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100419 Parteck M 200 (mannitol)

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

Parteck M 200 (mannitol) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 69-65-8 EC Number: 200-711-8 Molar Mass: 182.17 g/mol Hill Formula: C₆H₁₄O₆ Grade: Ph Eur,BP,ChP,JP,USP,E 421
100419
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Tabela kluczowych gatunków

CAS #EC NumberHill FormulaMolar MassGrade Value
69-65-8200-711-8C₆H₁₄O₆182.17 g/molPh Eur,BP,ChP,JP,USP,E 421

Products

Numer katalogowyOpakowanie Ilość/opak.
1004199025 Pudlo tekturowe 25 kg
1004199050 Pudlo tekturowe 50 kg
Description
Catalogue Number100419
References
Product Information
CAS number69-65-8
EC number200-711-8
GradePh Eur,BP,ChP,JP,USP,E 421
Hill FormulaC₆H₁₄O₆
Molar Mass182.17 g/mol
HS Code2905 43 00
Structure formula ImageStructure formula Image
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 Szczur 13500 mg/kg
Safety Information according to GHS
RTECSOP2060000
Storage class10 - 13 Inne substancje ciekłe i stałe
WGKWGK 1 lekkie zanieczyszczenie wody
Disposal3
Względnie niereaktywne odczynniki organiczne należy zbierać w Kategorii A. Odczynniki chlorowcowane należy umieszczać w Kategorii B. Do pozostałości stałych stosować Kategorię C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StoragePrzechowywać w +2°C do +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
Identity (IR-spectrum)passes test
Identity (wet chemistry)passes test
Appearance of solution (13 %; water)passes test
Free acidpasses test
pH-value (10 %; water)4.5 - 7.5
Melting point166 - 169
Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance)137 - 145 °
Conductivity (25°C) (20 %; water)≤ 20
Arsenic (As)≤ 2
Ni (Nickel) (#)≤ 1
Pb (Lead)≤ 0.5
Chloride (Cl)≤ 0.003 %
Sulfate (SO₄)≤ 0.01 %
Heavy metals (as Pb)≤ 5 ppm
Oxalate (C₂O₄)≤ 0.02 %
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 %
Residual solvents (ICH Q3C)excluded by manufacturing process
Related substances (HPLC) (Sum of all impurities)≤ 2.0 %
Reducing sugars after hydrolysis/total sugar (as glucose)≤ 1
Reducing sugars (as glucose)≤ 0.05
Sulfated ash≤ 0.1
Loss on Drying (105 °C)≤ 0.30 %
Water≤ 0.5 %
Particle size (< 53 µm)≤ 15 %
Particle size (> 500 µm)≤ 15 %
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, ChP, JP, USP, E 421
Conforms to the purity criteria on food additives according to the current European Commission Regulation.
Global Trade Item Number
Numer katalogowy GTIN
1004199025 04027269146825
1004199050 04022536696652

Documentation

Emprove Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Parteck M 200 (mannitol) MSDS

Title

Safety Data Sheet (SDS) 

Parteck M 200 (mannitol) Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1004199025 Pudlo tekturoweDokument ze specyfikacją, w formacie PDF
1004199050 Pudlo tekturoweDokument ze specyfikacją, w formacie PDF

Certificates

Title