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%
110.851317211318921319031316691315311317430.12
210.881327581327031327300.03
单位质量响应值RSD%判断
12142.2112199.450.34数据可信
供试品溶液-24021801批-匹伐他汀钙-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%
5min1131791-13179193.85189.846.1593.8589.846.15
2125830-12583089.60689.61
3129355-12935592.11692.12
4131172-13117293.41093.41
5127795-12779591.00591.00
6110981-11098179.03179.03
10min1140136-14013699.79397.472.1399.9597.622.14
2136885-13688597.47897.63
3136617-13661797.28797.44
4139164-13916499.10199.26
5136685-13668597.33697.49
6131752-13175293.82393.95
15min1139651-13965199.44897.561.9199.7797.871.92
2136368-13636897.11097.42
3136562-13656297.24897.56
4139766-13976699.53099.85
5136996-13699697.55797.87
6132650-13265094.46294.75
20min1139882-13988299.61297.352.24100.1097.822.25
2136265-13626597.03797.51
3136270-13627097.04097.52
4139554-13955499.37999.87
5136826-13682697.43697.91
6131410-13141093.57994.02
30min1139087-13908799.04697.401.9199.7098.041.91
2136305-13630597.06597.70
3136596-13659697.27297.91
4139448-13944899.30399.96
5137018-13701897.57398.21
6132192-13219294.13694.74
45min1138514-13851498.63897.171.6899.4697.971.69
2136169-13616996.96897.77
3136136-13613696.94597.75
4138959-13895998.95599.77
5136423-13642397.14997.95
6132540-13254094.38495.14
60min1138845-13884598.87496.841.9399.8697.801.94
2135158-13515896.24897.21
3136157-13615796.96097.92
4138327-13832798.50599.49
5135890-13589096.76997.73
6131534-13153493.66894.58
极限1138655-13865598.73996.731.9499.8997.851.94
2135572-13557296.54397.66
3135774-13577496.68797.81
4138393-13839398.55299.70
5135155-13515596.24697.37
6131433-13143393.59694.67
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.003795813798583802003800773797283798890.07
210.933784623792453788540.15
单位质量响应值RSD%判断
34535.3634661.850.26数据可信
供试品溶液-24021801批-依折麦布-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%
5min123340-233406.0715.977.436.075.977.42
223239-232396.0456.05
324011-240116.2466.25
423719-237196.1706.17
523844-238446.2026.20
619518-195185.0775.08
10min137879-378799.8539.562.889.869.572.88
236411-364119.4719.48
337809-378099.8359.85
437045-370459.6369.65
536146-361469.4039.41
635130-351309.1389.15
15min137219-372199.6829.822.189.719.852.16
237722-377229.8139.84
338897-3889710.11810.14
438621-3862110.04610.07
536934-369349.6089.63
637151-371519.6649.69
20min138932-3893210.1279.703.1110.179.743.10
236360-363609.4589.50
338237-382379.9469.99
437408-374089.7319.77
536994-369949.6239.67
635828-358289.3209.36
30min137629-376299.7889.682.689.859.742.71
236771-367719.5659.62
338348-383489.97510.04
437941-379419.8699.93
537087-370879.6479.71
635548-355489.2479.30
45min137034-370349.6349.661.799.719.731.79
236917-369179.6039.68
338388-383889.98610.06
437120-371209.6569.73
536944-369449.6109.68
636400-364009.4699.54
60min136752-367529.5609.482.609.659.562.57
235961-359619.3549.44
338179-381799.93110.02
436080-360809.3859.48
536052-360529.3789.47
635530-355309.2429.33
极限137302-373029.7039.641.899.819.751.90
237789-377899.8309.94
337761-377619.8239.93
437043-370439.6369.74
536466-364669.4869.59
636061-360619.3809.48
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