索非布韦 中文别名:N-[[P(S),2'R]-2'-脱氧-2'-氟-2'-甲基-P-苯基-5'-尿苷酰基]-L-丙氨酸异丙酯;索菲布韦,索氟布韦 英文名称:Sofosbuvir CAS RN 1190307-88-0 分子式:C22H29FN3O9P 分子量:529.45 外观 类白色粉 干燥失重:≤1.0% 含量:98.5%-101.5% 用途:用于特定基因型慢性丙型肝炎治疗时,可消除对传统注射药物干扰素(IFN)的需求
产品名(PRODUCT NAME):N-[[P(S),2'R]-2'-Deoxy-2'-fluoro-2'-methyl-P-phenyl-5'-uridylyl] -L-alanine 1-methylethyl ester CAS No:1190307-88-0 批号(BATCH NO.)2015060601 报告日期(Report Date)2015.06.10 生产日期(Manufacturing Date)2015.06.06 复测日期(Retested Date)2016.06.05 执行标准(Perform standard): 企业标准(Enterprise standard) 分析项目 ITEM OF ANALYSIS 指标 STANDARD 分析结果 RESULT OF ANALYSIS 性状 Appearance 白色或类白色结晶性粉末 White to off-white crystalline powder 类白色结晶性粉末 white crystalline powder 鉴别Identification A.IRSimilar to reference substance Conform B.Retention TimeSimilar to reference substance Conform 溶解度Solubility Slightly soluble in water,freely soluble in ethanol and acetone, soluble in 2-propanol and insoluble in heptane Conform 晶型 (XPD) Polymorphic Identity Form 1 Form 1 粒径分布 Particle Size Distribution D(0.9)小于45um Complies 熔点Melting point 90℃~110℃ 91.6~96.6℃ 炽灼残渣 Residue on ignition ≤0.20% 0.14% 水分(卡费容量法)Wter (Volumetric Karl Fisher) ≤0.5%(ww) 0.09% 有关物质 Related substance SFBA-1≤0.15% Not Deteceted Anyother Impurity ≤0.10% 0.02% Total impurities ≤0.50% 0.08% 手性纯度Isomers ≤0.15% Not Detected 重金属Heavy metals ≤0.002% Conform 残留溶剂 Residual Solvents Acetone ≤5000ppm Not Detected Ethyl acetate ≤5000ppm Not Detected Toluene≤890nm Not Detected n-Heptane≤5000ppm Not Detected Isopropanol ≤5000ppm Not Detected Dichloromethane≤600ppm Not Detected Chlorobenzene≤360ppm Not Detected Acetic acid ≤5000ppm Not Detected Methanol ≤3000ppm Not Detected Tetrahydrofuran≤720ppm Not Detected ter-Butylmethylether≤5000ppm Not Detected 含量Assay 98.0~101.5% 99.8%
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