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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 Specifications Table

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

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1083462500
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      		 Plastic bottle 2.5 kg
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      1083469013
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          		 Bucket, plastic 12 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,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
                  Catalog Number GTIN
                  1083462500 04027269028817
                  1083469013 04027269170585
                  1.08346.9029 04022536928470
                  1083469450 04022536928487

                  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
                  1083469013 Bucket, plasticPDF Specification Document
                  1.08346.9029 Double PE SackPDF Specification Document
                  1083469450 Double PE SackPDF 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