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          1. 三氯蔗糖



            產品名:三氯蔗糖
                
            化學名:  4,1',6'-trichlorogalactosucrose;1,6–Dichloro-1,6–dideoxy–β–D-fructofuranosyl–4–chloro–4–

               deoxy–α–D–galactopyranoside


            化學式: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.   


            • 性狀:白色至類白色粉末;無臭,對熱,光和酸穩定;易溶于水,乙醇和甲醇;微溶于乙酸乙酯。                                                                                                              

                            參數               標準值              檢測方法
            外觀白色結晶粉末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
            重金屬(as Pb),(mg/kg)≤10USP-NF
            三苯基氧膦,(mg/kg)≤150EC(E955)
            灰分,(%)≤0.7USP-NF
            鉛(as As),(mg/kg)≤1EP7.2
            氯化單糖,(%)≤0.1FCCⅧ
            氯化雙糖,(%)≤0.5FCCⅧ
                                                                             微生物要求
            總菌數≤250cfu/gUSP<2021>
            酵母菌/霉菌≤50cfu/gUSP<2021>
            大腸桿菌≤10cfu/gUSP<2021>
            金黃色葡萄球菌≤10cfu/gUSP<2021>
            沙門氏菌Negative/25gUSP<2021><2022>

                                       

            質量要求符合 FCCⅧ/USP/NF/EC(E955)/EP7.2/GB25531. 產品生產符合GMP標準

                                                                                                   

                                         


             


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