坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.013785237754377343823138097379340.59
216.083814237925380340.41
单位质量响应值RSD%判断
2369.392365.300.13数据可信
供试品溶液-KF021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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0001.20112.830.001.20112.78
21212-12122.8742.87
3783-7831.8571.86
41034-10342.4522.45
5-0.0000.00
6-0.0000.00
20min11433-14333.3983.3915.263.403.3915.27
21703-17034.0384.04
31423-14233.3743.38
41636-16363.8793.88
51225-12252.9052.90
61150-11502.7272.73
30min11854-18544.3964.559.264.404.559.38
22166-21665.1365.15
31786-17864.2354.24
42119-21195.0255.04
51792-17924.2494.25
61784-17844.2304.23
45min12465-24655.8455.746.545.865.766.56
22517-25175.9695.99
32239-22395.3095.33
42665-26656.3206.34
52331-23315.5285.54
62307-23075.4715.48
60min12938-29386.9676.544.286.996.564.28
22791-27916.6186.65
32734-27346.4836.51
42788-27886.6116.64
52707-27076.4196.44
62579-25796.1166.14
120min13056-30567.2476.905.127.286.945.11
23068-30687.2757.32
32667-26676.3246.36
42898-28986.8726.91
52842-28426.7396.77
62930-29306.9486.98
240min13317-33177.8667.1010.067.917.149.92
22793-27936.6236.68
33076-30767.2947.34
42504-25045.9385.99
53239-32397.6817.72
63030-30307.1857.23
极限13158-31587.4897.762.017.557.821.97
23288-32887.7977.86
33238-32387.6787.74
43324-33247.8827.94
53314-33147.8597.91
63324-33247.8827.94
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.013842438474383973875938621385350.40
216.083836938443384060.14
单位质量响应值RSD%判断
2406.932388.430.55数据可信
供试品溶液-KF021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%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1938-9382.1961.6451.982.201.6452.01
2823-8231.9271.93
3-0.0000.00
4867-8672.0302.03
5621-6211.4541.45
6966-9662.2622.26
20min11546-15463.6203.4710.853.623.4710.85
21566-15663.6673.67
31319-13193.0883.09
41482-14823.4703.47
51270-12702.9742.98
61697-16973.9733.98
30min11987-19874.6524.685.564.664.695.58
22008-20084.7014.71
31833-18334.2924.30
41977-19774.6294.64
52019-20194.7274.73
62181-21815.1075.12
45min12576-25766.0315.554.626.055.574.65
22376-23765.5635.58
32271-22715.3175.33
42384-23845.5825.60
52289-22895.3595.37
62338-23385.4745.49
60min12740-27406.4156.506.396.446.526.39
22654-26546.2146.24
32657-26576.2216.24
42612-26126.1166.14
53039-30397.1157.14
62951-29516.9096.94
120min12779-27796.5076.545.056.546.585.02
22658-26586.2236.26
32770-27706.4866.52
42655-26556.2166.25
53027-30277.0877.12
62873-28736.7276.77
240min12922-29226.8417.114.386.897.164.38
22886-28866.7576.80
33001-30017.0267.07
43122-31227.3107.36
53246-32467.6007.65
63045-30457.1297.18
极限13222-32227.5447.561.767.607.621.80
23246-32467.6007.66
33166-31667.4137.47
43179-31797.4437.50
53246-32467.6007.66
63324-33247.7837.85
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