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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 Specifications Table

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

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1008950010
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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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          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
              Catalog Number GTIN
              1008950010 04027269161392
              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
              1008950010 Glass bottlePDF Specification Document
              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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