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%
19.948230982282831228211681871823400.58
210.058213582369822520.21
单位质量响应值RSD%判断
8283.708184.280.86数据可信
供试品溶液-2024110221批-比索洛尔-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188605-8860596.65896.122.4396.6696.122.44
289483-8948397.61697.62
389024-8902497.11597.11
483851-8385191.47291.47
589442-8944297.57197.57
688273-8827396.29696.30
10min191676-91676100.00899.211.82100.1799.371.82
292033-92033100.397100.56
392192-92192100.571100.73
487983-8798395.97996.13
591796-91796100.139100.30
689993-8999398.17298.33
15min191940-91940100.29699.671.68100.6299.991.68
292409-92409100.807101.14
392317-92317100.707101.04
488760-8876096.82797.14
592511-92511100.919101.25
690235-9023598.43698.76
20min192012-92012100.37499.801.54100.87100.291.54
292163-92163100.539101.04
392508-92508100.915101.41
489167-8916797.27197.74
592671-92671101.093101.59
690366-9036698.57999.07
30min192025-92025100.38999.991.41101.05100.651.41
292410-92410100.809101.47
392624-92624101.042101.71
489694-8969497.84698.48
592787-92787101.220101.89
690424-9042498.64299.29
45min191680-91680100.01299.831.50100.84100.651.50
291970-91970100.329101.16
392595-92595101.010101.84
489420-8942097.54798.35
593020-93020101.474102.31
690366-9036698.57999.40
极限191590-9159099.91499.851.45100.91100.841.45
292287-92287100.674101.68
392613-92613101.030102.03
489628-8962897.77498.74
592821-92821101.257102.26
690228-9022898.42899.41
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%
113.224994649729496474930749437496130.51
213.254980949860498340.08
单位质量响应值RSD%判断
3752.873761.060.16数据可信
供试品溶液-2024110221批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123632-2363239.71540.749.0939.7140.749.09
225284-2528442.49142.49
328033-2803347.11147.11
422015-2201536.99837.00
522389-2238937.62637.63
624086-2408640.47840.48
10min142640-4264071.65972.744.7771.7372.814.78
245381-4538176.26576.34
345704-4570476.80876.89
440424-4042467.93568.00
541796-4179670.24170.30
643747-4374773.51973.59
15min149571-4957183.30780.942.9883.4981.122.99
249873-4987383.81584.01
348643-4864381.74781.95
446484-4648478.11978.29
546719-4671978.51478.69
647671-4767180.11480.30
20min150218-5021884.39483.181.8184.7283.501.81
250621-5062185.07285.41
348854-4885482.10282.44
448172-4817280.95681.26
549689-4968983.50583.82
649417-4941783.04883.37
30min151151-5115185.96283.762.3186.4384.222.30
251373-5137386.33586.81
349559-4955983.28783.77
449132-4913282.56983.01
549217-4921782.71283.16
648598-4859881.67282.13
45min151531-5153186.60184.002.2687.2184.602.25
250750-5075085.28885.91
349691-4969183.50984.13
448198-4819881.00081.58
549719-4971983.55684.14
649998-4999884.02584.62
极限151397-5139786.37684.902.1487.1385.642.14
251455-5145586.47387.24
350938-5093885.60486.36
448528-4852881.55482.27
550439-5043984.76685.49
650364-5036484.64085.38
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%
19.948228582227823208228782282822800.05
210.058231482117822160.17
单位质量响应值RSD%判断
8277.678180.700.84数据可信
供试品溶液-2024110421批-比索洛尔-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186745-8674594.68495.163.5994.6895.163.59
282877-8287790.46290.46
388718-8871896.83796.84
490071-9007198.31498.31
584216-8421691.92391.92
690456-9045698.73498.73
10min189748-8974897.96297.572.9898.1297.722.98
286226-8622694.11794.27
390637-9063798.93299.09
491468-9146899.839100.00
586012-8601293.88494.04
692219-92219100.659100.82
15min190797-9079799.10798.482.7899.4398.802.78
287836-8783695.87596.18
390363-9036398.63398.96
492506-92506100.972101.30
586759-8675994.69995.01
693052-93052101.568101.90
20min191287-9128799.64298.842.48100.1399.332.48
288153-8815396.22196.69
390815-9081599.12699.62
492631-92631101.109101.61
587546-8754695.55896.03
692891-92891101.392101.89
30min192026-92026100.44899.582.14101.10100.232.15
289896-8989698.12398.75
391524-9152499.900100.56
492849-92849101.346102.01
588000-8800096.05496.68
693088-93088101.607102.28
45min192063-92063100.48999.811.83101.31100.631.84
290653-9065398.95099.74
391195-9119599.541100.36
492758-92758101.247102.08
588679-8867996.79597.58
693309-93309101.849102.69
极限192790-92790101.28299.762.08102.27100.742.08
290678-9067898.97799.93
391150-9115099.492100.48
492435-92435100.895101.90
588083-8808396.14497.09
693250-93250101.784102.79
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%
113.224999149798494084971849414496660.51
213.254947149356494140.17
单位质量响应值RSD%判断
3756.883729.360.52数据可信
供试品溶液-2024110421批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124750-2475041.74846.4712.4541.7546.4712.45
233859-3385957.11357.11
328548-2854848.15548.15
426775-2677545.16445.16
526823-2682345.24545.24
624541-2454141.39641.40
10min134973-3497358.99261.334.3759.0661.404.36
236014-3601460.74860.84
337918-3791863.96064.04
437502-3750263.25863.33
537645-3764563.49963.57
634093-3409357.50857.58
15min138612-3861265.13169.533.8265.3069.713.82
241830-4183070.55970.76
340680-4068068.61968.81
442768-4276872.14172.32
542720-4272072.06072.24
640717-4071768.68168.85
20min142421-4242171.55673.943.4471.8374.243.44
242295-4229571.34371.66
345540-4554076.81777.12
444522-4452275.10075.40
545432-4543276.63576.94
642802-4280272.19872.48
30min144453-4445374.98378.033.5075.3878.453.50
246956-4695679.20579.64
347801-4780180.63181.06
447119-4711979.48079.91
547259-4725979.71680.15
643977-4397774.18074.58
45min146185-4618577.90580.133.9578.4380.683.94
248305-4830581.48182.05
348689-4868982.12882.69
448435-4843581.70082.26
549114-4911482.84583.41
644299-4429974.72375.25
极限148384-4838481.61479.775.2182.2680.455.14
246296-4629678.09278.79
344855-4485575.66176.36
449414-4941483.35184.05
544434-4443474.95175.65
650371-5037184.96685.61
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%
19.948232682255823248242282231823120.10
210.058228882265822760.02
单位质量响应值RSD%判断
8280.898186.670.81数据可信
供试品溶液-2024110421批-比索洛尔-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183442-8344291.02892.861.2391.0392.861.23
286408-8640894.26394.26
385543-8554393.32093.32
485854-8585493.65993.66
584819-8481992.53092.53
684688-8468892.38792.39
10min186579-8657994.45095.921.3094.6096.071.30
289821-8982197.98698.14
387473-8747395.42595.58
488664-8866496.72496.88
587446-8744695.39695.55
687563-8756395.52395.68
15min187934-8793495.92896.820.9396.2497.130.93
290302-9030298.51198.83
388532-8853296.58096.89
488937-8893797.02297.34
588452-8845296.49396.81
688350-8835096.38296.69
20min188526-8852696.57497.540.9097.0498.020.90
290586-9058698.82199.31
389028-8902897.12197.60
490200-9020098.40098.88
589195-8919597.30497.78
688961-8896197.04897.52
30min188895-8889596.97698.200.9397.6198.840.93
290940-9094099.20799.86
389556-8955697.69798.33
490957-9095799.22699.87
589565-8956597.70798.34
690208-9020898.40999.04
45min189503-8950397.64098.401.0698.4399.201.06
290951-9095199.219100.03
389090-8909097.18997.99
491557-9155799.880100.69
589633-8963397.78198.58
690454-9045498.67799.48
极限189791-8979197.95498.761.0998.9199.731.09
291662-9166299.995100.97
389601-8960197.74698.71
491720-91720100.058101.03
589687-8968797.84098.80
690737-9073798.98699.95
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%
113.224931749732492874949049742495140.45
213.254950849988497480.69
单位质量响应值RSD%判断
3745.393754.570.18数据可信
供试品溶液-2024110421批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126113-2611343.96645.234.2043.9745.234.20
225717-2571743.30043.30
328155-2815547.40447.40
427224-2722445.83745.84
525837-2583743.50243.50
628132-2813247.36647.37
10min135587-3558759.91862.493.6459.9962.563.65
235328-3532859.48159.55
338305-3830564.49464.57
438362-3836264.59064.67
537199-3719962.63262.70
637897-3789763.80763.89
15min140196-4019667.67869.674.4767.8569.854.47
239192-3919265.98766.16
343092-4309272.55472.74
441999-4199970.71370.90
540026-4002667.39167.57
643779-4377973.71073.90
20min143599-4359973.40776.004.4373.6976.304.43
242029-4202970.76471.05
346462-4646278.22878.54
447454-4745479.89880.20
545240-4524076.17076.46
646045-4604577.52677.83
30min145888-4588877.26179.534.1677.6779.954.16
244512-4451274.94575.34
346761-4676178.73179.17
449047-4904782.58083.02
547425-4742579.84980.27
649778-4977883.81184.25
45min148156-4815681.08081.493.0181.6282.043.01
246127-4612777.66478.19
348335-4833581.38181.95
449899-4989984.01584.59
547826-4782680.52481.07
650055-5005584.27784.85
极限147165-4716579.41181.802.9780.0882.492.98
246547-4654778.37179.02
348876-4887682.29283.00
450364-5036484.79785.51
549139-4913982.73583.42
649397-4939783.16983.89
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