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%
19.808384983865835488383883560837320.20
29.888365283585836180.06
单位质量响应值RSD%判断
8544.088463.360.68数据可信
供试品溶液-2024110421批-比索洛尔-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%
5min190970-9097096.08994.945.8296.0994.945.82
292154-9215497.33997.34
387409-8740992.32792.33
480507-8050785.03785.04
594225-9422599.52799.53
694030-9403099.32199.32
10min193405-9340598.66198.054.2898.8298.204.28
294000-9400099.28999.45
393219-9321998.46498.62
485079-8507989.86690.01
596390-96390101.814101.98
694843-94843100.180100.35
15min194156-9415699.45499.033.4499.7899.353.45
294655-9465599.981100.31
394886-94886100.225100.54
487443-8744392.36392.65
596773-96773102.218102.55
694599-9459999.922100.25
20min194281-9428199.58699.602.93100.08100.092.94
294811-94811100.146100.64
395523-95523100.898101.38
489156-8915694.17394.62
597434-97434102.916103.42
694557-9455799.877100.38
30min194675-94675100.002100.212.45100.66100.872.46
294830-94830100.166100.83
396414-96414101.839102.49
490902-9090296.01796.62
597824-97824103.328104.01
694605-9460599.928100.59
45min194874-94874100.212100.522.09101.04101.342.10
294898-94898100.238101.07
396609-96609102.045102.87
492170-9217097.35698.12
597983-97983103.496104.35
694470-9447099.786100.62
极限194855-94855100.192100.672.00101.18101.662.01
294849-94849100.186101.18
396920-96920102.373103.37
492778-9277897.99898.92
598089-98089103.608104.63
694361-9436199.670100.67
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%
113.925034050096495344921649657497690.91
213.884949449954497240.66
单位质量响应值RSD%判断
3575.363582.420.14数据可信
供试品溶液-2024110421批-左氨氯地平-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%
5min133397-3339758.91858.643.7858.9258.643.78
230968-3096854.63354.63
334399-3439960.68660.69
433512-3351259.12159.12
532862-3286257.97457.97
634296-3429660.50460.50
10min146350-4635081.77080.611.6781.8780.711.66
244641-4464178.75578.85
346227-4622781.55381.65
446136-4613681.39281.49
544815-4481579.06279.16
645988-4598881.13181.23
15min149774-4977487.81085.352.7088.0485.582.70
245943-4594381.05281.27
348961-4896186.37686.61
448514-4851485.58785.82
548859-4885986.19686.42
648213-4821385.05685.29
20min149688-4968887.65986.332.4988.0486.712.49
246548-4654882.11982.48
349218-4921886.82987.21
449537-4953787.39287.77
549769-4976987.80188.17
648863-4886386.20386.58
30min150184-5018488.53488.342.8189.0688.852.81
247535-4753583.86084.35
351808-5180891.39991.92
450511-5051189.11089.63
549881-4988187.99988.52
650515-5051589.11889.64
45min150832-5083289.67789.653.0390.3590.323.02
248166-4816684.97385.61
352488-5248892.59893.28
452029-5202991.78892.46
550216-5021688.59089.26
651185-5118590.30090.97
极限152516-5251692.64893.191.1393.4794.011.13
252037-5203791.80392.58
353495-5349594.37595.21
452749-5274993.05993.88
552601-5260192.79893.61
653557-5355794.48495.30
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%
19.808353683545835858355883594835640.04
29.888349183621835560.12
单位质量响应值RSD%判断
8526.948457.090.59数据可信
供试品溶液-2024110421批-比索洛尔-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%
5min197206-97206102.81797.873.19102.8297.873.19
289919-8991995.10995.11
391856-9185697.15897.16
489605-8960594.77794.78
594795-94795100.266100.27
691777-9177797.07497.07
10min197039-97039102.64099.772.21102.8199.942.21
291774-9177497.07197.23
394425-9442599.875100.04
492161-9216197.48097.64
596082-96082101.628101.79
694488-9448899.942100.10
15min197356-97356102.975100.331.78103.32100.661.79
293713-9371399.12299.44
394408-9440899.857100.19
492626-9262697.97298.29
596066-96066101.611101.95
694946-94946100.426100.75
20min197520-97520103.149100.351.78103.66100.851.78
293420-9342098.81299.30
394342-9434299.787100.28
493004-9300498.37298.86
596022-96022101.564102.07
694945-94945100.425100.92
30min197391-97391103.012100.771.45103.70101.441.46
294445-9444599.896100.55
394365-9436599.812100.47
493696-9369699.10499.75
596258-96258101.814102.49
695499-95499101.011101.67
45min197431-97431103.055100.821.35103.91101.651.36
294617-94617100.078100.89
394215-9421599.653100.48
494174-9417499.610100.42
596194-96194101.746102.59
695301-95301100.802101.63
极限196693-96693102.274101.481.52103.30102.481.52
295138-95138100.629101.61
398132-98132103.796104.79
493845-9384599.262100.24
596233-96233101.787102.80
695606-95606101.124102.12
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%
113.924962549506493454965249640495540.27
213.884976949653497110.17
单位质量响应值RSD%判断
3559.913581.480.43数据可信
供试品溶液-2024110421批-左氨氯地平-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%
5min140209-4020971.09971.611.2371.1071.611.23
239762-3976270.30970.31
341185-4118572.82572.82
440682-4068271.93671.94
540783-4078372.11472.11
640359-4035971.36471.36
10min149837-4983788.12485.472.8788.2485.592.86
247675-4767584.30184.42
350197-5019788.76088.88
447759-4775984.44984.57
547923-4792384.73984.86
646633-4663382.45882.58
15min152111-5211192.14588.762.6892.4189.022.67
249525-4952587.57287.83
351476-5147691.02291.29
448505-4850585.76986.03
549900-4990088.23588.50
649661-4966187.81388.07
20min152775-5277593.31989.753.0093.7490.163.00
249277-4927787.13487.54
352545-5254592.91293.33
449659-4965987.80988.21
550424-5042489.16289.57
649859-4985988.16388.57
30min151197-5119790.52990.032.3591.1090.592.35
250690-5069089.63290.18
352756-5275693.28593.86
450702-5070289.65390.20
551104-5110490.36490.92
649038-4903886.71187.26
45min150851-5085189.91790.852.1890.6491.562.18
250160-5016088.69589.39
353369-5336994.36995.10
450807-5080789.83990.54
551826-5182691.64192.35
651258-5125890.63691.33
极限152363-5236392.59092.691.6493.4793.551.62
252412-5241292.67793.52
351092-5109290.34391.23
451964-5196491.88592.73
553216-5321694.09994.96
653462-5346294.53495.38
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