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100895 Sukraloza ziarnista

EMPROVE® ESSENTIAL Ph Eur,JPE,NF

Sukraloza ziarnista 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,JPE,NF
100895
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Replacement Information

Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1008950010 Butelka szklana 10 g
1008951000 Pudelko kartonowe 1 kg
1008959010 Pudlo tekturowe 10 kg
Description
Catalogue Number100895
References
Product Information
CAS number56038-13-2
EC number259-952-2
GradePh Eur,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) Nie dotyczy
Melting Point114.5 °C (rozkład)
pH value6 - 8 (100 g/l, H₂O, 20 °C)
Solubility300 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Szczur > 10000 mg/kg
Safety Information according to GHS
RTECSLW5440140
Storage class10 - 13 Inne substancje ciekłe i stałe
WGKWGK 2 znacząco zagrażający wodzie
Disposal3
Względnie niereaktywne odczynniki organiczne należy zbierać w Kategorii A. Odczynniki chlorowcowane należy umieszczać w Kategorii B. Do pozostałości stałych stosować Kategorię C.
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-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 (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)+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 %
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)≤ 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, NF, JPE
Global Trade Item Number
Numer katalogowy GTIN
1008950010 04027269161392
1008951000 04027269161415
1008959010 04027269161439

Documentation

Emprove Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sukraloza ziarnista MSDS

Title

Safety Data Sheet (SDS) 

Sukraloza ziarnista Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1008950010 Butelka szklanaDokument ze specyfikacją, w formacie PDF
1008951000 Pudelko kartonoweDokument ze specyfikacją, w formacie PDF
1008959010 Pudlo tekturoweDokument ze specyfikacją, w formacie PDF

Certificates

Title

Technical Info

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

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