Product Information
Applications
Biological Information
Physicochemical Information
Density1.62 g/cm3 (20 °C) Not applicable
Melting Point130 °C (decomposition)
pH value6 - 8 (100 g/l, H₂O, 20 °C)
Solubility300 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat > 10000 mg/kg
Safety Information according to GHS
RTECSLW5440140
Storage class10 - 13 Other liquids and solids
WGKNWG not water endangering
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
StorageStore at +15°C to +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

Documentation

Material Qualification Dossier

Title

Quality Management Dossier

Title

Operational Excellence Dossier

Title

Sucralose granular SDS

Title

Safety Data Sheet (SDS) 

Sucralose granular Certificates of Analysis

Product Number PackagingSpecificationLot Number
1008950010 Glass bottlePDF Specification Document
1008951000 Fibre casePDF Specification Document
1008951001 Fibre casePDF Specification Document
1008959010 Fibre cartonPDF Specification Document
1008959011 Fibre cartonPDF Specification Document

Certificates

Title

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Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid