氨氯地平阿托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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.939360093645937819377993568936750.11
214.979447294449944600.02
单位质量响应值RSD%判断
6274.286309.950.41数据可信
供试品溶液-24090901批-氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min162881-6288164.78463.844.0564.7863.844.05
261388-6138863.24663.25
363590-6359065.51565.51
457243-5724358.97658.98
562473-6247364.36464.36
664219-6421966.16366.16
10min179147-7914781.54381.262.0381.6581.372.03
279270-7927081.66981.77
381542-8154284.01084.12
477271-7727179.61079.71
577187-7718779.52379.63
678826-7882681.21281.32
15min185803-8580388.40088.521.0788.6488.761.07
286101-8610188.70788.95
387567-8756790.21790.47
485708-8570888.30288.53
584809-8480987.37687.62
685529-8552988.11888.36
20min187796-8779690.45391.270.9990.8491.660.99
288613-8861391.29591.68
390073-9007392.79993.20
488328-8832891.00191.38
587718-8771890.37390.76
688982-8898291.67592.07
30min190073-9007392.79992.662.1493.3493.202.14
291501-9150194.27194.81
390893-9089393.64494.20
486211-8621188.82089.35
589921-8992192.64393.18
691043-9104393.79994.34
45min191154-9115493.91394.480.6794.6195.170.67
292542-9254295.34396.04
391873-9187394.65495.36
491308-9130894.07294.75
591075-9107593.83294.52
692248-9224895.04095.74
极限192001-9200194.78694.830.4695.6495.680.47
292542-9254295.34396.20
391918-9191894.70095.57
491422-9142294.18995.02
591877-9187794.65895.50
692494-9249495.29496.15
氨氯地平阿托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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.623667783665873665093660073659643663690.10
211.683706163708293707220.05
单位质量响应值RSD%判断
31529.1731739.900.48数据可信
供试品溶液-24090901批-阿托伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min167305-6730517.57415.697.7917.5715.697.80
261368-6136816.02416.02
360626-6062615.83015.83
453061-5306113.85513.85
560625-6062515.83015.83
657653-5765315.05415.05
10min1106129-10612927.71126.244.2927.7426.274.29
2100826-10082626.32726.35
3104999-10499927.41627.44
496154-9615425.10725.13
598656-9865625.76025.79
696231-9623125.12725.15
15min1132937-13293734.71133.364.0434.7933.434.04
2123321-12332132.20032.27
3135466-13546635.37235.44
4125438-12543832.75332.82
5125816-12581632.85232.92
6123554-12355432.26132.33
20min1151410-15141039.53538.383.5639.6738.503.56
2139978-13997836.55036.67
3154299-15429940.28940.42
4147532-14753238.52238.64
5144691-14469137.78037.90
6144046-14404637.61237.73
30min1172809-17280945.12244.263.8645.3244.453.86
2159657-15965741.68841.87
3177826-17782646.43246.63
4173753-17375345.36945.55
5165969-16596943.33643.52
6167095-16709543.63043.81
45min1190972-19097249.86549.293.6950.1449.553.68
2177949-17794946.46446.72
3195930-19593051.15951.43
4195629-19562951.08151.34
5184127-18412748.07748.34
6188036-18803649.09849.35
极限1201883-20188352.71452.973.4953.0753.323.49
2191527-19152750.01050.34
3211177-21117755.14055.50
4209684-20968454.75155.10
5202375-20237552.84253.18
6200577-20057752.37352.71
氨氯地平阿托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100374-202106 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.939331193489934339341893347934000.08
214.979391793929939230.01
单位质量响应值RSD%判断
6255.866274.080.21数据可信
供试品溶液-24090902批-氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min158847-5884760.89066.976.1560.8966.976.16
260832-6083262.94462.94
365580-6558067.85767.86
466482-6648268.79168.79
568613-6861370.99671.00
667973-6797370.33370.33
10min178707-7870781.44086.474.0281.5486.584.02
282200-8220085.05485.16
382087-8208784.93885.05
486408-8640889.40989.52
588075-8807591.13391.25
683944-8394486.85986.98
15min184582-8458287.51992.433.8687.7692.683.86
288050-8805091.10891.35
387337-8733790.37090.62
492949-9294996.17796.44
593575-9357596.82497.09
689463-8946392.57092.83
20min187022-8702290.04494.333.8590.4394.743.85
289659-8965992.77293.17
388653-8865391.73292.14
494833-9483398.12698.55
595871-9587199.20099.63
690951-9095194.10994.53
30min188538-8853891.61395.623.6492.1596.183.64
290856-9085694.01194.56
389806-8980692.92593.48
495722-9572299.04699.63
597013-97013100.382100.98
692519-9251995.73296.30
45min188810-8881091.89495.783.4992.5896.503.49
290844-9084493.99994.71
390103-9010393.23293.94
495763-9576399.08899.84
596860-96860100.224100.99
693001-9300196.23096.96
极限189024-8902492.11595.943.5892.9596.823.58
291099-9109994.26295.13
390134-9013493.26494.13
495406-9540698.71999.64
597685-97685101.077102.01
692970-9297096.19897.09
氨氯地平阿托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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.621812931813431811231809891806731810840.15
211.681817931819531818730.07
单位质量响应值RSD%判断
15583.8215571.320.06数据可信
供试品溶液-24090902批-阿托伐他汀钙-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min124007-2400712.73012.675.3512.7312.675.34
221868-2186811.59611.60
325364-2536413.44913.45
423217-2321712.31112.31
525077-2507713.29713.30
623792-2379212.61612.62
10min143143-4314322.87722.874.9122.9022.894.92
244575-4457523.63623.66
344391-4439123.53823.56
442387-4238722.47622.50
544974-4497423.84723.87
639288-3928820.83220.85
15min157502-5750230.49030.825.7830.5530.885.78
260823-6082332.25132.31
359861-5986131.74131.80
457524-5752430.50230.56
560980-6098032.33532.40
652029-5202927.58827.64
20min168991-6899136.58236.695.9536.6936.805.95
271472-7147237.89838.01
370067-7006737.15337.27
469442-6944236.82236.93
573684-7368439.07139.19
661544-6154432.63432.74
30min183770-8377044.41944.345.5444.5944.515.53
285787-8578745.48945.66
384227-8422744.66144.84
484422-8442244.76544.93
588589-8858946.97447.16
674875-7487539.70239.86
45min198310-9831052.12951.825.1552.3752.065.14
2100148-10014853.10353.35
396463-9646351.14951.40
4100103-10010353.08053.32
5102892-10289254.55854.82
688441-8844146.89647.12
极限1106258-10625856.34356.515.0056.6856.855.00
2108554-10855457.56157.90
3104788-10478855.56455.90
4109823-10982358.23458.57
5112743-11274359.78260.13
697320-9732051.60451.90
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