112635 | Parteck® Delta M (Mannitol)

112635
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      Overview

      Replacement Information

      Key Spec Table

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

      Pricing & Availability

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      1126351000
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          Plastic bottle 1 kg
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          1126359025
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              Fibre carton 25 kg
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              Description
              Catalogue Number112635
              References
              Product Information
              CAS number69-65-8
              EC number200-711-8
              GradePh Eur,BP,USP,JP,E 421
              Hill FormulaC₆H₁₄O₆
              Molar Mass182.17 g/mol
              HS Code2905 43 00
              Structure 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
              StorageStore at +15°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
              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)≤ 0.0005 %
              Ni (Nickel)≤ 0.0001 %
              Pb (Lead)≤ 0.00005 %
              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 %
              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
              Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present.
              Corresponds to Ph. Eur., BP, USP, JP, E 421
              Conforms to the purity criteria on food additives according to the current European Commision Regulation.

              Documentation

              Material Qualification Dossier

              Title

              Quality Management Dossier

              Title

              Operational Excellence Dossier

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              SDS

              Title

              Safety Data Sheet (SDS) 

              Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1126351000 Plastic bottlePDF Specification Document
              1126359025 Fibre cartonPDF Specification Document

              Certificates

              Title