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D230603FK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%
114.061578601573151559221557111561891565990.60
213.721522111503961513040.85
单位质量响应值RSD%判断
11137.9111027.990.71数据可信
供试品溶液-2025032622批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min150975-5097532.13633.187.9632.1433.187.96
259137-5913737.28237.28
348533-4853330.59730.60
449243-4924331.04431.04
551586-5158632.52132.52
656264-5626435.47135.47
10min179038-7903849.82849.506.7250.1949.876.70
281624-8162451.45851.87
380391-8039150.68151.02
468259-6825943.03343.38
578794-7879449.67450.04
683009-8300952.33252.73
15min191605-9160557.75158.872.9258.6659.792.96
294723-9472359.71660.70
394999-9499959.89060.79
488593-8859355.85256.67
595416-9541660.15361.07
694951-9495159.86060.84
20min1105733-10573366.65864.654.6068.2166.224.56
2103004-10300464.93766.59
399741-9974162.88064.45
495117-9511759.96561.41
5108678-10867868.51470.10
6103004-10300464.93766.58
30min1113258-11325871.40272.956.1373.6975.246.05
2114934-11493472.45874.83
3115558-11555872.85275.12
4104309-10430965.76067.87
5124605-12460578.55580.90
6121651-12165176.69379.05
45min1130626-13062682.35179.474.1285.4482.574.09
2127209-12720980.19783.37
3120649-12064976.06179.14
4118966-11896675.00077.84
5127254-12725480.22583.44
6131639-13163982.99086.20
60min1127757-12775780.54281.435.5384.5485.425.44
2136944-13694486.33490.40
3122792-12279277.41281.33
4120404-12040475.90779.58
5129327-12932781.53285.64
6137802-13780286.87591.01
90min1133935-13393584.43783.654.4189.3388.544.39
2136196-13619685.86290.89
3126373-12637379.67084.45
4125114-12511478.87683.39
5134231-13423184.62489.64
6140249-14024988.41893.52
极限1137929-13792986.95584.725.0292.7990.544.93
2141770-14177089.37695.36
3127361-12736180.29385.96
4124918-12491878.75284.15
5138801-13880187.50593.46
6135524-13552485.43991.52
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