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%
1 15.069677096805966649630996378965850.24
2 15.019675997111969350.26
单位质量响应值RSD%判断
6413.356458.030.50数据可信
加速6月-供试品溶液-2025021321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%
5min155040-5504055.44148.1711.2655.4448.1611.26
249344-4934449.70449.70
345910-4591046.24546.24
440380-4038040.67440.67
552061-5206152.44052.44
644171-4417144.49344.49
10min184759-8475985.37780.185.0285.4780.265.02
282838-8283883.44283.52
376731-7673177.29077.37
473826-7382674.36474.43
580409-8040980.99581.08
679011-7901179.58779.66
15min193752-9375294.43589.484.2894.6789.694.28
293022-9302293.70093.92
384386-8438685.00185.21
487889-8788988.53088.72
585819-8581986.44486.67
688106-8810688.74888.95
20min196585-9658597.28993.963.9497.6894.333.93
298084-9808498.79999.18
388205-8820588.84889.20
493458-9345894.13994.48
590590-9059091.25091.62
692779-9277993.45593.81
30min199383-99383100.10797.152.79100.6697.672.80
299539-99539100.264100.81
393239-9323993.91994.41
496395-9639597.09897.59
593688-9368894.37194.89
696431-9643197.13497.64
45min199217-9921799.94097.861.84100.6698.541.85
298853-9885399.573100.28
395347-9534796.04296.69
497306-9730698.01598.67
594813-9481395.50496.18
697396-9739698.10698.78
极限198944-9894499.66597.972.16100.5598.822.16
299508-99508100.233101.11
394286-9428694.97395.79
497381-9738198.09198.91
595203-9520395.89796.73
698257-9825798.97399.81
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
1 11.641824041812011823161824901823651821550.30
2 11.571825911823861824880.08
单位质量响应值RSD%判断
15649.0515772.520.56数据可信
加速6月-供试品溶液-2025021321批-阿托伐他汀钙-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%
5min1114960-11496060.56954.388.4460.5754.388.44
2106777-10677756.25856.26
398002-9800251.63451.63
494639-9463949.86249.86
5110428-11042858.18158.18
694517-9451749.79849.80
10min1157745-15774583.11177.386.1583.2177.476.15
2155040-15504081.68681.78
3134491-13449170.85970.95
4141359-14135974.47874.56
5150676-15067679.38779.48
6141927-14192774.77774.86
15min1174903-17490392.15187.535.0392.3987.755.04
2174946-17494692.17492.40
3152766-15276680.48880.69
4165090-16509086.98187.19
5166778-16677887.87088.10
6162357-16235785.54185.75
20min1182378-18237896.08992.344.7096.4892.714.70
2184612-18461297.26697.65
3161390-16139085.03285.37
4176295-17629592.88493.24
5174115-17411591.73692.11
6172808-17280891.04791.40
30min1187549-18754998.81495.413.9099.3795.933.90
2188248-18824899.18299.73
3168952-16895289.01689.50
4182689-18268996.25396.76
5179007-17900794.31394.84
6180075-18007594.87695.38
45min1188211-18821199.16396.523.2799.8897.203.28
2189336-18933699.755100.47
3172859-17285991.07491.70
4184763-18476397.34698.01
5180683-18068395.19695.88
6183318-18331896.58597.24
极限1188363-18836399.24396.802.83100.1397.642.84
2189276-18927699.724100.60
3174837-17483792.11692.90
4184468-18446897.19198.02
5182087-18208795.93696.78
6183279-18327996.56497.39
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%
1 15.069622096324962239623796507963020.13
2 15.019625295890960710.27
单位质量响应值RSD%判断
6394.566400.470.07数据可信
加速6月-供试品溶液-2025021421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%
5min150225-5022550.89256.086.3450.8956.086.34
254800-5480055.52855.53
360122-6012260.92160.92
456779-5677957.53357.53
552852-5285253.55453.55
657285-5728558.04658.05
10min168066-6806668.97076.817.4869.0676.907.48
274628-7462875.62075.71
384282-8428285.40285.50
474883-7488375.87875.97
572897-7289773.86673.95
680076-8007681.14081.24
15min175786-7578676.79384.737.1076.9984.957.09
279660-7966080.71880.94
393112-9311294.34994.59
483069-8306984.17384.40
583585-8358584.69684.91
686508-8650887.65787.89
20min179744-7974480.80488.806.4681.1389.176.46
286051-8605187.19487.55
397161-9716198.45298.85
486276-8627687.42287.78
587345-8734588.50688.86
689263-8926390.44990.83
30min183206-8320684.31291.746.2984.7792.256.29
290111-9011191.30891.81
3100487-100487101.822102.39
487634-8763488.79889.31
590427-9042791.62892.13
691351-9135192.56593.09
45min185746-8574686.88593.295.6587.4993.955.65
290320-9032091.52092.17
3101535-101535102.884103.62
490577-9057791.78092.44
592171-9217193.39694.05
692032-9203293.25593.94
极限188256-8825689.42994.675.1490.1895.495.15
293730-9373094.97595.78
3102221-102221103.579104.49
490200-9020091.39892.21
593550-9355094.79395.60
692635-9263593.86694.70
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
1 11.641818991819701817131821051828281821030.24
2 11.571821061814311817680.27
单位质量响应值RSD%判断
15644.5915710.290.30数据可信
加速6月-供试品溶液-2025021421批-阿托伐他汀钙-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%
5min199015-9901552.27855.815.3852.2855.815.38
2106563-10656356.26456.26
3101146-10114653.40453.40
4106787-10678756.38256.38
5105340-10534055.61855.62
6115391-11539160.92560.92
10min1128305-12830567.74373.465.0167.8373.555.01
2137748-13774872.72972.82
3138073-13807372.90072.99
4138850-13885073.31173.40
5142003-14200374.97575.07
6149798-14979879.09179.19
15min1142422-14242275.19781.774.7275.4081.994.72
2152802-15280280.67780.89
3155560-15556082.13382.34
4154910-15491081.79082.01
5159413-15941384.16884.39
6164149-16414986.66886.90
20min1150193-15019379.30085.574.3379.6285.924.33
2160276-16027684.62384.97
3163571-16357186.36386.71
4160862-16086284.93385.29
5166853-16685388.09688.45
6170691-17069190.12290.50
30min1157064-15706482.92788.703.8283.3889.203.83
2166955-16695588.15088.64
3169715-16971589.60790.10
4165916-16591687.60188.10
5173334-17333491.51892.02
6175023-17502392.40992.94
45min1161224-16122485.12490.253.2685.7290.893.27
2170552-17055290.04990.69
3172200-17220090.91991.56
4169164-16916489.31689.96
5176027-17602792.94093.60
6176400-17640093.13693.82
极限1166481-16648187.89991.872.6788.6492.662.68
2174634-17463492.20492.99
3175495-17549592.65993.45
4170734-17073490.14590.93
5178388-17838894.18695.00
6178314-17831494.14794.98
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%
1 15.069704596916967909693297251969870.18
2 15.019566396286959740.46
单位质量响应值RSD%判断
6440.046394.000.51数据可信
加速6月-供试品溶液-2025021521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%
5min158020-5802058.61356.243.0058.6156.243.00
254967-5496755.52955.53
355979-5597956.55156.55
452979-5297953.52053.52
555665-5566556.23456.23
656397-5639756.97356.97
10min179891-7989180.70779.422.4780.8179.522.47
278629-7862979.43279.53
378867-7886779.67379.77
474920-7492075.68675.77
578956-7895679.76379.86
680430-8043081.25281.35
15min189804-8980490.72289.162.0090.9589.382.00
287038-8703887.92788.15
388619-8861989.52589.75
485292-8529286.16486.38
589700-8970090.61790.84
689072-8907289.98290.21
20min193776-9377694.73493.582.3195.1293.962.31
289677-8967790.59390.96
392353-9235393.29793.67
490630-9063091.55691.92
595012-9501295.98396.36
694357-9435795.32195.70
30min196047-9604797.02896.501.3497.5797.041.34
294796-9479695.76596.29
395629-9562996.60697.14
493733-9373394.69195.20
595416-9541696.39196.93
697549-9754998.54699.09
45min198044-9804499.04697.401.9099.7598.091.90
295665-9566596.64397.32
395350-9535096.32497.02
493605-9360594.56295.23
597884-9788498.88499.58
697922-9792298.92399.63
极限197224-9722498.21797.591.5099.0998.441.50
295800-9580096.77997.62
396830-9683097.81998.67
494826-9482695.79596.62
595938-9593896.91897.78
698996-98996100.008100.88
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
1 11.641841161840841835771839081840791839530.13
2 11.571811041820261815650.36
单位质量响应值RSD%判断
15803.5215692.740.50数据可信
加速6月-供试品溶液-2025021521批-阿托伐他汀钙-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%
5min1116862-11686261.42558.304.1161.4258.304.11
2115798-11579860.86660.87
3107481-10748156.49456.49
4105346-10534655.37255.37
5110240-11024057.94457.94
6109817-10981757.72257.72
10min1157214-15721482.63580.012.4682.7480.112.46
2155735-15573581.85781.96
3148873-14887378.25078.34
4147946-14794677.76377.86
5152874-15287480.35380.45
6150671-15067179.19579.29
15min1175719-17571992.36189.562.3192.6089.792.31
2172967-17296790.91591.15
3166387-16638787.45687.68
4165879-16587987.18987.41
5172331-17233190.58090.81
6169018-16901888.83989.07
20min1183677-18367796.54494.012.2696.9494.392.26
2181770-18177095.54295.93
3175159-17515992.06792.44
4174077-17407791.49891.87
5181780-18178095.54795.93
6176655-17665592.85393.23
30min1189927-18992799.82996.872.37100.3897.412.37
2185933-18593397.73098.28
3180133-18013394.68195.21
4179096-17909694.13694.66
5188000-18800098.81699.36
6182719-18271996.04196.57
45min1190227-19022799.98797.502.26100.7198.202.26
2186358-18635897.95398.66
3181545-18154595.42396.11
4180117-18011794.67395.35
5189867-18986799.798100.50
6184839-18483997.15597.85
极限1190397-190397100.07697.641.95100.9698.501.95
2186934-18693498.25699.13
3182052-18205295.69096.53
4181442-18144295.36996.20
5188796-18879699.235100.11
6185005-18500597.24298.10
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