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103140 Parteck® SI 400 (Sorbitol)

EMPROVE® ESSENTIAL Ph Eur,BP,NF,FCC,JSFA,E 420

Parteck® SI 400 (Sorbitol) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: D-Glucitol

CAS #: 50-70-4 EC Number: 200-061-5 Molar Mass: 182.17 g/mol Hill Formula: C₆H₁₄O₆ Grade: Ph Eur,BP,NF,FCC,JSFA,E 420
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
50-70-4200-061-5C₆H₁₄O₆182.17 g/molPh Eur,BP,NF,FCC,JSFA,E 420
Description
Catalogue Number103140
SynonymsD-Glucitol
References
Product Information
CAS number50-70-4
EC number200-061-5
GradePh Eur,BP,NF,FCC,JSFA,E 420
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 Point98 - 100 °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
Safety Information
Product Usage Statements
Storage and Shipping Information
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)97.0 - 100.5 %
Identitypasses test
pH-value (10 %; water)3.5 - 7.0
Free acidpasses test
Appearance of solution (10 %; water)passes test
Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance)+4.0 - +7.0 °
Conductivity (25°C) (20 %; water)≤ 20
Chloride (Cl)≤ 0.002 %
Sulfate (SO₄)≤ 0.010 %
Heavy metals as Pb≤ 5 ppm
As (Arsenic)≤ 1 ppm
Ni (Nickel) (#)≤ 1 ppm
Pb (Lead)≤ 0.5 ppm
Ru (Ruthenium) (#)≤ 1 ppm
Related substances (HPLC, Ph. Eur.) (major impurity)≤ 2.0 %
Related substances (HPLC, EP) (Sum of all impurities)≤ 3.0 %
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.8
Reducing sugars (as glucose)≤ 0.11
Sulfated ash≤ 0.02 %
Loss on drying≤ 3.0
Water≤ 1.5 %
Particle size (< 212 µm)≤ 10 %
Particle size (> 850 µm)≤ 10 %
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
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 an indicated (#).
Corresponds to Ph. Eur., BP, JSFA, NF, E 420
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Documentation

Material Qualification Dossier

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10.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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Parteck® SI 400 (Sorbitol) SDS

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Safety Data Sheet (SDS) 

Parteck® SI 400 (Sorbitol) Certificates of Analysis

Product Number PackagingLot Number
103140

Certificates

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