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108197 Środek do tabletkowania K (proszek celulozowy)

Przegląd

Replacement Information

Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1081979020 Beben plastikowy 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) (szlam)
Bulk density70 - 400 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Szczur > 5000 mg/kg
LD 50 dermalLD50 Królik > 2000 mg/kg
Safety Information according to GHS
Storage class10 - 13 Inne substancje ciekłe i stałe
WGKWGK 1 lekkie zanieczyszczenie wody
Disposal3
Względnie niereaktywne odczynniki organiczne należy zbierać w Kategorii A. Odczynniki chlorowcowane należy umieszczać w Kategorii B. Do pozostałości stałych stosować Kategorię C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StoragePrzechowywać w +15°C do +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
Numer katalogowy GTIN
1081979020 04022536101576

Documentation

Emprove Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Środek do tabletkowania K (proszek celulozowy) MSDS

Title

Safety Data Sheet (SDS) 

Środek do tabletkowania K (proszek celulozowy) Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1081979020 Beben plastikowyDokument ze specyfikacją, w formacie PDF

Certificates

Title