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102975 Sorbitol FP, kvapalný

(sorbitolový sirup, nekryštalizujúci) vhodný použitie ako excipient EMPROVE® ESSENTIAL Ph Eur,BP,NF,E 420

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

Synonyms: Sorbit®, Sorbitol®, Sionon®, Sorbo®

Grade: Ph Eur,BP,NF,E 420
102975
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Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP,NF,E 420

Products

Catalogue NumberPackaging Qty/Pack
1029752500 Sklená flaša 2.5 l
1029759050 Ocelový sud 50 kg
1029759270 Ocelový sud 270 kg
Description
Catalogue Number102975
SynonymsSorbit®, Sorbitol®, Sionon®, Sorbo®
References
Product Information
GradePh Eur,BP,NF,E 420
HS Code3824 60 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.3 g/cm3 (20 °C)
pH value6 (H₂O, 20 °C) (50 % roztok)
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +15°C až +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
Solid matter69.0 - 72.0 %
Sorbitol (HPLC, calc.on anhydrous substance)72.0 - 92.0 %
Sorbitol (HPLC)≥ 50.0 %
Identitypasses test
pH-value (14 %; water)5.0 - 7.5
Appearance of solution (14 %; water)passes test
conductivity (25°C)≤ 10
As (Arsenic)≤ 1 ppm
Ni (Nickel) (calc. on anhydrous substance) (*)≤ 1 ppm
Pb (Lead)≤ 0.5 ppm
Ethylene glycol (HPLC)≤ 0.10 %
Diethylene glycol (HPLC)≤ 0.10 %
Mannitol (HPLC)≤ 6.5
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 9.3 %
Reducing sugars (as glucose)≤ 0.2 %
Sulfated ash (calc.on anhydrous substance)≤ 0.1
Water28.5 - 31.0 %
Residual solvents (ICH Q3C)excluded by manufacturing process
Microbiological testpasses test
Colony count (aerobic bacteria (TAMC))≤ 10³
Colony count (Yeasts and moulds (TYMC))≤ 10²
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, NF, E 420
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Global Trade Item Number
Catalogue Number GTIN
1029752500 04065267183756
1029759050 04022536038469
1029759270 04022536038476

Documentation

Material Qualification Dossier

TitleVersion
10.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sorbitol FP, kvapalný MSDS

Title

Safety Data Sheet (SDS) 

Sorbitol FP, kvapalný Certificates of Analysis

Product Number PackagingSpecificationLot Number
1029752500 Sklená flašaPDF Specification Document
1029759050 Ocelový sudPDF Specification Document
1029759270 Ocelový sudPDF Specification Document

Certificates

Title