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108346 D(+)-Glukóza monohydrát

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

Products

Catalogue NumberPackaging Qty/Pack
1083462500 Plastová flaša 2.5 kg
1083469029 Dvojité PE vrecko 25 kg
1083469050 Plastový sud 50 kg
1083469450 Dvojité PE vrecko 18 x 25 kg
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 Potkan 25800 mg/kg
Safety Information according to GHS
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +15°C až +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
1083469050 04022536103266
1083469450 04022536928487

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

D(+)-Glukóza monohydrát MSDS

Title

Safety Data Sheet (SDS) 

D(+)-Glukóza monohydrát Certificates of Analysis

Product Number PackagingSpecificationLot Number
1083462500 Plastová flašaPDF Specification Document
1083469029 Dvojité PE vreckoPDF Specification Document
1083469050 Plastový sudPDF Specification Document
1083469450 Dvojité PE vreckoPDF 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