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%
110.078631186343861538615186143862200.12
210.088630386281862920.02
单位质量响应值RSD%判断
8562.078560.710.02数据可信
长期3月-供试品溶液-2023101321批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192182-9218296.71198.511.5696.7198.511.56
294170-9417098.79698.80
393549-9354998.14598.14
496271-96271101.001101.00
594557-9455799.20299.20
692677-9267797.23097.23
10min193004-9300497.57399.391.5397.7399.561.53
295177-9517799.853100.02
394514-9451499.15799.32
496699-96699101.450101.62
595801-95801100.508100.67
693237-9323797.81897.98
15min193070-9307097.64299.401.5897.9799.731.58
295035-9503599.704100.04
394558-9455899.20499.53
496918-96918101.679102.02
595713-95713100.415100.75
693152-9315297.72898.05
20min192983-9298397.55199.431.7098.0499.931.70
296324-96324101.056101.55
394259-9425998.89099.38
496624-96624101.371101.88
595464-95464100.154100.65
693003-9300397.57298.06
30min192854-9285497.41698.971.5298.0699.631.52
294741-9474199.396100.06
394244-9424498.87499.53
496469-96469101.208101.88
595035-9503599.704100.37
692653-9265397.20597.86
45min192645-9264597.19798.801.5298.0199.621.51
294473-9447399.11499.95
394074-9407498.69699.52
496258-96258100.987101.83
595011-9501199.679100.51
692551-9255197.09897.91
极限192503-9250397.04898.621.5098.0299.611.50
294415-9441599.053100.05
393841-9384198.45199.44
495868-95868100.578101.59
595067-9506799.738100.74
692317-9231796.85297.83
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%
114.715385553791536395371253709537410.16
214.695382853837538320.02
单位质量响应值RSD%判断
3653.373664.530.22数据可信
长期3月-供试品溶液-2023101321批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153281-5328191.94192.561.0391.9492.561.04
254171-5417193.47693.48
352721-5272190.97490.97
454108-5410893.36893.37
553772-5377292.78892.79
653802-5380292.84092.84
10min153682-5368292.63395.001.6092.7995.161.60
256051-5605196.72196.88
355153-5515395.17195.32
455413-5541395.62095.78
555666-5566696.05696.21
654370-5437093.82093.97
15min154617-5461794.24695.421.1794.5595.731.17
256050-5605096.71997.04
355045-5504594.98595.29
455528-5552895.81896.13
555944-5594496.53696.85
654588-5458894.19694.51
20min153967-5396793.12494.911.6193.5995.381.61
256188-5618896.95797.44
353971-5397193.13193.60
455072-5507295.03195.51
555512-5551295.79096.27
655302-5530295.42895.90
30min154487-5448794.02295.171.1894.6495.801.19
255915-5591596.48697.13
354672-5467294.34194.96
455816-5581696.31596.95
555446-5544695.67796.31
654575-5457594.17494.80
45min154622-5462294.25594.700.7895.0395.490.78
255519-5551995.80396.60
354491-5449194.02994.81
454645-5464594.29495.09
555306-5530695.43596.23
654700-5470094.38995.17
极限154509-5450994.06095.231.2094.9996.181.20
256137-5613796.86997.83
354606-5460694.22795.16
455723-5572396.15597.11
555353-5535395.51696.47
654803-5480394.56795.51
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%
110.078634686341865308666486510864780.16
210.088630186293862970.01
单位质量响应值RSD%判断
8587.698561.210.22数据可信
长期3月-供试品溶液-2023101322批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194328-9432898.81297.741.9098.8197.741.91
289947-8994794.22294.22
394644-9464499.14399.14
492992-9299297.41297.41
593377-9337797.81697.82
694524-9452499.01799.02
10min194694-9469499.19598.462.0299.3698.622.02
290318-9031894.61194.77
395263-9526399.79199.96
493855-9385598.31698.48
594365-9436598.85099.01
695470-95470100.008100.17
15min194647-9464799.14698.231.9499.4898.561.94
290221-9022194.51094.82
394754-9475499.25899.59
493714-9371498.16998.49
594115-9411598.58998.92
695177-9517799.701100.03
20min194317-9431798.80098.111.8399.3098.601.83
290444-9044494.74395.22
394810-9481099.31799.81
493283-9328397.71798.21
593949-9394998.41598.91
695158-9515899.681100.18
30min193862-9386298.32497.961.9698.9898.621.96
290074-9007494.35694.99
394970-9497099.484100.15
493309-9330997.74498.40
593785-9378598.24398.90
695090-9509099.610100.27
45min194262-9426298.74397.881.9799.5798.701.97
289926-8992694.20094.99
394723-9472399.226100.05
493201-9320197.63198.45
593590-9359098.03998.86
694906-9490699.417100.25
极限193804-9380498.26397.561.9999.2598.541.99
289607-8960793.86694.81
394424-9442498.91299.91
492711-9271197.11898.10
593618-9361898.06899.05
694614-9461499.111100.11
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%
114.715392453897539025392953761538830.13
214.695381653736537760.11
单位质量响应值RSD%判断
3663.023660.720.05数据可信
长期3月-供试品溶液-2023101322批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154409-5440993.81293.231.6693.8193.231.66
254112-5411293.30093.30
355122-5512295.04195.04
452427-5242790.39590.39
554334-5433493.68393.68
654033-5403393.16493.16
10min155815-5581596.23694.361.8996.3994.521.89
254029-5402993.15793.31
355526-5552695.73895.90
453045-5304591.46091.61
554810-5481094.50394.66
655137-5513795.06795.22
15min155259-5525995.27894.771.8595.5995.091.85
254145-5414593.35793.67
356687-5668797.74098.06
453778-5377892.72493.03
554835-5483594.54794.86
655097-5509794.99895.31
20min156344-5634497.14894.712.0197.6295.182.01
254998-5499894.82895.29
355374-5537495.47695.96
452968-5296891.32791.79
554856-5485694.58395.05
655048-5504894.91495.39
30min155711-5571196.05794.881.6996.6995.511.69
253990-5399093.09093.71
355862-5586296.31796.96
453724-5372492.63193.24
555346-5534695.42896.06
655546-5554695.77296.40
45min154762-5476294.42192.951.5195.2293.731.51
253775-5377592.71993.50
354410-5441093.81494.61
452446-5244690.42791.19
553783-5378392.73393.52
654267-5426793.56794.36
极限154893-5489394.64793.442.0895.6094.382.07
254748-5474894.39795.33
354787-5478794.46495.42
451992-5199289.64590.56
554025-5402593.15094.09
654712-5471294.33495.28
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%
110.078629186233861478617786220862140.07
210.088628386291862870.01
单位质量响应值RSD%判断
8561.478560.220.02数据可信
长期3月-供试品溶液-2023101323批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194343-9434398.98496.382.1298.9896.382.12
293880-9388098.49898.50
391187-9118795.67395.67
489082-8908293.46493.46
591325-9132595.81895.82
691361-9136195.85695.86
10min194705-9470599.36497.022.1099.5397.182.10
294874-9487499.54199.71
391527-9152796.03096.19
489963-8996394.38994.54
591876-9187696.39696.56
691851-9185196.37096.53
15min194626-9462699.28196.952.0699.6197.282.06
294724-9472499.38499.71
391517-9151796.01996.34
489894-8989494.31694.63
591956-9195696.48096.80
691726-9172696.23996.56
20min194668-9466899.32596.862.1399.8297.342.13
294620-9462099.27599.77
391494-9149495.99596.47
489672-8967294.08394.55
591756-9175696.27096.75
691714-9171496.22696.71
30min194340-9434098.98196.482.1499.6497.132.14
294325-9432598.96599.63
391017-9101795.49596.13
489462-8946293.86394.49
591523-9152396.02696.67
691091-9109195.57296.21
45min194246-9424698.88296.512.2599.7197.312.24
294506-9450699.15599.98
391308-9130895.80096.60
489051-8905193.43294.22
591390-9139095.88696.69
691381-9138195.87796.68
极限193903-9390398.52396.371.7899.5197.341.78
293985-9398598.60999.60
391077-9107795.55896.52
490524-9052494.97795.92
590986-9098695.46296.42
690643-9064395.10296.06
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100546-202105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%
114.715379153827537165373853692537530.11
214.695379553836538160.06
单位质量响应值RSD%判断
3654.183663.440.18数据可信
长期3月-供试品溶液-2023101323批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155774-5577496.24694.142.2796.2594.142.27
253806-5380692.85092.85
355662-5566296.05396.05
452981-5298191.42691.43
555514-5551495.79795.80
653576-5357692.45392.45
10min155855-5585596.38694.951.8696.5595.111.86
254504-5450494.05494.21
355342-5534295.50195.66
453427-5342792.19692.35
556255-5625597.07697.24
654759-5475994.49594.65
15min155728-5572896.16794.931.7996.4995.241.80
254895-5489594.72995.04
355665-5566596.05896.38
453422-5342292.18792.49
555982-5598296.60596.93
654367-5436793.81894.13
20min156196-5619696.97494.942.0797.4695.412.07
255045-5504594.98895.46
355453-5545395.69296.17
453420-5342092.18492.64
556070-5607096.75797.24
653910-5391093.02993.50
30min155827-5582796.33894.441.8996.9895.071.89
254600-5460094.22094.85
354773-5477394.51995.16
453348-5334892.06092.67
555929-5592996.51497.16
653871-5387192.96293.59
45min155949-5594996.54894.861.9097.3595.651.89
254803-5480394.57095.36
355681-5568196.08696.88
453348-5334892.06092.83
555828-5582896.33997.14
654233-5423393.58794.36
极限155929-5592996.51494.512.1697.4895.462.16
254921-5492194.77495.72
355465-5546595.71396.67
452817-5281791.14392.06
555542-5554295.84696.81
653937-5393793.07694.01
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%
110.078635285986862838629286343862510.18
210.088651886471864940.04
单位质量响应值RSD%判断
8565.148580.750.13数据可信
长期3月-供试品溶液-2024010421批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195027-9502799.56198.791.0999.5698.791.09
293182-9318297.62897.63
394508-9450899.01799.02
494423-9442398.92898.93
592997-9299797.43497.43
695586-95586100.147100.15
10min196440-96440101.04299.521.34101.2199.691.34
293708-9370898.17998.34
394990-9499099.52299.69
494817-9481799.34199.51
593535-9353597.99898.16
696449-96449101.051101.22
15min196261-96261100.85499.341.35101.1999.671.35
293550-9355098.01498.34
394812-9481299.33699.67
494854-9485499.38099.71
593209-9320997.65697.98
696198-96198100.788101.12
20min195851-95851100.42599.071.33100.9399.571.32
293349-9334997.80398.29
394523-9452399.03399.53
494653-9465399.16999.67
592971-9297197.40797.90
696018-96018100.600101.10
30min195774-95774100.34498.841.26101.0199.501.26
293300-9330097.75298.40
394401-9440198.90599.57
493984-9398498.46899.13
592913-9291397.34698.00
695645-95645100.209100.88
45min195591-95591100.15298.671.30100.9999.501.30
292929-9292997.36398.18
394115-9411598.60699.43
494199-9419998.69499.52
592734-9273497.15997.97
695497-95497100.054100.89
极限195028-9502899.56298.371.37100.5799.361.37
292667-9266797.08998.07
393957-9395798.44099.43
493777-9377798.25299.24
592312-9231296.71797.69
695612-95612100.174101.18
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%
114.715379253753539515388053754538260.17
214.695391553818538660.13
单位质量响应值RSD%判断
3659.143666.850.15数据可信
长期3月-供试品溶液-2024010421批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154648-5464894.19593.991.6894.2093.991.68
253586-5358692.36592.36
355531-5553195.71795.72
454677-5467794.24594.25
553314-5331491.89691.90
655413-5541395.51495.51
10min155549-5554995.74895.282.8195.9195.432.81
252745-5274590.91591.07
356491-5649197.37297.53
455825-5582596.22496.38
554163-5416393.35993.51
656877-5687798.03798.20
15min155470-5547095.61295.871.5895.9396.191.58
255431-5543195.54595.85
356620-5662097.59497.92
455747-5574796.09096.41
554123-5412393.29093.60
656339-5633997.11097.43
20min154707-5470794.29795.222.4894.7795.692.48
253843-5384392.80893.27
356429-5642997.26597.75
455779-5577996.14596.62
553702-5370292.56593.03
656985-5698598.22398.71
30min155015-5501594.82895.431.8395.4696.061.83
254324-5432493.63794.26
356197-5619796.86597.51
455502-5550295.66796.31
554329-5432993.64594.26
656812-5681297.92598.57
45min155257-5525795.24595.932.0096.0496.721.99
255287-5528795.29796.07
356552-5655297.47798.29
455740-5574096.07796.87
553963-5396393.01593.79
657128-5712898.47099.28
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