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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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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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              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,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
                  1008950010 04027269161392
                  1008951000 04027269161415
                  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
                  1008951000 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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                  Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Taste Modifiers