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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.058587385720858548557985657857370.15
210.038555085505855280.04
单位质量响应值RSD%判断
8531.048527.220.04数据可信
长期12月-供试品溶液-2024110221批-比索洛尔-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%
5min195400-95400100.46598.811.51100.4798.811.51
294830-9483099.86599.87
393429-9342998.39098.39
494014-9401499.00699.01
593944-9394498.93298.93
691331-9133196.18096.18
10min196076-96076101.17799.651.35101.3499.821.35
295375-95375100.439100.61
394223-9422399.22699.39
494840-9484099.876100.04
594893-9489399.932100.10
692349-9234997.25297.41
15min196166-96166101.27299.551.36101.6199.881.36
295176-95176100.230100.56
393865-9386598.84999.18
494508-9450899.52699.86
595054-95054100.101100.43
692434-9243497.34297.66
20min195844-95844100.93399.161.40101.4499.661.40
294847-9484799.883100.38
393806-9380698.78799.28
494371-9437199.38299.88
594205-9420599.20799.71
691888-9188896.76797.25
30min195388-95388100.45399.071.05101.1399.741.05
294576-9457699.598100.27
393685-9368598.65999.32
494050-9405099.04499.71
594312-9431299.32099.98
692459-9245997.36898.01
45min195625-95625100.70298.761.40101.5499.581.40
294254-9425499.259100.09
393162-9316298.10998.93
493924-9392498.91199.74
594036-9403699.02999.86
691670-9167096.53797.35
极限195596-95596100.67298.571.55101.6899.561.55
294047-9404799.041100.04
392858-9285897.78898.78
493969-9396998.95899.95
593867-9386798.85199.85
691243-9124396.08897.06
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.764817548287477404795548149480610.45
213.724796347935479490.05
单位质量响应值RSD%判断
3492.813494.830.05数据可信
长期12月-供试品溶液-2024110221批-左氨氯地平-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%
5min144848-4484880.38074.907.7180.3874.907.70
245003-4500380.65880.66
339506-3950670.80670.81
436707-3670765.78965.79
541854-4185475.01475.01
642811-4281176.72976.73
10min156132-56132100.604103.522.33100.74103.652.32
258420-58420104.705104.84
359575-59575106.775106.89
458631-58631105.083105.19
556455-56455101.183101.31
657356-57356102.798102.93
15min156549-56549101.351101.921.96101.65102.211.96
257643-57643103.312103.62
358601-58601105.029105.33
456207-56207100.739101.02
555438-5543899.36099.65
656748-56748101.708102.01
20min155582-5558299.618100.551.65100.09101.021.65
257227-57227102.567103.05
357286-57286102.672103.14
455769-5576999.954100.41
555110-5511098.77299.23
655643-5564399.728100.20
30min155337-5533799.17997.662.2899.8298.302.26
255410-5541099.31099.96
352264-5226493.67294.31
455282-5528299.08199.70
554812-5481298.23898.86
653834-5383496.48597.12
45min155276-5527699.07099.191.1599.8799.991.15
255986-55986100.342101.16
355962-55962100.299101.10
455190-5519098.91699.70
554251-5425197.23398.02
655394-5539499.281100.08
极限151698-5169892.65796.484.7293.6297.444.68
256215-56215100.753101.74
355949-55949100.276101.24
449875-4987589.39090.34
554071-5407196.91097.86
655172-5517298.88499.84
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.058593086125860018619486009860520.13
210.038608586111860980.03
单位质量响应值RSD%判断
8562.398584.050.18数据可信
长期12月-供试品溶液-2024110321批-比索洛尔-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%
5min194543-9454399.05198.542.4199.0598.542.41
291067-9106795.40995.41
393232-9323297.67897.68
496464-96464101.064101.06
592312-9231296.71496.71
696695-96695101.306101.31
10min195388-9538899.93699.892.51100.10100.062.51
291219-9121995.56995.73
394230-9423098.72398.89
497687-97687102.345102.51
596186-96186100.772100.93
697367-97367102.010102.18
15min195204-9520499.74499.191.18100.0899.521.18
293979-9397998.46098.78
394060-9406098.54598.87
495161-9516199.699100.04
593281-9328197.72998.06
696356-96356100.951101.29
20min194465-9446598.96998.351.8699.4798.851.85
291745-9174596.12096.60
393791-9379198.26398.75
493424-9342497.87998.38
592945-9294597.37797.87
696896-96896101.516102.02
30min194224-9422498.71798.642.4099.3899.302.40
291796-9179696.17396.82
392991-9299197.42598.08
496900-96900101.520102.19
592166-9216696.56197.22
696812-96812101.428102.10
45min193788-9378898.26098.592.3899.0999.422.37
291867-9186796.24797.05
393627-9362798.09198.91
496026-96026100.605101.44
591900-9190096.28297.10
697422-97422102.067102.91
极限194757-9475799.27598.462.69100.2799.452.68
291412-9141295.77196.73
393167-9316797.60998.59
496562-96562101.166102.17
591057-9105795.39996.37
696937-96937101.559102.57
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.764862048595484774850048572485530.13
213.724844748310483780.21
单位质量响应值RSD%判断
3528.563526.090.05数据可信
长期12月-供试品溶液-2024110321批-左氨氯地平-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%
5min144277-4427778.60377.105.5478.6077.105.54
243980-4398078.07578.08
346559-4655982.65482.65
439331-3933169.82269.82
543980-4398078.07578.08
642457-4245775.37275.37
10min156631-56631100.53492.6911.39100.6792.8211.37
255434-5543498.40998.54
348584-4858486.24986.39
455545-5554598.60698.72
541637-4163773.91674.05
655458-5545898.45298.58
15min155897-5589799.23198.692.4599.5398.972.44
257157-57157101.468101.76
353240-5324094.51494.80
456602-56602100.483100.76
555313-5531398.19498.45
655343-5534398.24898.54
20min154152-5415296.13397.752.0096.6098.201.99
254774-5477497.23897.70
356289-5628999.927100.37
456111-5611199.611100.06
555514-5551498.55198.97
653533-5353395.03495.49
30min154255-5425596.31696.481.4696.9497.091.44
254236-5423696.28296.91
355586-5558698.67999.28
453608-5360895.16895.78
554895-5489597.45298.03
653507-5350794.98895.60
45min153609-5360995.16995.631.8595.9596.401.83
253846-5384695.59096.38
355498-5549898.52399.29
452405-5240593.03293.80
554075-5407595.99796.74
653783-5378395.47896.25
极限153852-5385295.60195.391.2496.5496.321.23
253660-5366095.26096.20
354895-5489597.45298.39
452984-5298494.06094.99
553788-5378895.48796.39
653231-5323194.49895.43
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.058546085505855578545385480854910.05
210.038590985736858220.15
单位质量响应值RSD%判断
8506.578556.530.42数据可信
长期12月-供试品溶液-2024110421批-比索洛尔-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%
5min195853-95853100.915100.172.20100.91100.172.20
297907-97907103.077103.08
395424-95424100.463100.46
492145-9214597.01197.01
596267-96267101.351101.35
693299-9329998.22698.23
10min196400-96400101.491101.222.09101.66101.382.10
299016-99016104.245104.42
396119-96119101.195101.36
493672-9367298.61998.78
597479-97479102.627102.80
694152-9415299.12499.29
15min195709-95709100.763101.012.02101.10101.342.02
298744-98744103.958104.30
396308-96308101.394101.73
493646-9364698.59198.92
597224-97224102.358102.70
694029-9402998.99499.32
20min196192-96192101.272100.851.92101.78101.361.92
298452-98452103.651104.17
396106-96106101.181101.69
493470-9347098.40698.90
596597-96597101.698102.21
693944-9394498.90599.40
30min195751-95751100.807100.501.97101.48101.171.98
298274-98274103.464104.16
395483-95483100.525101.20
492971-9297197.88198.53
596420-96420101.512102.19
693863-9386398.82099.48
45min195703-95703100.757100.211.88101.60101.051.88
297690-97690102.849103.71
395374-95374100.410101.25
492970-9297097.87998.70
596079-96079101.153102.00
693285-9328598.21199.03
极限194885-9488599.89699.681.70100.91100.681.70
296915-96915102.033103.07
394612-9461299.608100.62
492827-9282797.72998.71
595853-95853100.915101.93
692963-9296397.87298.86
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.764797248178478024811647863479860.34
213.724799047931479600.09
单位质量响应值RSD%判断
3487.353495.630.17数据可信
长期12月-供试品溶液-2024110421批-左氨氯地平-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%
5min154366-5436697.50498.241.3297.5098.241.32
255871-55871100.203100.20
354438-5443897.63397.63
453903-5390396.67496.67
554722-5472298.14298.14
655371-5537199.30699.31
10min154413-5441397.58899.241.4597.7599.411.45
256582-56582101.478101.65
355203-5520399.00599.17
454728-5472898.15398.31
555154-5515498.91799.08
655939-55939100.325100.49
15min154918-5491898.49498.951.7198.8299.281.71
256516-56516101.360101.70
354697-5469798.09898.43
454280-5428097.35097.67
554456-5445697.66597.99
656173-56173100.745101.08
20min154509-5450997.76098.651.3498.2599.141.33
255845-55845100.156100.66
354942-5494298.53799.03
454180-5418097.17097.66
554601-5460197.92598.42
655942-55942100.330100.83
30min154611-5461197.94398.481.7698.6099.141.75
256115-56115100.641101.31
354482-5448297.71298.37
453516-5351695.97996.63
554864-5486498.39799.05
655884-55884100.226100.89
45min154763-5476398.21697.961.0899.0398.781.08
254801-5480198.28499.12
354316-5431697.41498.23
453922-5392296.70897.52
554307-5430797.39898.22
655616-5561699.746100.58
极限153885-5388596.64197.691.1397.6298.671.13
255198-5519898.996100.00
353953-5395396.76397.74
454028-5402896.89897.87
554554-5455497.84198.82
655195-5519598.99199.99
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