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102994 Sorbitol liquid

(sorbitol syrup, crystallizing) EMPROVE® ESSENTIAL Ph Eur,BP,ChP,USP,E 420

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

Synonyms: Karion

Grade: Ph Eur,BP,ChP,USP,E 420
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102994
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Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP,ChP,USP,E 420
Description
Catalogue Number102994
SynonymsKarion
References
Product Information
GradePh Eur,BP,ChP,USP,E 420
HS Code2905 44 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.3 g/cm3
pH value6 (H₂O, 20 °C) (50% solution)
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
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
Solid matter69.0 - 72.0 %
Sorbitol (HPLC, calc.on anhydrous substance)92.0 - 101.0 %
Sorbitol (HPLC)≥ 65.0 %
Identitypasses test
Identity (wet chemistry)passes test
Appearance of solution (14 %; water)passes test
pH-value (14 %; water)5.0 - 7.5
conductivity (25°C)≤ 10
Spec. rotation [α²0/D (14%, borate complex)(calc. on anhydrous substance)0.0 - 1.5 °
As (Arsenic)≤ 1 ppm
Ni (Nickel) (calc. on anhydrous substance) (*)≤ 1 ppm
Pb (Lead) (calc. on anhydrous substance)≤ 0.5 ppm
Diethylene glycol (GC)≤ 0.10 %
Ethylene glycol (GC)≤ 0.10 %
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.5
Reducing sugars (as glucose)≤ 0.2
Residual solvents (ICH Q3C)excluded by manufacturing process
Sulfated ash (calc.on anhydrous substance)≤ 0.1
Water28.5 - 31.0 %
Microbiological testpasses test
Colony count (aerobic bacteria (TAMC))(ChP)≤ 10³
Colony count (Yeasts and moulds (TYMC))(ChP)≤ 10²
E.coli (ChP)in 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 and indicated (*).
Corresponds to Ph. Eur., BP, ChP, USP, E 420
Conforms to the purity criteria on food additives according to the current European Commission Regulation.

Documentation

Material Qualification Dossier

TitleVersion
8.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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Sorbitol liquid SDS

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Safety Data Sheet (SDS) 

Sorbitol liquid Certificates of Analysis

Product Number PackagingLot Number
102994

Certificates

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