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%
110.058595285984860418604386105860250.07
210.038581885796858070.02
单位质量响应值RSD%判断
8559.708555.030.04数据可信
长期12月-供试品溶液-2024110321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%
5min192077-9207796.64698.641.7896.6598.641.78
294743-9474399.44499.44
392912-9291297.52297.52
495355-95355100.087100.09
592606-9260697.20197.20
696164-96164100.936100.94
10min195284-95284100.01299.941.53100.17100.101.53
296184-96184100.957101.12
393410-9341098.04598.21
495953-95953100.714100.88
593514-9351498.15498.32
696928-96928101.738101.91
15min195600-95600100.344100.071.33100.67100.401.33
296278-96278101.055101.39
394092-9409298.76199.09
495981-95981100.744101.08
593471-9347198.10998.43
696607-96607101.401101.74
20min195836-95836100.592100.031.67101.09100.531.67
296701-96701101.499102.00
393141-9314197.76398.25
495917-95917100.677101.18
593500-9350098.14098.63
696723-96723101.523102.03
30min195992-95992100.75599.731.65101.42100.401.65
296161-96161100.933101.60
393021-9302197.63798.29
495585-95585100.328101.00
593013-9301397.62898.28
696320-96320101.100101.78
45min195705-95705100.45499.631.76101.28100.461.76
295692-95692100.440101.28
392682-9268297.28198.10
496253-96253101.029101.87
592921-9292197.53298.35
696285-96285101.063101.91
极限195300-95300100.02999.431.80101.03100.431.80
296055-96055100.821101.83
392453-9245397.04198.02
495948-95948100.709101.72
592669-9266997.26798.25
695972-95972100.734101.75
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%
113.764776047959479474798048064479420.24
213.724836748362483640.01
单位质量响应值RSD%判断
3484.163525.070.83数据可信
长期12月-供试品溶液-2024110321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%
5min151606-5160692.21094.411.2692.2194.411.26
252896-5289694.51594.52
353016-5301694.73094.73
453277-5327795.19695.20
552725-5272594.21094.21
653509-5350995.61195.61
10min154100-5410096.66797.001.2696.8297.161.26
253911-5391196.32996.49
354514-5451497.40697.56
453966-5396696.42796.59
553679-5367995.91496.07
655556-5555699.26899.43
15min153846-5384696.21397.291.1896.5397.611.18
254422-5442297.24297.56
354941-5494198.16998.49
453542-5354295.67095.99
554777-5477797.87698.19
655160-5516098.56198.89
20min153943-5394396.38697.290.5696.8697.770.56
254459-5445997.30897.79
354538-5453897.44997.93
454294-5429497.01397.49
554635-5463597.62398.10
654816-5481697.94698.44
30min154080-5408096.63196.820.3997.2797.470.39
253982-5398296.45697.10
354551-5455197.47398.12
454159-5415996.77297.41
554059-5405996.59397.24
654299-5429997.02297.67
45min154405-5440597.21297.941.1398.0198.741.13
253923-5392396.35097.15
354809-5480997.93498.74
454903-5490398.10298.90
555068-5506898.39699.20
655752-5575299.619100.43
极限154213-5421396.86997.511.1397.8398.481.13
253599-5359995.77196.74
354626-5462697.60798.58
454807-5480797.93098.90
554767-5476797.85898.83
655422-5542299.029100.01
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%
110.058637586308863188630886297863210.04
210.038601786034860260.02
单位质量响应值RSD%判断
8589.158576.870.11数据可信
长期12月-供试品溶液-2024110421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%
5min192295-9229596.58597.912.7796.5997.912.77
296186-96186100.657100.66
389401-8940193.55793.56
495439-9543999.87699.88
595389-9538999.82399.82
692631-9263196.93796.94
10min193403-9340397.74599.062.6197.9199.222.61
297150-97150101.666101.83
390721-9072194.93895.09
496521-96521101.008101.17
596345-96345100.824100.99
693819-9381998.18098.34
15min193129-9312997.45898.982.6397.7899.312.63
297252-97252101.773102.11
390791-9079195.01295.33
496591-96591101.081101.42
596118-96118100.586100.92
693636-9363697.98998.31
20min193964-9396498.33298.992.6598.8299.482.65
297132-97132101.647102.15
390517-9051794.72595.20
496575-96575101.064101.57
596077-96077100.543101.05
693286-9328697.62398.11
30min192485-9248596.78498.472.7097.4399.132.70
296974-96974101.482102.16
390345-9034594.54595.18
496111-96111100.579101.25
595548-9554899.990100.66
693113-9311397.44198.09
45min192310-9231096.60198.242.6397.4199.062.62
296383-96383100.863101.71
390051-9005194.23795.03
495666-95666100.113100.95
595656-95656100.103100.94
693165-9316597.49698.31
极限191968-9196896.24398.012.7297.2298.992.72
295733-95733100.183101.20
389897-8989794.07695.02
496286-96286100.762101.77
595390-9539099.824100.83
692637-9263796.94397.92
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%
113.764848348418484664854548434484690.11
213.724857748584485800.02
单位质量响应值RSD%判断
3522.463540.820.37数据可信
长期12月-供试品溶液-2024110421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%
5min153119-5311994.18594.172.3094.1994.172.30
254452-5445296.54996.55
353369-5336994.62894.63
451023-5102390.46990.47
554084-5408495.89695.90
652621-5262193.30293.30
10min154383-5438396.42696.491.9496.5896.641.94
254818-5481897.19897.36
355316-5531698.08198.24
452530-5253093.14193.29
555357-5535798.15398.31
654099-5409995.92396.08
15min154402-5440296.46096.731.7096.7897.051.70
255463-5546398.34198.66
355261-5526197.98398.30
452856-5285693.71994.02
554582-5458296.77997.10
654768-5476897.10997.42
20min154131-5413195.97996.782.0696.4697.262.06
255557-5555798.50898.99
355061-5506197.62898.11
452543-5254393.16493.63
555418-5541898.26198.75
654789-5478997.14697.62
30min153781-5378195.35996.692.1996.0097.332.19
255613-5561398.60799.26
355237-5523797.94098.59
452567-5256793.20693.82
555534-5553498.46799.12
654457-5445796.55797.20
45min153956-5395695.66996.652.2996.4797.452.29
255302-5530298.05698.87
355264-5526497.98898.80
452232-5223292.61293.39
555507-5550798.41999.23
654798-5479897.16297.96
极限153846-5384695.47495.911.9996.4396.871.99
254834-5483497.22698.20
354798-5479897.16298.14
452060-5206092.30793.23
554788-5478897.14498.12
654214-5421496.12797.09
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