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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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      		 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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              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

              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

              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