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105980 D(-)-Mannitol

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

D(-)-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,FCC,E 421
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Key Spec Table

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

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              Description
              Catalogue Number105980
              References
              Product Information
              CAS number69-65-8
              EC number200-711-8
              GradePh Eur,BP,ChP,JP,USP,FCC,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 Point164 - 169 °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 (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 °C
              Spec. rotation (α 25/D; 1 %; molybdate complex, calc. on anhydrous substance)137 - 145 °
              Conductivity (25°C) (20 %; water)≤ 20
              Arsenic (As)≤ 2 ppm
              Ni (Nickel) (#)≤ 1 ppm
              Pb (Lead)≤ 0.5 ppm
              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 (< 20 µm)≤ 15 %
              Particle size (> 212 µm)≤ 10 %
              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, FCC, E 421
              Conforms to the purity criteria on food additives according to the current European Commission Regulation.
              Global Trade Item Number
              Catalogue Number GTIN
              1059802500 04022536961378
              1059809024 04022536994086
              1059809050 04022536070551

              Documentation

              Material Qualification Dossier

              TitleVersion
              8.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              D(-)-Mannitol SDS

              Title

              Safety Data Sheet (SDS) 

              D(-)-Mannitol Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1059802500 Plastic bottlePDF Specification Document
              1059809024 Double PE SackPDF Specification Document
              1059809050 Fibre cartonPDF Specification Document

              Certificates

              Title

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              Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Tonicity Agents
              Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Tonicity Agents
              Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers