坎地沙坦酯氨氯地平片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.757817277890780027809078340780990.22
215.767869079083788860.36
单位质量响应值RSD%判断
4958.675005.460.67数据可信
坎地沙坦酯--供试品溶液-2026042721批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119842-1984227.82629.5710.9227.8329.5710.91
220460-2046028.69228.69
319550-1955027.41627.42
424489-2448934.34234.34
10min115453-1545321.67141.3341.8521.7241.3841.80
222813-2281331.99232.04
338889-3888954.53654.58
440725-4072557.11157.17
15min139311-3931155.12856.6310.8355.2156.7510.81
243820-4382061.45161.55
334644-3464448.58348.72
443766-4376661.37661.53
20min150587-5058770.94172.753.1571.1272.963.18
252115-5211573.08473.29
350706-5070671.10871.33
454094-5409475.85976.11
30min146331-4633164.97376.5010.3165.2776.8410.30
255558-5555877.91278.24
357820-5782081.08481.42
458492-5849282.02782.41
45min157887-5788781.17882.325.9481.5882.785.93
260844-6084485.32585.78
354152-5415275.94076.41
461932-6193286.85187.37
60min165867-6586792.36993.681.3692.9194.281.41
266433-6643393.16393.76
366893-6689393.80894.41
468007-6800795.37096.03
极限163989-6398989.73596.975.2390.4397.725.24
269359-6935997.26698.02
371207-7120799.858100.61
472033-72033101.016101.84
坎地沙坦酯氨氯地平片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.757827978039780417808378159781200.13
215.767800178102780520.10
单位质量响应值RSD%判断
4960.004952.540.11数据可信
坎地沙坦酯--供试品溶液-23020201批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126546-2654637.42033.2231.5637.4233.2231.56
229526-2952641.62141.62
325490-2549035.93135.93
412711-1271117.91817.92
10min143481-4348161.29257.5717.4261.3557.6217.43
246613-4661365.70765.78
342796-4279660.32660.39
430469-3046942.95042.98
15min151643-5164372.79770.749.0172.9670.899.04
254194-5419476.39376.57
351189-5118972.15772.32
443700-4370061.60161.70
20min156560-5656079.72879.144.7180.0179.404.75
258862-5886282.97383.28
356618-5661879.81080.09
452523-5252374.03874.24
30min161825-6182587.15088.721.5087.5789.121.50
264093-6409390.34790.79
362715-6271588.40588.82
463133-6313388.99489.32
45min166534-6653493.78895.852.4594.3596.402.39
267994-6799495.84696.44
367139-6713994.64195.20
470323-7032399.12999.60
60min169282-6928297.66299.913.3598.38100.623.28
269722-6972298.28299.04
370114-7011498.83499.55
474402-74402104.879105.52
极限171894-71894101.343103.493.08102.23104.363.01
271723-71723101.102102.02
373452-73452103.540104.42
476591-76591107.964108.78
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