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100894 Sucralose powder

EMPROVE® ESSENTIAL Ph Eur,ChP,NF,JPE

Sucralose powder 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,NF,JPE
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100894
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개요

Replacement Information

주요 사양표

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

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1.00894.0010
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      		 Glass bottle 10 g
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          		 Fibre carton 1 kg
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          Description
          Catalogue Number100894
          References
          Product Information
          CAS number56038-13-2
          EC number259-952-2
          GradePh Eur,ChP,NF,JPE
          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)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/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)≤ 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, ChP, NF, JPE
          Global Trade Item Number
          카탈로그 번호 GTIN
          1.00894.0010 04027269161323
          1.00894.1000 04027269161347

          Documentation

          Material Qualification Dossier

          TitleVersion
          8.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Sucralose powder MSDS

          타이틀

          물질안전보건자료(MSDS) 

          Sucralose powder Certificates of Analysis

          제품 번호 패킹스펙로트(lot) 번호
          1.00894.0010 Glass bottlePDF 사양 문건
          1.00894.1000 Fibre cartonPDF 사양 문건

          Certificates

          Title

          Brochure

          Title
          Two ways to ace the taste test

          관련 제품 및 어플리케이션

          관련 제품: Application Facete

          Taste Modifiers

          관련 제품: Brand Facete

          EMPROVE®

          카테고리

          Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid
          Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Sweeteners
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Taste Modifiers
          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Taste Modifiers
          Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Taste Modifiers