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100493 Parteck® M 300 (Mannitol)

EMPROVE® ESSENTIAL Ph Eur,BP,JP,USP,E 421

100493
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Overview

Replacement Information

Products

Catalogue NumberPackaging Qty/Pack
1.00493.2500 Plastic bottle 2.5 kg
Description
Catalogue Number100493
References
Product Information
CAS number69-65-8
EC number200-711-8
GradePh Eur,BP,JP,USP,E 421
Hill FormulaC₆H₁₄O₆
Molar Mass182.17 g/mol
HS Code2905 43 00
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point290 - 295 °C (4 hPa)
Density1.52 g/cm3 (20 °C)
Ignition temperature410 °C
Melting Point166 - 168 °C
pH value5.0 - 6.5 (182 g/l, H₂O, 25 °C)
Bulk density400 - 500 kg/m3
Solubility213 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat 13500 mg/kg
Safety Information according to GHS
RTECSOP2060000
Storage class10 - 13 Other liquids and solids
WGKWGK 2 obviously 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 dried substance)98.0 - 101.0 %
Identity (NIR)passes test
Appearance of solution (10 %; water)passes test
pH-value (10 %; water)4.5 - 7.5
Melting point165 - 169
Conductivity (25°C) (20 %; water)≤ 20
Heavy metals (as Pb)≤ 5 ppm
Ni (Nickel) (#)≤ 1 ppm
Pb (Lead)≤ 0.5 ppm
Related substances (HPLC) (Sorbitol (Impurity A))≤ 2.0 %
Related substances (HPLC) (Sum of Maltitol and Isomalt (Impurities B and C))≤ 2.0
Related substances (HPLC) (Major unspecified impurity)≤ 0.10 %
Related substances (HPLC) (Sum of all impurities)≤ 2.0 %
Reducing sugars (as glucose)≤ 0.05
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 1
Sulfated ash≤ 0.1
Water≤ 0.5 %
Loss on Drying (105 °C)≤ 0.30 %
Particle size (< 53 µm)≤ 10 %
Particle size (> 500 µm)≤ 15 %
Residual solvents (ICH Q3C)excluded by manufacturing process
Microbiological testpasses test
Colony count (aerobic bacteria (TAMC))≤ 10³
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 and indicated (#).
Corresponds to Ph. Eur., BP, JP, USP, E421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Global Trade Item Number
Catalogue Number GTIN
1.00493.2500 04022536958118

Documentation

Parteck® M 300 (Mannitol) SDS

Title

Safety Data Sheet (SDS) 

Certificates

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