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108346 D-(+)-Glukoza, monohydrat

EMPROVE® EXPERT Ph Eur,BP,JP,USP

D-(+)-Glukoza, monohydrat 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
108346
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Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1083469029 Podwójny worek PE 25 kg
1083469450 Podwójny worek PE 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 Szczur 25800 mg/kg
Safety Information according to GHS
Storage class10 - 13 Inne substancje ciekłe i stałe
WGKWGK 1 lekkie zanieczyszczenie wody
Safety Information
Product Usage Statements
Storage and Shipping Information
StoragePrzechowywać w +15°C do +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
Numer katalogowy GTIN
1083469029 04022536928470
1083469450 04022536928487

Documentation

Emprove Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

D-(+)-Glukoza, monohydrat MSDS

Title

Safety Data Sheet (SDS) 

D-(+)-Glukoza, monohydrat Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1083469029 Podwójny worek PEDokument ze specyfikacją, w formacie PDF
1083469450 Podwójny worek PEDokument ze specyfikacją, w formacie PDF

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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