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100894 Sucraloza pulbere,

EMPROVE® ESSENTIAL Ph Eur,ChP,NF,JPE

Sucraloza pulbere, 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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Replacement Information

Key Spec Table

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

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          1008949010
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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) Nu se aplică
              Melting Point114.5 °C (descompunere)
              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 Alte lichide sau solide
              WGKWGK 2 substanţe cu potenţial specific de poluare a apei
              Disposal3
              Reactivii organici relativ cu reactivitate relativ redusa trebuie colectati in containerul A. Daca sunt halogenati, ei trebuie colectati in containerul B. Pentru reziduurile solide utilizati containerul C.
              Safety Information
              Product Usage Statements
              Storage and Shipping Information
              StorageA se depozita între +15°C la +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
              Catalogue Number GTIN
              1008940010 04027269161323
              1008941000 04027269161347
              1008949010 04027269161361

              Documentation

              Emprove Dossier

              TitleVersion
              8.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Sucraloza pulbere, MSDS

              Title

              Safety Data Sheet (SDS) 

              Sucraloza pulbere, Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1008940010 Glass bottlePDF Specification Document
              1008941000 Fibre cartonPDF Specification Document
              1008949010 Fibre cartonPDF Specification Document

              Certificates

              Title

              Brochure

              Title
              Two ways to ace the taste test

              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