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Fenofibrat - FENOFIBRAT Fenofibratum C20H21ClO4 P.t.l 360,8...

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FENOFIBRAT Fenofibratum C 20 H 21 ClO 4 P.t.l: 360,8 Fenofibrat là 1-methylethyl 2-[4-(4-clorobenzoyl) phenoxy]-2-methylpropanoat, ph i ch a t 98,5 đ n 101,0% C ế 20 H 21 ClO 4 , tính theo ch ph m đã làm khô. ế Tính ch t B t k t tinh màu tr ng ho c g n nh tr ng. ế ư Th c t không tan trong n c, r t d tan trong methylen clorid, khó tan trong ethanol 96%. ế ướ Đ nh tính A. Ph h ng ngo i (Ph l c 4.2) c a ch ph m ph i phù h p v i ph h ng ngo i c a ế fenofibrat chu n (ĐC) . B. Đi m ch y (Ph l c 6.7): 79 đ n 82 ụ ụ ế ° C Đ trong và màu s c c a dung d ch Dung d ch S: Hoà tan 5,0 g ch ph m trong 25 ml n c c t và làm nóng 50 ế ướ o C trong 10 phút. Đ ngu i và pha loãng thành 50,0 ml v i n c c t. L c. D ch l c là dung d ch S. ướ Hoà tan 0,50 g ch ph m trong ế aceton (TT) và pha loãng thành 10,0 ml v i cùng dung môi. Dung d ch ph i trong (Ph l c 9.2) và không đ c đ m màu h n màu c a màu m u VN ượ ơ 6 ( Ph l c 9.3, ph ng pháp 2). ụ ụ ươ Gi i h n acid Hoà tan 1,0 g ch ph m trong 50 ml ế ethanol 96% ( TT) đã đ c trung hoà tr c v i ch th là ượ ướ 0,2 ml dung d ch phenolphtalein (TT) . Dung d ch s chuy n sang màu h ng khi thêm không quá 0,2 ml dung d ch natri hydroxyd 0,1M (CĐ) T p ch t liên quan Ph ng pháp s c ký l ng (Ph l c 5.3) ươ ụ ụ Đi u ki n s c ký và các dung d ch nh mô t trong ph n đ nh l ng, nh ng th tích tiêm: 20 ư ượ ư μ l Cách ti n hành:
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