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100895 Szukralóz szemcsés

EMPROVE® ESSENTIAL Ph Eur,ChP,JPE,NF

Szukralóz szemcsés 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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Áttekintés

Replacement Information

Kulcsspecifikációk táblázata

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

Products

KatalógusszámCsomagolás Menny./csomag
1008950010 Üvegpalack 10 g
1008951000 Kartondoboz 1 kg
1008959010 Kartondoboz 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) Nem alkalmazható
Melting Point114.5 °C (bomlás)
pH value6 - 8 (100 g/l, H₂O, 20 °C)
Solubility300 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Patkány > 10000 mg/kg
Safety Information according to GHS
RTECSLW5440140
Storage class10 - 13 Egyéb folyadékok és szilárd anyagok
WGKWGK 2 jelentősen veszélyezteti a vizeket
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
Storage+15°C és +25°C között tárolandó.
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
Katalógusszám GTIN
1008950010 04027269161392
1008951000 04027269161415
1008959010 04027269161439

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Szukralóz szemcsés MSDS

Title

Safety Data Sheet (SDS) 

Szukralóz szemcsés Certificates of Analysis

Cikkszám CsomagolásSpecifikációSarzsszám
1008950010 ÜvegpalackSpecifikációk, PDF dokumentum
1008951000 KartondobozSpecifikációk, PDF dokumentum
1008959010 KartondobozSpecifikációk, PDF dokumentum

Certificates

Title

Technical Info

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

Kapcsolódó termékek és alkalmazások

Kapcsolódó termékek gyártója: Application Facete

Taste Modifiers

Kapcsolódó termékek gyártója: Brand Facete

EMPROVE®

Kategóriák

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