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%
114.191637391634271633601628921631501633140.20
214.111634691634001634340.03
单位质量响应值RSD%判断
11509.0911582.850.46数据可信
供试品溶液-24070801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%
5min153326-5332632.52331.663.2832.5231.663.28
252045-5204531.74131.74
352614-5261432.08832.09
453785-5378532.80232.80
549780-4978030.36030.36
649940-4994030.45730.46
10min175320-7532045.93645.314.4746.3045.664.46
277024-7702446.97647.33
374810-7481045.62545.98
477796-7779647.44647.81
571730-7173043.74744.08
669059-6905942.11842.46
15min188908-8890854.22353.795.5955.1054.645.55
290439-9043955.15756.03
385101-8510151.90252.76
496370-9637058.77459.67
585997-8599752.44853.27
682327-8232750.21051.02
20min199756-9975660.83960.114.5262.3161.564.51
2100935-10093561.55863.05
393576-9357657.07058.51
4105647-10564764.43265.98
596359-9635958.76860.17
695095-9509557.99759.36
30min1113642-11364269.30868.564.5771.4670.684.56
2113364-11336469.13971.31
3109345-10934566.68768.76
4121627-12162774.17876.44
5108603-10860366.23568.29
6107882-10788265.79567.80
45min1123478-12347875.30775.634.6078.2378.524.57
2122399-12239974.64977.59
3123038-12303875.03977.85
4135186-13518682.44785.53
5120817-12081773.68476.48
6119160-11916072.67375.41
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%
114.191630351628321627011627291627431628080.09
214.111646621647091646860.03
单位质量响应值RSD%判断
11473.4311671.581.22数据可信
供试品溶液-24070901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%
5min155583-5558333.82341.0710.5233.8241.0710.52
268522-6852241.69741.70
372411-7241144.06444.06
472437-7243744.07944.08
562512-6251238.04038.04
673450-7345044.69644.70
10min178539-7853947.79356.699.5848.1757.159.59
296869-9686958.94759.41
397969-9796959.61660.11
4100647-10064761.24661.74
585762-8576252.18852.61
699190-9919060.35960.86
15min194311-9431157.39067.269.1658.3068.349.17
2116216-11621670.72071.84
3116100-11610070.64971.80
4114665-11466569.77670.95
5101755-10175561.92062.92
6120103-12010373.08574.25
20min1102660-10266062.47172.668.7864.0274.508.79
2125613-12561376.43878.34
3125744-12574476.51878.45
4127593-12759377.64379.59
5109849-10984966.84568.54
6124969-12496976.04678.03
30min1114856-11485669.89282.589.6872.1385.229.67
2143290-14329087.19589.95
3145013-14501388.24391.03
4143541-14354187.34890.16
5123405-12340575.09577.53
6144148-14414887.71790.54
45min1125731-12573176.51088.388.5079.5391.948.53
2151539-15153992.21595.94
3153746-15374693.55897.33
4154905-15490594.26398.04
5133731-13373181.37884.65
6151728-15172892.33096.13
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