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  • Sucralose


    Product  Name: SUCRALOSE
                   

    Chemical Name:1’,6’–Dichloro-1’,  6’–dideoxy–β–D-fructofuranosyl–4–chloro–4– deoxy–α–D-galactopyranoside                   

    Chemical formula:C12H19  Cl3O8

    Molecular Weight: 397.64       CAS :  [56038-13-2]
       
    Identification:
       
       
    A:  The infrared absorption spectrum of a potassium bromide dispersion of the Product  exhibits relative maxima at the same  wavelengths as those of a similar preparation of Sucralose Standard  for analytical use.
      B:  There tension time of the major  peak in the liquid chromatogram of the Product Preparation is the same as that of the Standard Preparation obtained in the Assay.
      C:  The Rf value of the major spot in the thin-layer chromatogram of the Product Preparation is the same as that of the Standard Preparation obtained in the test for Related Substances.
       
    Character: A white to off-white powder; odorless and without unpleasant  aftertaste, stable to heat, light and acids; freely soluble in water, ethanol  and methanol; slightly soluble in ethyl acetate.
                                                             
                   

                                  ITEM                                     STANDARD            
    Appearance             White  crystalline powder            
    Assay(on dry basis)  (%)             98.0-102.0            
    PH (10% aqucous  solution)             5.0-7.0            
    Specific rotation            +84.0°~+87.5°            
    Moisture (%)            ≤2.0            
    Methanol (%)            ≤0.1            
    Arsenic(as As)             ≤0.0003%            
    Heavy metals             ≤0.001%            
    Ignited Residue            ≤0.7%            
    Lead (mg/kg)             ≤1.0            
    Hydrolysis Products/ Chlorinated monosaccharides            ≤0.1%            
    Related Substances/ Other chlorinated disaccharides            <0.5%            
    Triphenylphosphine Oxide            ≤150mg/kg            
                                             MICROBIOLOGICAL REQUIREMENTS            
    Total Aerobic Count            ≤250cfu/g            
    Yeasts/Molds            ≤50cfu/g            
    Coliform            <10cfu/g            
    E.Coli             Negative            
    S. Aureus            Negative            
    Salmonella            Negative            

    Conclusion: The quality in conformity with FCC(VI)/USP/NF/EC(E955). The product is manufactured in accordance with GMP standards.

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