奥美沙坦酯氨氯地平片项目信息
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070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107527375426753587528875297753280.09
2 16.057619475995760940.19
单位质量响应值RSD%判断
4678.764741.060.94数据可信
供试品溶液-24122502批-氨氯地平-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%
5min154996-5499675.62275.552.4875.6275.552.48
252573-5257372.29072.29
355360-5536076.12276.12
455931-5593176.90776.91
556413-5641377.57077.57
654389-5438974.78774.79
10min165878-6587890.58590.820.8190.7190.950.81
266691-6669191.70391.82
365710-6571090.35490.48
465475-6547590.03190.16
566743-6674391.77491.90
665814-6581490.49790.62
15min168406-6840694.06193.210.9594.3493.490.95
267283-6728392.51792.79
368057-6805793.58193.86
466848-6684891.91992.20
568462-6846294.13894.42
667674-6767493.05493.33
20min168900-6890094.74094.220.6595.1794.650.65
267800-6780093.22893.66
368904-6890494.74695.18
468389-6838994.03894.47
568831-6883194.64595.08
668286-6828693.89694.33
30min169198-6919895.15095.361.0395.7495.941.03
268064-6806493.59194.17
369656-6965695.78096.37
469629-6962995.74396.33
570171-7017196.48897.08
669375-6937595.39395.98
45min169780-6978095.95095.310.8196.7096.060.81
268665-6866594.41795.16
369601-6960195.70496.46
468746-6874694.52895.28
570009-7000996.26597.02
669091-6909195.00395.75
60min169658-6965895.78295.201.0696.6996.111.06
268261-6826193.86294.76
369299-6929995.28996.20
468635-6863594.37695.28
570316-7031696.68797.61
669242-6924295.21096.11
极限170314-7031496.68495.551.3097.7596.611.28
269351-6935195.36096.41
370288-7028896.64997.72
469961-6996196.19997.26
569012-6901294.89495.97
667993-6799393.49394.56
奥美沙坦酯氨氯地平片项目信息
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070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107585676063757697563175660757960.23
2 16.057656076398764790.15
单位质量响应值RSD%判断
4707.834765.050.86数据可信
供试品溶液-24122701批-氨氯地平-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%
5min153541-5354173.20872.062.4473.2172.062.44
251565-5156570.50670.51
354582-5458274.63174.63
452946-5294672.39572.39
551087-5108769.85369.85
652480-5248071.75771.76
10min164358-6435887.99889.141.5188.1289.261.51
265829-6582990.01090.13
366755-6675591.27691.40
464095-6409587.63987.76
565220-6522089.17789.29
664914-6491488.75988.88
15min166111-6611190.39591.921.5890.6692.181.57
267029-6702991.65191.92
366150-6615090.44990.73
467288-6728892.00592.27
568883-6888394.18694.45
667882-6788292.81793.08
20min166794-6679491.32993.031.0091.7593.451.00
267999-6799992.97793.40
368817-6881794.09594.52
467987-6798792.96093.38
568258-6825893.33193.75
668363-6836393.47593.90
30min168144-6814493.17594.311.1693.7594.891.16
268529-6852993.70294.28
370357-7035796.20196.79
469445-6944594.95495.53
568654-6865493.87294.45
668720-6872093.96394.54
45min168521-6852193.69194.330.4494.4295.060.44
268845-6884594.13494.87
369284-6928494.73495.48
469126-6912694.51895.25
568846-6884694.13594.87
669292-6929294.74595.48
60min168273-6827393.35294.301.0194.2395.191.01
267939-6793992.89593.78
369576-6957695.13396.04
469524-6952495.06295.95
569370-6937094.85195.74
669122-6912294.51295.40
极限168527-6852793.69995.411.2594.7496.461.24
268881-6888194.18395.23
370531-7053196.43997.50
470112-7011295.86696.92
570578-7057896.50397.55
670034-7003495.75996.81
奥美沙坦酯氨氯地平片项目信息
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070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107582375811755187557375723756900.19
2 16.057519275308752500.11
单位质量响应值RSD%判断
4701.244688.470.20数据可信
供试品溶液-1批-氨氯地平-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%
5min157769-5776979.68677.983.4179.6977.983.41
255148-5514876.07176.07
357814-5781479.74879.75
454388-5438875.02275.02
559072-5907281.48381.48
654996-5499675.86175.86
10min166417-6641791.61590.441.6891.7590.571.68
263885-6388588.12288.25
366224-6622491.34991.48
464713-6471389.26489.39
566702-6670292.00892.14
665445-6544590.27490.40
15min168666-6866694.71793.971.5395.0094.251.53
267320-6732092.86093.13
367847-6784793.58793.87
467433-6743393.01693.29
569996-6999696.55296.84
667494-6749493.10093.38
20min169287-6928795.57495.031.3896.0295.471.38
268251-6825194.14594.57
368221-6822194.10394.54
467743-6774393.44493.87
569935-6993596.46896.92
669931-6993196.46296.89
30min170583-7058397.36195.991.5197.9696.581.51
268277-6827794.18194.77
369806-6980696.29096.89
468471-6847194.44895.03
570801-7080197.66298.27
669576-6957695.97296.57
45min170682-7068297.49896.220.9498.2696.970.95
268993-6899395.16895.91
369827-6982796.31997.08
469002-6900295.18195.92
570066-7006696.64897.42
669945-6994596.48197.23
60min170410-7041097.12396.461.4998.0597.381.48
268483-6848394.46595.37
369808-6980896.29297.21
469063-6906395.26596.17
571330-7133098.39299.33
670486-7048697.22898.14
极限171614-7161498.78497.611.1899.8798.681.18
269661-6966196.09097.15
370251-7025196.90397.98
470443-7044397.16898.23
571846-7184699.104100.20
670748-7074897.58998.66
奥美沙坦酯氨氯地平片项目信息
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070220417对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.107666676420764977634476309764470.19
2 16.057720677140771730.07
单位质量响应值RSD%判断
4748.264808.290.89数据可信
供试品溶液-2批-氨氯地平-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%
5min154620-5462074.03077.723.4974.0377.723.49
258329-5832979.05779.06
355461-5546175.17075.17
458158-5815878.82578.82
560057-6005781.39981.40
657422-5742277.82777.83
10min163722-6372286.36689.292.0486.4989.422.04
266399-6639989.99490.13
364890-6489087.94988.07
466008-6600889.46589.60
567059-6705990.88991.02
667178-6717891.05091.18
15min167234-6723491.12691.631.0591.3991.911.05
267416-6741691.37391.65
367463-6746391.43791.71
467316-6731691.23791.52
569030-6903093.56093.85
667191-6719191.06891.35
20min169122-6912293.68593.030.9694.1093.460.96
268141-6814192.35692.79
368389-6838992.69293.12
467807-6780791.90392.34
569586-6958694.31494.76
668802-6880293.25193.68
30min169555-6955594.27293.841.3494.8594.431.34
269062-6906293.60494.19
368870-6887093.34493.92
467701-6770191.75992.34
570325-7032595.31695.92
669911-6991194.75595.34
45min169574-6957494.29893.260.9295.0394.000.92
268574-6857492.94293.69
368858-6885893.32794.06
468361-6836192.65493.39
569490-6949094.18494.94
667979-6797992.13692.88
60min168788-6878893.23293.491.7694.1294.391.75
268605-6860592.98493.88
369449-6944994.12895.02
467009-6700990.82191.71
569322-6932293.95694.87
670696-7069695.81896.72
极限170513-7051395.57094.300.9796.6295.350.96
269708-6970894.47995.53
369334-6933493.97295.02
468866-6886693.33894.38
568881-6888193.35994.43
670153-7015395.08396.14
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