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130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
114.051603571602001597641586131584401594750.57
213.991559891557881558880.10
单位质量响应值RSD%判断
11350.5311142.821.31数据可信
供试品溶液-2025051921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%
5min154411-5441134.10532.687.6734.1032.687.67
246732-4673229.29229.29
348626-4862630.47930.48
452703-5270333.03433.03
552537-5253732.93032.93
657853-5785336.26236.26
10min184370-8437052.88353.226.5453.2653.586.54
275365-7536547.23947.56
383652-8365252.43352.77
489491-8949156.09356.46
585394-8539453.52553.89
691203-9120357.16657.57
15min199853-9985362.58864.075.3563.5565.035.36
295470-9547059.84060.69
397491-9749161.10762.03
4108524-10852468.02369.01
5104074-10407465.23366.19
6107931-10793167.65168.69
20min1109123-10912368.39870.556.5170.0672.216.48
2101978-10197863.92065.43
3108185-10818567.81069.41
4119595-11959574.96276.71
5120646-12064675.62177.31
6115766-11576672.56274.35
30min1123606-12360677.47679.266.1279.9081.716.09
2112321-11232170.40372.63
3127953-12795380.20182.55
4133486-13348683.66986.25
5129317-12931781.05683.58
6132029-13202982.75685.35
45min1136097-13609785.30586.445.4288.5989.775.44
2125246-12524678.50481.51
3135419-13541984.88088.13
4144080-14408090.30993.82
5140693-14069388.18691.61
6145865-14586591.42894.94
60min1138740-13874086.96288.755.3291.1993.045.33
2130133-13013381.56785.45
3139381-13938187.36491.55
4147158-14715892.23896.75
5142148-14214889.09893.50
6151955-15195595.24599.78
90min1145598-14559891.26192.294.3396.4697.574.39
2137397-13739786.12090.91
3144487-14448790.56495.72
4152601-15260195.650101.19
5148031-14803192.78698.18
6155351-15535197.374102.96
极限1139698-13969887.56390.624.3193.7796.924.36
2135584-13558484.98490.73
3144287-14428790.43996.60
4148134-14813492.85099.45
5146705-14670591.95598.38
6153063-15306395.940102.61
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130550-202401对照品来源中检所对照品使用方法直接使用
对照品含量(%)97.9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%
114.051564711569701565611572031568181568050.20
213.991555551555071555310.03
单位质量响应值RSD%判断
11160.5011117.300.28数据可信
供试品溶液-2025051921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%
5min149326-4932631.21428.518.6631.2128.518.66
239565-3956525.03725.04
342200-4220026.70526.70
447670-4767030.16630.17
548176-4817630.48630.49
643361-4336127.43927.44
10min183319-8331952.72550.775.1353.0751.085.14
273602-7360246.57646.85
376934-7693448.68548.98
483660-8366052.94153.28
580792-8079251.12651.46
683058-8305852.56052.86
15min199521-9952162.97861.543.7463.9162.423.76
294082-9408259.53660.33
392962-9296258.82759.67
4101762-10176264.39665.32
5100013-10001363.28964.20
695167-9516760.22361.11
20min1112756-11275671.35368.383.3872.9969.953.41
2103460-10346065.47166.93
3104822-10482266.33367.82
4109550-10955069.32570.96
5111027-11102770.25971.87
6106758-10675867.55869.12
30min1126702-12670280.17976.553.7182.6078.873.72
2115392-11539273.02175.21
3117935-11793574.63176.86
4125726-12572679.56181.97
5121254-12125476.73179.12
6118793-11879375.17477.48
45min1135632-13563285.83083.584.2189.1586.754.16
2122878-12287877.75980.75
3135940-13594086.02489.08
4137240-13724086.84790.14
5132539-13253983.87287.12
6128202-12820281.12884.27
60min1142585-14258590.22986.394.5794.5090.494.53
2127006-12700680.37184.23
3136291-13629186.24790.26
4143870-14387091.04395.30
5136392-13639286.31090.49
6132943-13294384.12888.17
90min1150764-15076495.40590.445.18100.6895.515.12
2131998-13199883.53088.28
3142247-14224790.01694.99
4151500-15150095.871101.14
5142479-14247990.16295.30
6138563-13856387.68492.66
极限1151115-15111595.62789.795.63101.9695.865.53
2129497-12949781.94787.63
3141780-14178089.72095.69
4150043-15004394.949101.28
5140406-14040688.85194.99
6138499-13849987.64493.60
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