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对乙酰氨基酚片一致性评价项目报价及评价方案1

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杂质不得大于0.1%.Р干燥失重Р减失重量不得过0.5%Р不得过0.5%Р不得过0.5%Р重金属Р不得过百万分之十Р不得过20ppmР不得过0.001%Р炽灼残渣Р不得过0.1%Р不得过0.1%Р不得过0.1%Р含量测定Р分光光度法,不得少于98.0%-102.0%Р滴定法,99.0-101.0%Р滴定法,99.0-101.0%Р杂质列РA. R1 = R3 = R4 = H, R2 = OH: N-(2-hydroxyphenyl)-Р表Рacetamide,РB. R1 = CHР3, R2 = R3 = H, R4 = OH: N-(4-Рhydroxyphenyl)propanamide,РC. R1 = R2 = H, R3 = Cl, R4 = OH: N-(3-chloro-4-Рhydroxyphenyl)acetamide,РD. R1 = R2 = R3 = R4 = H: N-phenylacetamide,РH. R1 = R2 = R3 = H, R4 = O-CO-CH3: 4-(acetylamino)phenylРacetate,РJ. R1 = R2 = R3 = H, R4 = Cl: N-(4-chlorophenyl)acetamideР(chloroacetanilide),РE. X = O, R2 = H, R4 = OH: 1-(4-hydroxyphenyl)ethanone,РG. X = N-OH, R2 = H, R4 = OH: 1-(4-hydroxyphenyl)ethanoneРoxime,РI. X = O, R2 = OH, R4 = H: 1-(2-hydroxyphenyl)ethanone,РF. R = NOР2: 4-nitrophenol,РK. R = NHР2: 4-aminophenol.

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