January 12, 2018
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Shandong Binzhou Zhiyuan biological cooperation with Shandong University production sulfobutyl betacyclodextrin, Shandong University is a university research China cyclodextrin more professional, sulfobutyl times our betacyclodextrin process is further optimized, the quality of the Chinese is the most excellent products, mainly in the chromaticity, turbidity, clarity, impurity, the degree of substitution. The product clarity is very good, there is no smell, far better than other domestic products; low impurity content, much lower than the USP39 standard, as he determination of zero, 1,4 butane sultone, 4- hydroxy -1- butane sulfonic acid (4- acid, two Ding Ji two) ether sodium has been able to do is very low, almost no; degree of substitution concentration, a substitution degree is zero, the degree of substitution of accurate control, the provisions of USP39 with degree of substitution for 6.2-6.9, our basic control at 6.4-6.6; the products of our company and American products branded company done, basically no difference.
Sodium sulfonyl ether cyclodextrin sodium salt has obtained the state "drug registration application notification" accepted CXFS1500004 Lu. To obtain clinical approval of drugs: 2016L06918. Sulfonyl dicyclodextrin is in conformity with the standard requirements of the United States Food and Drug Administration (FDA), and has been approved for registration, and the DMF record number: 030167
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