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100895 Sukralosa granulát

EMPROVE® ESSENTIAL Ph Eur,ChP,JPE,NF

Sukralosa granulát MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 56038-13-2 EC Number: 259-952-2 Molar Mass: 397.63 g/mol Hill Formula: C₁₂H₁₉Cl₃O₈ Grade: Ph Eur,ChP,JPE,NF
100895
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Replacement Information

Tabulka spec. kláve

CAS #EC NumberHill FormulaMolar MassGrade Value
56038-13-2259-952-2C₁₂H₁₉Cl₃O₈397.63 g/molPh Eur,ChP,JPE,NF

Products

Katalogové čísloBalení ks/bal.
1008950010 Skleněná láhev 10 g
1008951000 Lepenková krabice 1 kg
1008959010 Lepenková bedna 10 kg
Description
Catalogue Number100895
References
Product Information
CAS number56038-13-2
EC number259-952-2
GradePh Eur,ChP,JPE,NF
Hill FormulaC₁₂H₁₉Cl₃O₈
Molar Mass397.63 g/mol
HS Code2932 14 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.62 g/cm3 (20 °C) Nevztahuje se
Melting Point114.5 °C (rozklad)
pH value6 - 8 (100 g/l, H₂O, 20 °C)
Solubility300 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Potkan > 10000 mg/kg
Safety Information according to GHS
RTECSLW5440140
Storage class10 - 13 Ostatní kapalné a tuhé látky
WGKWGK 2 významně ohrožuje vodní prostředí
Disposal3
Relativně nereaktivní organické reagencie mohou být shromažďovány v kontejneru A. Pokud jsou halogenované, musí být umístěny v kontejneru B. U pevných reziduí použijte kontejner C.
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-DGRUN 1845 , 9,
Declaration (transport by sea) IMDG-CodeUN 1845 , 9,
Supplemental Information
Specifications
Assay (HPLC, calc. on anhydrous substance)98.0 - 102.0 %
Assay (HPLC, calc. on anhydrous substance) (ChP)98.0 - 102.0 %
Assay (calc. on anhydrous substance) (JPE)98.0 - 102.0 %
Appearance of substance (description)granular powder
Appearance of substance (color)almost white
Identity (HPLC)conforms
Identity (TLC)conforms
Identity (IR)conforms
Identity (Spec. rotation (Ph Eur))conforms
Spec. Rotation [α²0/D (calc. on anhydrous substance) (Ph Eur/JPE)+84.0 - +87.5 °
Spec. Rotation [α²0/D (calc. on anhydrous substance) (NF/ChP)+84.0 - +87.5 °
Appearance of solution (10 %, water)conforms
pH-TestDecrease of 1 pH unit max.
Heavy metals (as Pb)≤ 0.0010 %
Methanol≤ 0.1 %
Methanol (ChP)≤ 0.1 %
Cyclohexane≤ 3880 ppm
N,N-Dimethylformamide≤ 880 ppm
Acetic acid≤ 5000 ppm
Ethyl acetate≤ 5000 ppm
Other residual solvents (ICH Q3C)excluded by production process
Hydrolysis products≤ 0.1 %
Impurities H and I≤ 0.1 %
Monosaccharide-Chloride (as Fructose)≤ 0.16 %
Related substances (Ph Eur/ChP)≤ 0.5 %
Related substances (NF)≤ 0.5 %
Other Disaccharide-Chlorides≤ 0.5 %
Triphenylphosphine oxide≤ 150 ppm
Residue on ignition≤ 0.7 %
Water (according to Karl Fischer)≤ 2.0 %
Particle Size (d90)≥ 80 µm
Microbiological purity (Total aerobic microbial count (TAMC))≤ 1E+03 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 1E+02 CFU/g
Bile tolerant Gram negative Bacteria (absent in 1 g)conforms
Escherichia coli (absent in 1 g)conforms
Pseudomonas aeruginosa (absent in 1 g)conforms
Staphylococcus aureus (absent in 1 g)conforms
Candida albicans (absent in 1 g)conforms
Salmonella ssp (absent in 10 g)conforms
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, ChP, JPE, NF
Global Trade Item Number
Katalogové číslo GTIN
1008950010 04027269161392
1008951000 04027269161415
1008959010 04027269161439

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sukralosa granulát MSDS

Title

Safety Data Sheet (SDS) 

Sukralosa granulát Certificates of Analysis

Katalogové číslo BaleníSpecifikaceČíslo šarže
1008950010 Skleněná láhevSpecifikující dokument ve formátu PDF
1008951000 Lepenková krabiceSpecifikující dokument ve formátu PDF
1008959010 Lepenková bednaSpecifikující dokument ve formátu PDF

Certificates

Title

Technical Info

Title
Taste Optimization in Solid Dose: A Human Sensory Panel Study

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Kategorie

Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Sweeteners
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Taste Modifiers
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Taste Modifiers
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Taste Modifiers