比索洛尔左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
114.711088421090881084711086861088861087950.22
214.691082861082501082680.03
单位质量响应值RSD%判断
7395.997370.180.25数据可信
加速3月-供试品溶液-8145795批-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%
5min189548-8954876.57975.663.1376.5875.663.13
289294-8929476.36276.36
390018-9001876.98176.98
483155-8315571.11271.11
590841-9084177.68577.68
687997-8799775.25375.25
10min199035-9903584.69285.882.1784.8286.012.17
297372-9737283.27083.40
3102514-10251487.66787.80
499203-9920384.83684.95
5102072-10207287.28987.42
6102367-10236787.54187.67
15min1104878-10487889.68990.221.2889.9690.491.28
2104942-10494289.74490.01
3107038-10703891.53691.81
4103447-10344788.46588.72
5106717-10671791.26191.54
6105970-10597090.62390.89
20min1107969-10796992.33292.031.4192.7592.451.41
2107188-10718891.66492.08
3109532-10953293.66994.10
4105189-10518989.95590.36
5108729-10872992.98293.41
6107059-10705991.55491.98
30min1108599-10859992.87193.421.2393.4493.991.23
2108651-10865192.91593.48
3111195-11119595.09195.67
4107324-10732491.78192.34
5109881-10988193.96794.55
6109762-10976293.86694.44
45min1110498-11049894.49594.951.4395.2295.681.43
2109790-10979093.88994.61
3112284-11228496.02296.76
4108855-10885593.09093.80
5111732-11173295.55096.29
6112999-11299996.63497.37
极限1109506-10950693.64794.791.0294.5395.681.02
2109710-10971093.82194.70
3112194-11219495.94596.85
4110419-11041994.42795.29
5111412-11141295.27796.17
6111822-11182295.62796.52
比索洛尔左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
114.711081501076881074631076901081101078200.28
214.691079551075641077600.26
单位质量响应值RSD%判断
7329.717335.600.06数据可信
长期3月-供试品溶液-8145795批-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%
5min191733-9173378.98779.143.0278.9979.143.02
289539-8953977.09877.10
388635-8863576.31976.32
496514-9651483.10483.10
592607-9260779.73979.74
692463-9246379.61579.62
10min1105857-10585791.14889.732.2291.2889.862.22
2102505-10250588.26288.39
3101055-10105587.01487.14
4107235-10723592.33592.47
5103342-10334288.98389.12
6105240-10524090.61790.75
15min1108568-10856893.48393.022.0693.7793.302.06
2107155-10715592.26692.54
3105295-10529590.66490.94
4111817-11181796.28096.57
5106815-10681591.97392.25
6108526-10852693.44793.73
20min1109658-10965894.42194.161.5194.8694.601.51
2108701-10870193.59794.03
3106643-10664391.82592.25
4111665-11166596.14996.60
5109605-10960594.37694.81
6109862-10986294.59795.04
30min1111645-11164596.13295.961.7396.7396.561.73
2111912-11191296.36296.95
3108722-10872293.61594.19
4114263-11426398.38699.00
5109932-10993294.65795.25
6112226-11222696.63297.23
45min1112774-11277497.10496.982.2297.8697.732.22
2113864-11386498.04398.79
3108834-10883493.71294.44
4116148-116148100.009100.79
5111049-11104995.61996.37
6113080-11308097.36898.13
极限1112697-11269797.03896.741.9897.9697.651.98
2113329-11332997.58298.49
3109569-10956994.34595.23
4115602-11560299.539100.48
5110093-11009394.79695.70
6112782-11278297.11198.03
比索洛尔左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
114.711077461072361084111085031080321079860.48
214.691084261084931084600.05
单位质量响应值RSD%判断
7340.997383.250.41数据可信
中间条件3月-供试品溶液-8145795批-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%
5min186927-8692774.55077.374.3974.5577.374.39
285471-8547173.30173.30
394669-9466981.18981.19
488715-8871576.08376.08
594983-9498381.45981.46
690524-9052477.63577.63
10min1100884-10088486.51989.362.7786.6489.492.77
2101110-10111086.71386.84
3107066-10706691.82191.96
4105448-10544890.43490.56
5107412-10741292.11892.25
6103281-10328188.57588.70
15min1104245-10424589.40292.823.0489.6793.103.05
2105554-10555490.52490.79
3111951-11195196.01196.30
4108502-10850293.05393.33
5112172-11217296.20096.49
6106973-10697391.74192.02
20min1107228-10722891.96094.702.8892.3895.132.88
2107502-10750292.19592.61
3114460-11446098.16298.61
4110566-11056694.82395.26
5113975-11397597.74698.20
6108786-10878693.29693.73
30min1109511-10951193.91895.822.5594.4996.412.55
2108767-10876793.28093.85
3115705-11570599.23099.84
4111013-11101395.20695.80
5114756-11475698.41699.03
6110643-11064394.88995.47
45min1110872-11087295.08595.652.7095.8196.402.69
2110505-11050594.77095.50
3115138-11513898.74499.52
4112567-11256796.53997.29
5113607-11360797.43198.21
6106518-10651891.35192.09
极限1110732-11073294.96596.952.8795.8597.862.87
2109744-10974494.11895.00
3117957-117957101.161102.10
4112697-11269796.65097.56
5115963-11596399.451100.39
6111220-11122095.38496.28
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