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100494 Parteck® M 100 (Mannitol)

Overview

Replacement Information

Key Spec Table

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

Pricing & Availability

Catalogue Number AvailabilityPackaging Qty/Pack Price Quantity
1004942500
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      Plastic bottle 2.5 kg
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      1004949025
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          Fibre carton 25 kg
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          Description
          Catalogue Number100494
          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)
          Ignition temperature410 °C
          Melting Point164 - 169 °C
          pH value5 - 7 (100 g/l, H₂O, 20 °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 (> 212 µm)≤ 20 %
          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, E 421
          Conforms to the purity criteria on food additives according to the current European Commission Regulation.

          Documentation

          Material Qualification Dossier

          Title

          Quality Management Dossier

          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
          1004942500 Plastic bottlePDF Specification Document
          1004949025 Fibre cartonPDF Specification Document

          Certificates

          Title