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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
1 13.952919029205290252903529020290950.33
213.712829328194282440.25
单位质量响应值RSD%判断
2085.662060.100.88数据可信
供试品溶液-123640批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min111389-1138938.38938.636.0838.3938.636.09
211021-1102137.14937.15
312210-1221041.15741.16
410336-1033634.84034.84
511991-1199140.41940.42
611808-1180839.80239.80
10min117520-1752059.05556.723.9959.4857.153.94
217105-1710557.65658.07
316649-1664956.11956.58
417027-1702757.39457.78
515581-1558152.51952.97
617089-1708957.60358.04
15min120441-2044168.90166.783.4269.9867.843.39
220363-2036368.63869.69
319901-1990167.08168.16
419186-1918664.67165.70
518793-1879363.34664.38
620194-2019468.06969.15
20min121908-2190873.84672.825.4175.6974.625.30
221638-2163872.93674.75
321655-2165572.99374.82
422761-2276176.72178.46
519385-1938565.34267.08
622273-2227375.07676.92
30min126437-2643789.11285.346.6291.7887.946.48
226490-2649089.29191.92
325605-2560586.30888.94
426738-2673890.12792.72
522519-2251975.90678.37
624110-2411081.26983.94
45min129254-2925498.60891.375.48102.2794.935.38
227996-2799694.36797.99
327789-2778993.66997.27
426394-2639488.96792.56
525345-2534585.43188.74
625864-2586487.18190.76
60min128909-2890997.44593.353.82102.2097.933.80
228677-2867796.663101.33
328081-2808194.65499.29
426827-2682790.42795.01
526217-2621788.37192.63
627458-2745892.55497.10
90min128260-2826095.25791.366.61101.0996.986.42
228112-2811294.758100.50
328320-2832095.459101.15
426397-2639788.97794.57
523755-2375580.07285.31
627788-2778893.66699.24
极限125145-2514584.75786.217.0391.6592.846.59
226824-2682490.41797.21
326775-2677590.25297.00
422268-2226875.06081.64
525462-2546285.82691.95
626989-2698990.97397.59
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D230603对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
1 13.953038930421301383025930029302470.55
213.713020830126301670.20
单位质量响应值RSD%判断
2168.242200.361.04数据可信
供试品溶液-123640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%
5min110956-1095635.04737.238.0235.0537.238.02
211358-1135836.33336.33
310542-1054233.72233.72
411786-1178637.70237.70
513207-1320742.24742.25
611984-1198438.33538.33
10min116210-1621051.85356.766.6752.2457.186.67
217519-1751956.04156.44
316696-1669653.40853.78
418714-1871459.86360.28
519318-1931861.79562.26
618014-1801457.62458.05
15min121227-2122767.90267.855.9968.8768.905.98
221233-2123367.92168.95
319411-1941162.09363.06
421852-2185269.90170.99
523144-2314474.03475.19
620400-2040065.25766.32
20min123753-2375375.98274.514.7777.7076.314.78
223324-2332474.61076.39
321486-2148668.73070.39
423559-2355975.36277.22
524831-2483179.43181.41
622806-2280672.95374.74
30min124960-2496079.84382.684.0682.4185.314.10
226464-2646484.65487.26
324427-2442778.13880.56
425954-2595483.02385.72
527365-2736587.53690.40
625916-2591682.90185.50
45min128348-2834890.68190.013.3294.1393.563.37
228274-2827490.44493.99
326819-2681985.79089.08
428024-2802489.64593.27
529668-2966894.90398.74
627704-2770488.62192.14
60min128849-2884992.28490.593.7896.7495.133.80
228222-2822290.27894.83
326777-2677785.65689.90
428487-2848791.12695.74
529925-2992595.726100.61
627656-2765688.46792.98
90min128694-2869491.78891.853.7397.2797.403.74
228417-2841790.90296.46
327133-2713386.79491.99
428362-2836290.72696.35
530322-3032296.995102.95
629356-2935693.90599.40
极限129494-2949494.34791.193.79100.8597.763.73
228917-2891792.50199.07
327201-2720187.01293.17
428750-2875091.96798.60
529532-2953294.468101.50
627147-2714786.83993.37
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