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108346 D(+)-Glucose monohydrate

EMPROVE® EXPERT Ph Eur,BP,JP,USP

D(+)-Glucose monohydrate MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 77938-63-7 EC Number: 200-075-1 Molar Mass: 198.17 g/mol Hill Formula: C₆H₁₂O₆*H₂O Grade: Ph Eur,BP,JP,USP
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108346
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
77938-63-7200-075-1C₆H₁₂O₆*H₂O198.17 g/molPh Eur,BP,JP,USP

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      		 Double PE Sack 25 kg
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      Description
      Catalogue Number108346
      References
      Product Information
      CAS number77938-63-7
      EC number200-075-1
      GradePh Eur,BP,JP,USP
      Hill FormulaC₆H₁₂O₆*H₂O
      Molar Mass198.17 g/mol
      HS Code1702 30 50
      Structure formula ImageStructure formula Image
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density0.62 g/cm3
      Ignition temperature500 °C
      Melting Point146 °C
      pH value4.0 - 6.0 (500 g/l, H₂O, 20 °C)
      Bulk density630 kg/m3
      Solubility1000 g/l
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat 25800 mg/kg
      Safety Information according to GHS
      Storage class10 - 13 Other liquids and solids
      WGKWGK 1 slightly hazardous to water
      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 anhydrous substance) Ph Eur97.5 - 102.0 %
      Assay (HPLC, calc. on anhydrous substance) USP97.5 - 102.0 %
      Assay (HPLC, calc. on anhydrous substance) JP97.5 - 102.0 %
      Identity (IR)passes test
      Identity (wet chemistry)passes test
      Identity (spec. rotation calc. on anhydrous substance)passes test
      Identity (HPLC)passes test
      Identity (water)passes test
      Appearance of solutionpasses test
      Color and clarity of solutionpasses test
      Conductivity≤ 20 µS/cm
      Cu (Copper)≤ 0.0025 %
      Zn (Zinc)≤ 0.0025 %
      Related substances [sum of impurities A (maltose) and B (isomaltose)!≤ 0.4 %
      Related substances [Impurity C (maltotriose)!≤ 0.2 %
      Related substances [Impurity D (fructose)!≤ 0.15 %
      Related substances (unspecified impurities)≤ 0.10 %
      Related substances (Sum of all impurities)≤ 0.5 %
      Dextrinpasses test
      Soluble starch, sulfite≤ 15 ppm
      Residual solvents (ICH Q3C)excluded by manufacturing process
      Water (according to Karl Fischer)7.5 - 9.5 %
      Endotoxins≤ 2.5 I.U./g
      Microbiological purity (Total aerobic microbial count (TAMC))≤ 1000 CFU/g
      Microbiological purity (Total yeast and mould count (TYMC))≤ 100 CFU/g
      Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
      Escherichia coli (absent in 1 g)passes test
      Pseudomonas aeruginosa (absent in 1 g)passes test
      Staphylococcus aureus (absent in 1 g)passes test
      Candida albicans (absent in 1 g)passes test
      Salmonella ssp (absent in 10 g)passes test
      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
      corresponds to Ph Eur, BP, JP, USP
      Global Trade Item Number
      Catalogue Number GTIN
      1083469029 04022536928470

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      D(+)-Glucose monohydrate SDS

      Title

      Safety Data Sheet (SDS) 

      D(+)-Glucose monohydrate Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1083469029 Double PE SackPDF Specification Document

      Certificates

      Title

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      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Tonicity Agents
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Taste Modifiers
      Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Binders and Fillers
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers
      Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Taste Modifiers
      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Tonicity Agents
      Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Taste Modifiers