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100895 Sucralose granular

EMPROVE® ESSENTIAL Ph Eur,ChP,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,ChP,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,ChP,JPE,NF

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1008951000
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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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          Description
          Catalogue Number100895
          References
          Product Information
          CAS number56038-13-2
          EC number259-952-2
          GradePh Eur,ChP,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 (HPLC, calc. on anhydrous substance) (ChP)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/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)≥ 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, ChP, JPE, NF
          Global Trade Item Number
          Catalogue Number GTIN
          1008951000 04027269161415
          1008959010 04027269161439

          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
          1008959010 Fibre cartonPDF Specification Document

          Certificates

          Title

          Technical Info

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

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