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100494 Parteck® M 100 (Mannitol)

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

Parteck® M 100 (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
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100494
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Replacement Information

Key Spec Table

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

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      		 Plastic bottle 2.5 kg
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      Description
      Catalogue Number100494
      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
      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 1 slightly 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 (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)≤ 0.5
      Water≤ 0.5 %
      Particle size (> 212 µm)≤ 20 %
      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., ChP, BP, JP, USP, E 421
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.
      Corresponds to Ph. Eur., ChP, BP, JP, USP, E 421
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.
      Global Trade Item Number
      Catalogue Number GTIN
      1.00494.2500 04027269048778

      Documentation

      Material Qualification Dossier

      TitleVersion
      10.1

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Parteck® M 100 (Mannitol) SDS

      Title

      Safety Data Sheet (SDS) 

      Parteck® M 100 (Mannitol) Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1.00494.2500 Plastic bottlePDF Specification Document

      Certificates

      Title