášok)

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF

Tabletovacie plnivo K (celulózový prášok) 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
108197
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Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
1081979020 Plastový sud 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) (kaša)
Bulk density70 - 400 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Potkan > 5000 mg/kg
LD 50 dermalLD50 Králik > 2000 mg/kg
Safety Information according to GHS
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +15°C až +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
Catalogue Number GTIN
1081979020 04022536101576

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Tabletovacie plnivo K (celulózový prášok) MSDS

Title

Safety Data Sheet (SDS) 

Tabletovacie plnivo K (celulózový prášok) Certificates of Analysis

Product Number PackagingSpecificationLot Number
1081979020 Plastový sudPDF Specification Document

Certificates

Title