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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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Replacement Information

Key Spec Table

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

Pricing & Availability

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1083462500
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      		 Plastic bottle 2.5 kg
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      1083469029
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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 11
          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
          1083462500 04027269028817
          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
          1083462500 Plastic bottlePDF Specification Document
          1083469029 Double PE SackPDF Specification Document

          Certificates

          Title

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          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
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          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