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108346 D(+)-glukóza monohydrát

Přehled

Replacement Information

Tabulka spec. kláve

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

Products

Katalogové čísloBalení ks/bal.
1083462500 Plastová láhev 2.5 kg
1083469029 Dvojitý PE pytel 25 kg
1083469050 Plastový sud 50 kg
1083469450 Dvojitý PE pytel 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 Ostatní kapalné a tuhé látky
WGKWGK 1 látka mírně ohrožující vody
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladovat od +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
Katalogové číslo 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

Katalogové číslo BaleníSpecifikaceČíslo šarže
1083462500 Plastová láhevSpecifikující dokument ve formátu PDF
1083469029 Dvojitý PE pytelSpecifikující dokument ve formátu PDF
1083469050 Plastový sudSpecifikující dokument ve formátu PDF
1083469450 Dvojitý PE pytelSpecifikující dokument ve formátu PDF

Certificates

Title

Související produkty a aplikace

Související produkty: Application Facete

Související produkty: Brand Facete

Kategorie

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