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103557 Parteck® SI 450 (Sorbitol)

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
50-70-4200-061-5C₆H₁₄O₆182.17 g/molNF,FCC,JSFA
Description
Catalogue Number103557
SynonymsD-Glucitol
References
Product Information
CAS number50-70-4
EC number200-061-5
GradeNF,FCC,JSFA
Hill FormulaC₆H₁₄O₆
Molar Mass182.17 g/mol
HS Code2905 44 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.49 g/cm3 (20 °C)
Ignition temperature420 °C
Melting Point94 - 96 °C
pH value5.0 - 7 (182 g/l, H₂O, 25 °C)
Vapor pressure<0.1 hPa (25 °C)
Bulk density450 kg/m3
Solubility2350 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat 15900 mg/kg
Safety Information according to GHS
RTECSLZ4290000
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 +2°C to +25°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 (HPLC, calc.on anhydrous substance)91.0 - 100.5 %
Identitypasses test
pH-value (10 %; water)3.5 - 7.0
Free acidpasses test
Chloride (Cl)≤ 0.002 %
Sulfate (SO₄)≤ 0.010 %
Heavy metals (as Pb)≤ 5 ppm
As (Arsenic)≤ 1 ppm
Ni (Nickel) (#)≤ 1 ppm
Pb (Lead)≤ 1 ppm
Ru (Ruthenium) (#)≤ 1 ppm
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.8
Reducing sugars (as glucose)≤ 0.2
Sulfated ash≤ 0.02 %
Water≤ 1.5 %
Residual solvents (ICH Q3C)excluded by manufacturing process
Microbiological testpasses test
Colony count (aerobic bacteria (TAMC))≤ 5*10²
Colony count (Yeasts and moulds (TYMC))≤ 10²
Salmonella spp.in 10g Substance not detectable
E.coliin 1g substance not detectable
Staphylococcus aureusin 1g substance not detectable
Pseudomonas aeruginosain 1g substance not detectable
Candida albicansIn 1g substance not detectable
Loss on drying≤ 3.0
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 (#).
Corresponds to NF, FCC, JSFA

Documentation

Material Qualification Dossier

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11.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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Parteck® SI 450 (Sorbitol) SDS

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Safety Data Sheet (SDS) 

Certificates

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