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100894 Sukralóza, prášok

Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
1008940010 Sklená flaša 10 g
1008941000 Kartónová krabica 1 kg
1008949010 Kartónová krabica 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) Nepoužiteľné
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 Iné kvapaliny a tuhé látky
WGKWGK 2 významne ohrozuje vodné zdroje
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +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
Catalogue Number GTIN
1008940010 04027269161323
1008941000 04027269161347
1008949010 04027269161361

Documentation

Material Qualification Dossier

TitleVersion
8.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sukralóza, prášok MSDS

Title

Safety Data Sheet (SDS) 

Sukralóza, prášok Certificates of Analysis

Product Number PackagingSpecificationLot Number
1008940010 Sklená flašaPDF Specification Document
1008941000 Kartónová krabicaPDF Specification Document
1008949010 Kartónová krabicaPDF Specification Document

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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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