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%
1 14.111655831654901651461648891648281651870.21
2 14.171648071649191648630.05
单位质量响应值RSD%判断
11707.0911634.650.44数据可信
供试品溶液-24111101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%
5min155840-5584033.42933.323.5433.4333.323.54
252834-5283431.63031.63
356441-5644133.78933.79
458790-5879035.19635.20
554798-5479832.80632.81
655264-5526433.08533.08
10min179646-7964647.68148.022.4648.0548.392.46
276654-7665445.89046.24
382280-8228049.25849.63
481526-8152648.80749.20
580759-8075948.34848.71
680397-8039748.13148.50
15min193272-9327255.83955.862.4856.7456.762.46
291498-9149854.77755.64
397811-9781158.55659.48
491734-9173454.91855.85
592836-9283655.57856.48
692644-9264455.46356.37
20min1104103-10410362.32362.062.0763.8463.582.03
2101615-10161560.83362.30
3102052-10205261.09562.67
4104691-10469162.67564.22
5102227-10222761.20062.72
6107256-10725664.21065.73
30min1118758-11875871.09671.922.6673.3174.132.59
2119559-11955971.57673.72
3125567-12556775.17377.42
4116579-11657969.79272.03
5118379-11837970.86973.07
6121924-12192472.99275.22
45min1130755-13075578.27979.461.6781.2882.471.63
2132469-13246979.30582.25
3136234-13623481.55984.65
4131026-13102678.44181.46
5134541-13454180.54583.53
6131315-13131578.61481.66
60min1138925-13892583.17083.621.8187.0487.511.80
2136786-13678681.88985.71
3144148-14414886.29690.29
4138032-13803282.63586.52
5140081-14008183.86287.74
6140050-14005083.84387.76
90min1145067-14506786.84786.571.9891.6491.401.94
2139824-13982483.70888.44
3147829-14782988.50093.45
4146736-14673687.84692.65
5143014-14301485.61890.43
6145168-14516886.90791.76
极限1144114-14411486.27685.452.1992.0491.242.14
2138781-13878183.08388.75
3148045-14804588.62994.57
4142459-14245985.28591.07
5141528-14152884.72890.49
6141519-14151984.72390.54
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%
1 14.111647921659151662701661201664851659160.40
2 14.171655371652871654120.11
单位质量响应值RSD%判断
11758.7511673.390.52数据可信
供试品溶液-24111102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%
5min153412-5341231.85332.084.5131.8532.084.52
251218-5121830.54430.54
350949-5094930.38430.38
456670-5667033.79633.80
556260-5626033.55133.55
654212-5421232.33032.33
10min179762-7976247.56747.312.6247.9247.672.63
276022-7602245.33645.68
377669-7766946.31946.66
480909-8090948.25148.63
580277-8027747.87448.25
681388-8138848.53648.90
15min194228-9422856.19456.832.5457.0857.712.54
291446-9144654.53555.38
394743-9474356.50157.35
495960-9596057.22758.14
597020-9702057.85958.76
698363-9836358.66059.56
20min1116605-11660569.53864.404.7471.0565.924.66
2101685-10168560.64162.09
3104597-10459762.37763.86
4106764-10676463.67065.22
5108461-10846164.68266.23
6109830-10983065.49867.05
30min1118876-11887670.89371.573.2473.1773.803.20
2112946-11294667.35669.48
3121671-12167172.55974.73
4124352-12435274.15876.41
5120793-12079372.03674.30
6121420-12142072.41074.69
45min1133306-13330679.49878.452.5882.5781.472.58
2124698-12469874.36577.24
3132552-13255279.04882.03
4133536-13353679.63582.71
5132948-13294879.28582.35
6132205-13220578.84181.92
60min1134118-13411879.98281.912.9083.9385.812.86
2131153-13115378.21481.91
3137853-13785382.21086.07
4141402-14140284.32688.29
5140583-14058383.83887.79
6139028-13902882.91086.87
90min1140073-14007383.53484.614.2588.3789.414.15
2130405-13040577.76882.33
3144118-14411885.94690.72
4145561-14556186.80691.71
5144926-14492686.42891.31
6146148-14614887.15792.04
极限1137858-13785882.21383.541.9387.9889.281.96
2136364-13636481.32286.75
3139590-13959083.24688.97
4142385-14238584.91290.78
5140789-14078983.96189.80
6143474-14347485.56291.41
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