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阿奇霉素的杂质及制剂类型

2023.6.28

制剂

(1)阿奇霉素干混悬剂(2)阿奇霉素片3)阿奇霉素胶囊(4)阿奇霉素颗粒(5)注射用阿奇霉素

杂质

质HH3CHH3C lm OH mCh O=s=oHOH3CCH3OCH3CH3 C4H7N3O15S767.02 3′-N-[[4-(乙酰氨基)苯基]磺酸基]3′N-去甲基阿奇霉素 杂质I阿奇霉素I(3′-N-去甲基阿奇霉素)]3CCH3HOH3C lCH3H3CHOH3CCH3OCH3CH3CH C37H70N2O12734.96 (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-L26-双脱氧-3C-甲基-3-O-甲基-a-L核糖-吡喃己糖基]氧]2乙基-3,4,10三羟基-3,5,6,8,10,12,14-七甲基-11-[[3,4,6-三脱氧-3-甲氨基8-D木糖-吡喃己糖基]氧]-1-氧杂-6-氮杂环十五烷-15-酮杂质J阿奇霉素J(3O-去克拉定糖基阿奇霉素〕]H3CH3CCH3HOH3CLChCHH3CHON-CH3H3CCHaCH3(2R,3S,4R,5R,8R,10R,11R,12S,135,14R)-2-乙基3,4,10,13-四羟基-3,5,6,8,10,12,14七甲基-11-[[3,4,6三脱氧-3-二甲氨基β-D木糖吡喃己糖基]氧]-1-氧杂-6氮杂环十五烷-15-酮杂质Q(红霉素A6,9-亚胺醚)H3CHOCH3H3CH3CHOH3COOCHC3?H6N2O12730.939-去氧-6-去氧-6,9-环氧-9,9a-双脱氢-9a-氮杂高红霉素A 杂质R(红霉素A9,11-亚胺醚)MCH H3C Hn N-CH3CH3CH3CH3C3?H6N2O1714.93去氧-11-去氧-9,11-环氧9,9a-双脱氢-9a-氮杂高红霉素A杂质S(红霉素AE-肟)NOHCH3HOCH3cN-CH3一CH3OCH3CH3C3?H6N2O13748.94去氧-9-肟基红霉素


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