他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源欧洲对照品使用方法直接使用
对照品含量(%)97.8对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.873237532296321853212532199322360.31
213.613212432184321540.14
单位质量响应值RSD%判断
2324.152362.531.16数据可信
供试品溶液-24110101批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115861-1586147.66547.1710.4847.6647.1710.48
216975-1697551.01251.01
316914-1691450.82950.83
417114-1711451.43051.43
513484-1348440.52140.52
613836-1383641.57941.58
10min122971-2297169.03162.467.6269.5662.997.59
218811-1881156.53057.10
321815-2181565.55766.12
421599-2159964.90865.48
519853-1985359.66160.11
619662-1966259.08759.55
15min125046-2504675.26774.163.5776.5675.383.47
223441-2344170.44471.64
323783-2378371.47172.76
425014-2501475.17176.46
525758-2575877.40678.52
625022-2502275.19576.31
20min128496-2849685.63578.585.3687.7780.625.30
224383-2438373.27475.25
325711-2571177.26579.35
426865-2686580.73382.86
525928-2592877.91779.89
625507-2550776.65278.61
30min129687-2968789.21488.413.5892.3091.323.54
227797-2779783.53486.33
330670-3067092.16895.11
429658-2965889.12792.15
530120-3012090.51593.35
628577-2857785.87888.68
45min131398-3139894.35595.163.5698.4399.063.52
229975-2997590.07993.80
333184-3318499.723103.69
432569-3256997.874101.89
531728-3172895.34799.19
631141-3114193.58397.34
60min133915-33915101.91999.262.78107.04104.222.67
232818-3281898.623103.34
333510-33510100.702105.78
431619-3161995.020100.12
533907-33907101.895106.80
632416-3241697.415102.21
90min133273-3327399.99097.991.93106.25104.041.96
231437-3143794.473100.29
332956-3295699.037105.23
432645-3264598.103104.26
532540-3254097.787103.82
632788-3278898.533104.41
极限133120-3312099.53098.544.19106.90105.684.05
231278-3127893.995100.86
335248-35248105.925113.22
432571-3257197.881105.13
532697-3269798.259105.38
631819-3181995.621102.60
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