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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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105980
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개요

Replacement Information

주요 사양표

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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      		 Plastic bottle 2.5 kg
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          		 Double PE Sack 20 kg
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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
          카탈로그 번호 GTIN
          1.05980.2500 04022536961378
          1.05980.9024 04022536994086

          Documentation

          Material Qualification Dossier

          TitleVersion
          8.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          D(-)-Mannitol MSDS

          타이틀

          물질안전보건자료(MSDS) 

          D(-)-Mannitol Certificates of Analysis

          제품 번호 패킹스펙로트(lot) 번호
          1.05980.2500 Plastic bottlePDF 사양 문건
          1.05980.9024 Double PE SackPDF 사양 문건

          Certificates

          Title

          관련 제품 및 어플리케이션

          관련 제품: Application Facete

          Binders and Fillers
          Tonicity Agents
          Surfactants and Stabilizers

          관련 제품: Brand Facete

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          카테고리

          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
          Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Binders and Fillers
          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