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100493 Parteck® M 300 (Mannitol)

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

100493
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Katalogové čísloBalení ks/bal.
1004932500 Plastová láhev 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 Potkan 13500 mg/kg
Safety Information according to GHS
RTECSOP2060000
Storage class10 - 13 Ostatní kapalné a tuhé látky
WGKWGK 2 látka ohrožující vody
Disposal3
Relativně nereaktivní organické reagencie mohou být shromažďovány v kontejneru A. Pokud jsou halogenované, musí být umístěny v kontejneru B. U pevných reziduí použijte kontejner C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladovat od +2°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
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
Katalogové číslo GTIN
1004932500 04022536958118

Documentation

Parteck® M 300 (Mannitol) MSDS

Title

Safety Data Sheet (SDS) 

Certificates

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