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100895 Sucralose granular

Overview

Replacement Information

Key Specifications Table

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

Pricing & Availability

Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
1008950010
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      Glass bottle 10 g
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      1008950011
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          Glass bottle 10 g
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          1008951000
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              Fibre case 1 kg
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              1008951001
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                  Fibre case 1 kg
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                  1008959010
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                      Fibre carton 10 kg
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                      1008959011
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                          Fibre carton 10 kg
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                          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) Not applicable
                          Melting Point114.5 °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
                          WGKWGK 2 obviously hazardous to water
                          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
                          Global Trade Item Number
                          Catalog Number GTIN
                          1008950010 04027269161392
                          1008950011 04027269161408
                          1008951000 04027269161415
                          1008951001 04027269161422
                          1008959010 04027269161439
                          1008959011 04027269161446

                          Documentation

                          Material Qualification Dossier

                          TitleVersion
                          9.0

                          Quality Management Dossier (Open Access)

                          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
                          1008950011 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

                          Technical Info

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

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                          Categories

                          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