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100894 Sukralosa

EMPROVE® ESSENTIAL Ph Eur,ChP,NF,JPE

Sukralosa 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,NF,JPE
100894
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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,NF,JPE

Products

Katalogové čísloBalení ks/bal.
1008940010 Skleněná láhev 10 g
1008941000 Lepenková bedna 1 kg
1008949010 Lepenková bedna 10 kg
Description
Catalogue Number100894
References
Product Information
CAS number56038-13-2
EC number259-952-2
GradePh Eur,ChP,NF,JPE
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)balled 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)≤ 12 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, NF, JPE
Global Trade Item Number
Katalogové číslo GTIN
1008940010 04027269161323
1008941000 04027269161347
1008949010 04027269161361

Documentation

Material Qualification Dossier

TitleVersion
8.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sukralosa MSDS

Title

Safety Data Sheet (SDS) 

Sukralosa Certificates of Analysis

Katalogové číslo BaleníSpecifikaceČíslo šarže
1008940010 Skleněná láhevSpecifikující dokument ve formátu PDF
1008941000 Lepenková bednaSpecifikující dokument ve formátu PDF
1008949010 Lepenková bednaSpecifikující dokument ve formátu PDF

Certificates

Title

Brochure

Title
Two ways to ace the taste test

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