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100895 Sucralose granular

EMPROVE® ESSENTIAL Ph Eur,JPE,NF

Sucralose granular 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
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100895
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Overview

Replacement Information

Key Spec Table

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

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1008951000
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      		 Fibre case 1 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
      Catalogue Number GTIN
      1008951000 04027269161415

      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
      1008951000 Fibre casePDF Specification Document

      Certificates

      Title

      Technical Info

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

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