108346 D(+)-Glucose monohydrate

108346
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      77938-63-7 200-075-1 C₆H₁₂O₆*H₂O 198.17 g/mol Ph Eur,BP,USP

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      Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
      1083462500
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          Plastic bottle 2.5 kg
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          1.08346.9029
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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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                  Description
                  Catalogue Number108346
                  References
                  Product Information
                  CAS number77938-63-7
                  EC number200-075-1
                  GradePh Eur,BP,USP
                  Hill FormulaC₆H₁₂O₆*H₂O
                  Molar Mass198.17 g/mol
                  HS Code1702 30 50
                  Structure formula ImageStructure formula Image
                  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
                  Supplemental Information
                  Specifications
                  Assay (calc. on anhydrous substance)97.5 - 102.0 %
                  Identity (IR)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
                  Heavy metals (as Pb)≤ 5 ppm
                  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, USP

                  Documentation

                  Material Qualification Dossier

                  Title

                  Quality Management Dossier

                  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
                  1.08346.9029 Double PE SackPDF Specification Document
                  1083469450 Double PE SackPDF Specification Document

                  Certificates

                  Title

                  Brochure

                  Title
                  MultiPharmTM Minerals for Renal Care

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