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108346 D(+)-Glucose monohydrate

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

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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          1083469450
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              Double PE Sack 18 x 25 kg
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              CO1E1083469029
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                  25 kg
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                  CO1E1083469450
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                      450 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
                      1083469450 04022536928487
                      CO1E1083469029 0
                      CO1E1083469450 0

                      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
                      1083469450 Double PE SackPDF Specification Document
                      CO1E1083469029 PDF Specification Document
                      CO1E1083469450 PDF Specification Document

                      Certificates

                      Title

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                      Categories

                      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
                      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