100419 Parteck® M 200 (Mannitol)

100419
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      69-65-8 200-711-8 C₆H₁₄O₆ 182.17 g/mol Ph Eur,BP,JP,USP,E 421

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      Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
      1004192500
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          Plastic bottle 2.5 kg
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          1004199025
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              Fibre carton 25 kg
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              1.00419.9050
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                  Fibre carton 50 kg
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                  Description
                  Catalogue Number100419
                  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
                  Structure formula ImageStructure formula Image
                  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
                  WGKNWG not water endangering
                  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
                  StorageStorage temperature: no restrictions.
                  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)≤ 15 %
                  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, 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 200 (Mannitol) SDS

                  Title

                  Safety Data Sheet (SDS) 

                  Parteck® M 200 (Mannitol) Certificates of Analysis

                  Product Number PackagingSpecificationLot Number
                  1004192500 Plastic bottlePDF Specification Document
                  1004199025 Fibre cartonPDF Specification Document
                  1.00419.9050 Fibre cartonPDF Specification Document

                  Certificates

                  Title

                  Brochure

                  Title
                  MultiPharmTM Minerals for Solid Dosage Forms

                  Technical Info

                  Title
                  1.00419 Change Notification Letter