100894 Sucralose powder

100894
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      56038-13-2 259-952-2 C₁₂H₁₉Cl₃O₈ 397.63 g/mol Ph Eur,NF,JPE

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      1008940010
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          Glass bottle 10 g
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          1008941000
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              Fibre case 1 kg
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              1008949010
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                  Fibre carton 10 kg
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                  1008949011
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                      Fibre carton 10 kg
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                      Description
                      Catalogue Number100894
                      References
                      Product Information
                      CAS number56038-13-2
                      EC number259-952-2
                      GradePh Eur,NF,JPE
                      Hill FormulaC₁₂H₁₉Cl₃O₈
                      Molar Mass397.63 g/mol
                      HS Code2932 14 00
                      Structure formula ImageStructure formula Image
                      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)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)+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)≤ 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, NF, JPE

                      Documentation

                      Material Qualification Dossier

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                      Quality Management Dossier

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                      Operational Excellence Dossier

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                      Sucralose powder SDS

                      Title

                      Safety Data Sheet (SDS) 

                      Sucralose powder Certificates of Analysis

                      Product Number PackagingSpecificationLot Number
                      1008940010 Glass bottlePDF Specification Document
                      1008941000 Fibre casePDF Specification Document
                      1008949010 Fibre cartonPDF Specification Document
                      1008949011 Fibre cartonPDF Specification Document

                      Certificates

                      Title