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%
110.851281141280471283081282811282311281960.09
210.881287551287791287670.02
单位质量响应值RSD%判断
11815.3011835.200.12数据可信
供试品溶液-NB2A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%
5min1126522-12652292.73195.291.7392.7395.291.73
2130828-13082895.88795.89
3131465-13146596.35496.35
4132976-13297697.46197.46
5129173-12917394.67494.67
6129108-12910894.62694.63
10min1132568-13256897.16297.870.7597.3298.030.75
2133552-13355297.88398.04
3133150-13315097.58997.75
4135383-13538399.22599.39
5133701-13370197.99398.15
6132872-13287297.38597.54
15min1132484-13248497.10197.741.0297.4298.061.01
2133077-13307797.53597.86
3132855-13285597.37397.70
4135606-13560699.38999.72
5134210-13421098.36698.69
6131876-13187696.65596.98
20min1132121-13212196.83597.840.9397.3198.320.93
2133577-13357797.90298.39
3132966-13296697.45497.94
4135574-13557499.36599.86
5134086-13408698.27598.76
6132635-13263597.21197.69
30min1132388-13238897.03097.620.7597.6798.260.75
2132925-13292597.42498.07
3132515-13251597.12397.77
4134969-13496998.92299.58
5133706-13370697.99698.65
6132616-13261697.19797.84
45min1131207-13120796.16597.380.9596.9798.200.95
2132123-13212396.83697.65
3132843-13284397.36498.17
4134759-13475998.76899.59
5133785-13378598.05498.87
6132504-13250497.11597.92
60min1130556-13055695.68896.981.2696.6597.951.25
2132526-13252697.13198.10
3130730-13073095.81596.79
4135073-13507398.99899.99
5132933-13293397.43098.41
6132088-13208896.81097.78
极限1131928-13192896.69397.090.9897.8198.220.98
2132325-13232596.98498.12
3131252-13125296.19897.33
4134688-13468898.71699.87
5133167-13316797.60198.74
6131424-13142496.32497.45
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%
110.851287571288211288691288651286751287970.07
210.881304541302371303460.12
单位质量响应值RSD%判断
11870.6911980.330.66数据可信
供试品溶液-NB2A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%
5min1130644-13064494.94992.961.4294.9592.971.42
2126073-12607391.62791.63
3125991-12599191.56791.57
4128083-12808393.08893.09
5129201-12920193.90093.90
6127491-12749192.65792.66
10min1133330-13333096.90196.800.5897.0696.960.59
2133126-13312696.75396.91
3131763-13176395.76295.91
4133215-13321596.81896.97
5133750-13375097.20697.36
6133964-13396497.36297.52
15min1134085-13408597.45096.890.6397.7797.210.63
2132344-13234496.18596.50
3132213-13221396.08996.40
4133740-13374097.19997.52
5133991-13399197.38297.70
6133538-13353897.05297.37
20min1132813-13281396.52596.910.6797.0197.390.67
2133349-13334996.91597.39
3131919-13191995.87696.35
4133555-13355597.06597.54
5134117-13411797.47397.95
6134333-13433397.63098.11
30min1132507-13250796.30396.820.9296.9597.460.91
2132730-13273096.46597.10
3131441-13144195.52896.16
4133802-13380297.24497.88
5134081-13408197.44798.09
6134767-13476797.94698.59
45min1133014-13301496.67196.590.6897.4897.390.68
2132266-13226696.12896.92
3131398-13139895.49796.29
4133601-13360197.09897.90
5133375-13337596.93497.74
6133725-13372597.18897.99
60min1133814-13381497.25396.460.8398.2297.420.83
2132637-13263796.39797.35
3131026-13102695.22796.18
4132964-13296496.63597.60
5132008-13200895.94096.91
6133905-13390597.31998.29
极限1131597-13159795.64296.000.7896.7797.130.77
2131892-13189295.85696.97
3130697-13069794.98896.10
4132287-13228796.14397.27
5132298-13229896.15197.28
6133794-13379497.23898.37
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