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%
115.399446993881944289453994341943320.28
215.459429894187942420.09
单位质量响应值RSD%判断
6129.436099.810.35数据可信
供试品溶液-GF9440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%
5min177212-7721281.85880.872.4381.8680.882.43
277177-7717781.82181.82
374531-7453179.01679.02
479032-7903283.78883.79
574211-7421178.67678.68
675538-7553880.08380.08
10min188128-8812893.43193.631.5893.5793.771.58
288375-8837593.69393.83
388039-8803993.33693.47
490440-9044095.88296.02
586123-8612391.30591.44
688800-8880094.14394.28
15min191526-9152697.03397.561.3597.3397.851.36
291364-9136496.86297.15
391827-9182797.35297.64
493895-9389599.54599.84
590467-9046795.91196.19
693056-9305698.65598.95
20min191899-9189997.42998.191.2997.8898.641.29
292330-9233097.88698.34
392285-9228597.83898.29
494417-94417100.098100.56
591150-9115096.63597.08
693623-9362399.25699.71
30min192051-9205197.59098.181.2598.2198.801.25
291955-9195597.48898.11
392372-9237297.93098.54
494416-94416100.097100.73
591296-9129696.78997.39
693562-9356299.19299.81
45min191676-9167697.19297.871.2697.9798.651.26
291968-9196897.50298.28
391907-9190797.43798.21
494032-9403299.690100.49
590913-9091396.38397.15
693374-9337498.99299.78
极限191233-9123396.72397.461.1797.6698.401.18
291570-9157097.08098.02
391639-9163997.15398.09
493504-9350499.130100.10
590689-9068996.14697.07
692944-9294498.53799.49
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%
111.331754561764271755071753391752511755960.28
211.301757761754561756160.13
单位质量响应值RSD%判断
15498.3215541.240.20数据可信
供试品溶液-GF9440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%
5min125449-2544913.54513.254.5813.5413.244.59
224333-2433312.95112.95
323063-2306312.27512.27
426224-2622413.95713.96
525684-2568413.67013.67
624563-2456313.07313.07
10min157001-5700130.33729.492.4330.3629.512.43
254938-5493829.23929.26
354953-5495329.24729.27
456944-5694430.30730.33
555094-5509429.32229.35
653506-5350628.47728.50
15min178112-7811241.57340.302.5741.6540.372.57
273443-7344339.08839.16
375256-7525640.05340.12
477987-7798741.50741.58
574137-7413739.45839.53
675407-7540740.13340.20
20min191236-9123648.55847.382.5048.7047.522.50
286282-8628245.92146.06
387520-8752046.58046.72
492095-9209549.01549.16
588289-8828946.99047.13
688694-8869447.20547.34
30min1106892-10689256.89155.712.5957.1155.932.60
2101466-10146654.00354.21
3102241-10224154.41554.63
4108602-10860257.80158.03
5104249-10424955.48455.70
6104646-10464655.69555.91
45min1119593-11959363.65062.032.2263.9762.342.22
2112966-11296660.12360.43
3113934-11393460.63960.94
4118458-11845863.04663.37
5116866-11686662.19962.51
6117434-11743462.50162.81
极限1126240-12624067.18866.841.7667.6167.251.76
2122515-12251565.20665.61
3123455-12345565.70666.11
4128340-12834068.30668.73
5125881-12588166.99767.41
6127092-12709267.64268.05
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%
115.399376193730937159370293548936910.09
215.459452194378944500.11
单位质量响应值RSD%判断
6087.786113.270.30数据可信
供试品溶液-LC1771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%
5min173939-7393978.56976.991.2378.5776.991.23
271463-7146375.93875.94
371894-7189476.39676.40
472026-7202676.53676.54
572969-7296977.53877.54
672404-7240476.93876.94
10min188171-8817193.69294.251.4593.8294.371.45
287890-8789093.39493.52
388866-8886694.43194.56
491060-9106096.76296.89
587399-8739992.87293.00
688764-8876494.32294.45
15min191526-9152697.25798.921.7397.5499.201.73
292217-9221797.99298.27
394090-9409099.982100.27
495791-95791101.789102.08
591910-9191097.66597.95
692992-9299298.81599.10
20min192409-9240998.19699.571.6498.64100.021.64
293138-9313898.97099.42
394340-94340100.248100.70
496410-96410102.447102.91
592295-9229598.07498.52
693611-9361199.47399.92
30min192334-9233498.11699.471.7498.73100.091.74
292488-9248898.28098.89
394525-94525100.444101.06
496448-96448102.488103.12
592408-9240898.19598.80
693471-9347199.32499.94
45min192369-9236998.15399.421.6398.93100.201.63
293044-9304498.87099.64
394327-94327100.234101.02
496241-96241102.268103.07
592161-9216197.93298.71
693234-9323499.07299.85
极限191477-9147797.20599.031.8298.1599.981.81
292359-9235998.14299.08
393908-9390899.788100.74
495949-95949101.957102.93
591724-9172497.46898.40
693769-9376999.641100.59
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%
111.331748161746551749211748481747661748010.06
211.301767771765491766630.10
单位质量响应值RSD%判断
15428.1615633.890.94数据可信
供试品溶液-LC1771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%
5min128738-2873815.28513.737.1815.2813.727.17
224428-2442812.99212.99
323806-2380612.66212.66
424660-2466013.11613.12
526409-2640914.04614.05
626793-2679314.25014.25
10min150446-5044626.83026.633.5026.8626.663.50
248018-4801825.53925.56
349130-4913026.13026.15
452001-5200127.65727.68
548698-4869825.90125.92
652178-5217827.75227.78
15min170012-7001237.23738.042.6337.3138.102.62
270244-7024437.36037.42
372667-7266738.64938.71
472651-7265138.64038.71
569427-6942736.92636.99
674105-7410539.41439.48
20min184578-8457844.98446.423.7045.1246.563.69
284597-8459744.99445.12
387572-8757246.57646.71
491481-9148148.65548.79
584626-8462645.00945.14
690836-9083648.31248.45
30min1101109-10110953.77656.173.0953.9856.383.09
2105642-10564256.18756.39
3105176-10517655.93956.15
4108549-10854957.73357.95
5103251-10325154.91555.12
6109922-10992258.46358.68
45min1113134-11313460.17262.722.6960.4763.022.69
2115571-11557161.46861.76
3117994-11799462.75763.06
4121366-12136664.55064.86
5118449-11844962.99963.29
6121000-12100064.35564.67
极限1119445-11944563.52866.362.9863.9366.762.97
2122654-12265465.23565.63
3125894-12589466.95867.36
4130335-13033569.32069.74
5123818-12381865.85466.25
6126424-12642467.24067.66
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