依折麦布匹伐他汀钙片项目信息
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101245-202102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5000
标示量(mg)2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%
110.851286031284811286231285421283741285250.08
210.881301931298041299980.22
单位质量响应值RSD%判断
11845.6211948.350.62数据可信
供试品溶液-NB2A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%
5min1131934-13193496.11695.452.3196.1295.452.31
2127546-12754692.91992.92
3132928-13292896.84096.84
4133430-13343097.20697.21
5133404-13340497.18797.19
6126848-12684892.41192.41
10min1139787-139787101.83799.681.41102.0099.841.41
2135140-13514098.45298.61
3135043-13504398.38198.54
4136785-13678599.65099.81
5138433-138433100.851101.01
6135731-13573198.88299.04
15min1140451-140451102.32199.921.52102.65100.241.52
2135480-13548098.70099.02
3135149-13514998.45898.78
4137274-137274100.007100.33
5138645-138645101.005101.34
6135907-13590799.01199.33
20min1140216-140216102.15099.741.51102.65100.231.51
2135321-13532198.58499.07
3135337-13533798.59599.08
4136579-13657999.50099.99
5138601-138601100.973101.47
6135416-13541698.65399.14
30min1139920-139920101.93499.571.49102.60100.231.49
2135008-13500898.35699.00
3134950-13495098.31398.97
4136566-13656699.491100.15
5138299-138299100.753101.42
6135337-13533798.59599.24
45min1139196-139196101.40799.281.35102.25100.101.35
2134871-13487198.25699.07
3134799-13479998.20399.02
4136088-13608899.14299.97
5137779-137779100.374101.21
6134933-13493398.30199.11
60min1139133-139133101.36199.161.37102.37100.151.37
2134481-13448197.97298.95
3134279-13427997.82598.81
4135921-13592199.021100.01
5137389-137389100.090101.09
6135462-13546298.68699.66
极限1138701-138701101.04698.871.37102.22100.021.37
2134151-13415197.73198.87
3134106-13410697.69998.84
4135571-13557198.76699.92
5137123-13712399.897101.07
6134629-13462998.08099.22
依折麦布匹伐他汀钙片项目信息
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101245-202102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5000
标示量(mg)2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%
110.851288251285071287941287841287661287350.11
210.881294941294281294610.04
单位质量响应值RSD%判断
11864.9811898.990.21数据可信
供试品溶液-NB2A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%
5min1134116-13411697.82897.721.5897.8397.721.58
2135069-13506998.52398.52
3136975-13697599.91399.91
4131269-13126995.75195.75
5134507-13450798.11398.11
6131839-13183996.16796.17
10min1139858-139858102.016100.600.91102.18100.770.91
2138264-138264100.853101.02
3137877-137877100.571100.74
4136297-13629799.41899.58
5136859-13685999.82899.99
6138379-138379100.937101.10
15min1139533-139533101.779100.610.82102.11100.940.82
2138147-138147100.768101.10
3138001-138001100.661101.00
4136613-13661399.64999.97
5136701-13670199.713100.04
6138621-138621101.114101.44
20min1139044-139044101.422100.460.68101.92100.960.68
2137870-137870100.566101.07
3137659-137659100.412100.91
4137010-13701099.939100.43
5136416-13641699.505100.00
6138346-138346100.913101.41
30min1139063-139063101.436100.340.86102.11101.000.86
2137517-137517100.308100.98
3138320-138320100.894101.56
4136053-13605399.24099.90
5136298-13629899.419100.08
6138092-138092100.728101.39
45min1138734-138734101.196100.110.78102.04100.950.78
2137611-137611100.377101.21
3137224-137224100.095100.93
4135987-13598799.192100.02
5136079-13607999.259100.09
6137860-137860100.559101.39
60min1138724-138724101.189100.050.88102.20101.050.88
2137786-137786100.505101.51
3137273-137273100.130101.13
4135721-13572198.99899.99
5135764-13576499.030100.02
6137687-137687100.432101.43
极限1138730-138730101.19399.740.90102.37100.900.90
2136754-13675499.752100.92
3136855-13685599.825101.00
4135432-13543298.78899.94
5135461-13546198.80999.97
6137165-137165100.052101.22
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