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三氯蔗糖



产品名:三氯蔗糖
    
化学名:  4,1',6'-trichlorogalactosucrose;1,6–Dichloro-1,6–dideoxy–β–D-fructofuranosyl–4–chloro–4–

   deoxy–α–D–galactopyranoside


化学式:C12H19 Cl3O8              分子量: 397.64            CAS :  [56038-13-2]


Identification:

     

  • A:The infrared absorption spectrum of a potassium bromide dispersion of the Product exhibitsrelative maxima at the same wave lengths as those of a similar preparation of Sucralose Standard for analytical use.

  • B:The retention 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 inthe test for Related Substances.   


  • 性状:白色至类白色粉末;无臭,对热,光和酸稳定;易溶于水,乙醇和甲醇;微溶于乙酸乙酯。                                                                                                              

                参数               标准值              检测方法
外观白色结晶粉末GB 25531-2010
含量(%)98.0-102.0FCCⅧ
PH值5.0– 7.0EC(E955)
旋光率 [α]D20+84.0°~ +87.5°USP-NF
水分,(%)≤2.0USP-NF
甲醇 (%)≤0.1FCCⅧ
砷(as pb),(mg/kg)≤3GB/T 5009.76
重金属(as Pb),(mg/kg)≤10USP-NF
三苯基氧膦,(mg/kg)≤150EC(E955)
灰分,(%)≤0.7USP-NF
铅(as As),(mg/kg)≤1EP7.2
氯化单糖,(%)≤0.1FCCⅧ
氯化双糖,(%)≤0.5FCCⅧ
                                                                 微生物要求
总菌数≤250cfu/gUSP<2021>
酵母菌/霉菌≤50cfu/gUSP<2021>
大肠杆菌≤10cfu/gUSP<2021>
金黄色葡萄球菌≤10cfu/gUSP<2021>
沙门氏菌Negative/25gUSP<2021><2022>

                           

质量要求符合 FCCⅧ/USP/NF/EC(E955)/EP7.2/GB25531. 产品生产符合GMP标准

                                                                                       

                             


 


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