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%
19.868227782427821198238682251822920.15
29.958236382247823050.10
单位质量响应值RSD%判断
8346.048271.860.64数据可信
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%
5min190960-9096098.33098.372.9198.3398.372.91
292523-92523100.020100.02
385916-8591692.87792.88
491096-9109698.47798.48
592138-9213899.60399.60
693330-93330100.892100.89
10min192374-9237499.859100.602.39100.02100.762.39
294948-94948102.641102.81
389290-8929096.52596.68
492655-92655100.162100.33
593617-93617101.202101.37
695473-95473103.209103.38
15min192675-92675100.184100.742.25100.51101.072.25
295253-95253102.971103.31
389662-8966296.92797.24
492656-92656100.163100.49
593627-93627101.213101.55
695280-95280103.000103.34
20min192679-92679100.188100.782.17100.69101.282.17
295345-95345103.070103.58
389916-8991697.20197.68
492680-92680100.189100.69
593437-93437101.008101.51
695280-95280103.000103.51
30min192552-92552100.051100.552.01100.72101.212.01
294968-94968102.663103.34
389867-8986797.14897.79
492422-9242299.910100.58
593552-93552101.132101.80
694698-94698102.371103.05
45min192470-9247099.962100.402.20100.79101.232.19
295187-95187102.899103.75
389530-8953096.78497.59
492122-9212299.586100.42
593225-93225100.778101.62
694696-94696102.369103.22
极限192517-92517100.013100.162.05101.01101.172.05
294932-94932102.624103.65
389512-8951296.76597.73
491985-9198599.438100.44
592803-92803100.322101.33
694189-94189101.821102.85
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%
113.784852248243484834820948166483250.35
213.834842648237483320.28
单位质量响应值RSD%判断
3506.893494.720.25数据可信
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%
5min151196-5119692.33495.592.2392.3395.592.24
253287-5328796.10596.10
353309-5330996.14496.14
452041-5204193.85893.86
553722-5372296.88996.89
654452-5445298.20698.21
10min153275-5327596.08398.882.4896.2499.042.48
254551-5455198.38498.54
355829-55829100.689100.85
453475-5347596.44496.60
556789-56789102.421102.58
655021-5502199.23299.40
15min153458-5345896.41398.802.1596.7399.132.14
255948-55948100.904101.23
355697-55697100.451100.78
453302-5330296.13296.45
554650-5465098.56398.90
655634-55634100.338100.67
20min153271-5327196.07698.892.7496.5599.372.74
254376-5437698.06998.56
355107-5510799.38799.88
453226-5322695.99596.47
556047-56047101.083101.58
656947-56947102.706103.20
30min153791-5379197.01497.751.5197.6598.401.52
253988-5398897.36998.02
355011-5501199.21499.88
452867-5286795.34795.98
554921-5492199.05299.72
654615-5461598.50099.17
45min153453-5345396.40497.752.0197.2098.572.01
254592-5459298.45899.28
354496-5449698.28599.11
452423-5242394.54795.34
554776-5477698.79099.62
655464-55464100.031100.86
极限153189-5318995.92896.981.6196.8997.961.61
253741-5374196.92497.91
354626-5462698.52099.51
452474-5247494.63895.59
553846-5384697.11398.11
654754-5475498.75199.75
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%
19.868190282097818788189482032819610.12
29.958217282119821460.05
单位质量响应值RSD%判断
8312.478255.880.49数据可信
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%
5min193759-93759101.658100.891.57101.66100.901.58
293301-93301101.161101.16
393113-93113100.958100.96
495234-95234103.257103.26
591098-9109898.77398.77
691824-9182499.56099.56
10min194058-94058101.982101.551.34102.15101.721.34
293411-93411101.281101.45
393396-93396101.264101.43
495900-95900103.979104.15
592212-9221299.981100.15
693005-93005100.841101.01
15min194352-94352102.301101.691.23102.64102.031.23
293644-93644101.533101.87
393812-93812101.716102.05
495669-95669103.729104.07
592465-92465100.255100.59
692808-92808100.627100.96
20min194004-94004101.924101.500.93102.43102.010.93
293651-93651101.541102.05
393195-93195101.047101.55
495111-95111103.124103.64
592644-92644100.449100.95
693097-93097100.940101.44
30min193994-93994101.913101.491.10102.59102.171.10
293458-93458101.332102.01
393265-93265101.122101.80
495454-95454103.496104.19
592706-92706100.516101.18
692748-92748100.562101.23
45min193296-93296101.156101.141.09102.01101.991.10
293130-93130100.976101.82
393164-93164101.013101.86
495186-95186103.205104.07
592182-9218299.948100.78
692751-92751100.565101.40
极限193062-93062100.902100.811.14101.92101.821.14
293086-93086100.928101.94
392786-92786100.603101.61
494890-94890102.884103.92
592111-9211199.871100.87
691920-9192099.664100.67
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%
113.784771048182476744823048312480220.64
213.834867147985483281.01
单位质量响应值RSD%判断
3484.913494.430.20数据可信
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%
5min152608-5260895.18395.470.7395.1895.470.73
252080-5208094.22894.23
352988-5298895.87095.87
452945-5294595.79395.79
553150-5315096.16496.16
652836-5283695.59595.60
10min154150-5415097.97398.440.9398.1398.600.93
253715-5371597.18697.34
355122-5512299.73199.89
454135-5413597.94698.11
554646-5464698.87099.03
654697-5469798.96399.12
15min154279-5427998.20698.471.6298.5398.801.62
253317-5331796.46696.78
355868-55868101.081101.41
453812-5381297.36197.68
554795-5479599.14099.46
654493-5449398.59398.92
20min154253-5425398.15998.301.1298.6498.781.12
253602-5360296.98197.46
355296-55296100.046100.54
453795-5379597.33197.82
554589-5458998.76799.26
654442-5444298.50198.99
30min154224-5422498.10798.171.0298.7698.821.01
253396-5339696.60997.25
354984-5498499.482100.14
454423-5442398.46799.11
554583-5458398.75699.41
653938-5393897.58998.24
45min153980-5398097.66598.781.2998.4899.601.29
253845-5384597.42198.22
355550-55550100.506101.33
454249-5424998.15298.96
555292-55292100.039100.86
654663-5466398.90199.72
极限153320-5332096.47197.531.1797.4598.511.16
252999-5299995.89096.86
354300-5430098.24499.24
454426-5442698.47299.45
554518-5451898.63999.62
653855-5385597.43998.42
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