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%
19.808382883672839468376683723837870.13
29.888327883458833680.16
单位质量响应值RSD%判断
8549.698438.060.93数据可信
供试品溶液-2024110221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%
5min190621-9062195.83396.702.5595.8396.702.55
295647-95647101.148101.15
391072-9107296.31096.31
490298-9029895.49195.49
588848-8884893.95893.96
692138-9213897.43797.44
10min192406-9240697.72198.672.2897.8898.832.28
297053-97053102.635102.80
393609-9360998.99399.15
491835-9183597.11797.28
591032-9103296.26896.42
693866-9386699.26599.43
15min192956-9295698.30298.972.2198.6299.292.21
297325-97325102.923103.26
393596-9359698.97999.30
492301-9230197.61097.93
591318-9131896.57096.89
694029-9402999.43799.76
20min193849-9384999.24799.202.0899.7399.692.09
297309-97309102.906103.42
393622-9362299.00799.50
492200-9220097.50397.99
591785-9178597.06497.54
694037-9403799.44599.94
30min194292-9429299.71599.322.10100.3799.982.10
297339-97339102.937103.62
393596-9359698.97999.63
492503-9250397.82398.47
591601-9160196.86997.51
694206-9420699.624100.28
45min194605-94605100.04699.502.02100.86100.322.02
297325-97325102.923103.78
393655-9365599.04199.86
492430-9243097.74698.56
592064-9206497.35998.16
694436-9443699.867100.69
极限194377-9437799.80599.452.00100.79100.442.01
297287-97287102.882103.91
393617-9361799.00199.99
492333-9233397.64398.62
592117-9211797.41598.38
694530-9453099.967100.96
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%
113.925030749988501485022650453502240.35
213.885024750281502640.05
单位质量响应值RSD%判断
3608.053621.330.26数据可信
供试品溶液-2024110221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%
5min135007-3500761.14760.092.7761.1560.092.77
235618-3561862.21462.21
333018-3301857.67357.67
433632-3363258.74558.75
534323-3432359.95259.95
634823-3482360.82660.83
10min147765-4776583.43281.272.3283.5381.372.32
247326-4732682.66582.77
345678-4567879.78679.88
444929-4492978.47878.58
546357-4635780.97281.07
647100-4710082.27082.37
15min149636-4963686.70085.333.9286.9485.573.91
250892-5089288.89489.14
348206-4820684.20284.43
448787-4878785.21785.45
545469-4546979.42179.66
650126-5012687.55687.79
20min151645-5164590.20987.932.7990.5988.302.78
252050-5205090.91691.31
348946-4894685.49585.86
448826-4882685.28585.66
549597-4959786.63287.00
650962-5096289.01689.40
30min151952-5195290.74588.922.5891.2889.442.58
252248-5224891.26291.80
349473-4947386.41586.93
449814-4981487.01187.52
549874-4987487.11687.63
652072-5207290.95591.49
45min152709-5270992.06790.202.3592.7590.872.36
253204-5320492.93293.63
350439-5043988.10288.76
450176-5017687.64388.30
551346-5134689.68790.34
651952-5195290.74591.43
极限153966-5396694.26392.861.0995.1093.681.10
253622-5362293.66294.51
352630-5263091.92992.73
452718-5271892.08392.89
552649-5264991.96392.77
653396-5339693.26794.10
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%
19.808364983655836848359183626836410.05
29.888377983740837600.04
单位质量响应值RSD%判断
8534.808477.730.48数据可信
供试品溶液-2024110221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%
5min190370-9037095.42595.233.5795.4395.233.57
292626-9262697.80797.81
384318-8431889.03589.03
490016-9001695.05195.05
590242-9024295.29095.29
693551-9355198.78498.78
10min192246-9224697.40698.341.5297.5798.501.53
294287-9428799.56199.72
392364-9236497.53197.68
491248-9124896.35296.51
593625-9362598.86299.02
695006-95006100.321100.49
15min192364-9236497.53199.741.7597.85100.061.74
294327-9432799.60499.93
393800-9380099.04799.36
497391-97391102.839103.16
594175-9417599.44399.77
694671-9467199.967100.30
20min196163-96163101.54299.401.81102.0399.881.80
294342-9434299.619100.11
394035-9403599.29599.77
491049-9104996.14296.63
594248-9424899.520100.01
694948-94948100.259100.76
30min193475-9347598.70499.651.2699.36100.301.25
294353-9435399.631100.29
395499-95499100.841101.48
492521-9252197.69798.35
594882-94882100.190100.84
695498-95498100.840101.51
45min193765-9376599.01099.501.8299.83100.321.81
294072-9407299.334100.16
395973-95973101.342102.15
491214-9121496.31697.13
594656-9465699.951100.77
695666-95666101.018101.85
极限193368-9336898.59199.231.8799.57100.221.86
294023-9402399.283100.28
395625-95625100.974101.95
490815-9081595.89596.87
594653-9465399.948100.94
695347-95347100.681101.68
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%
113.925097849985499184954351351503551.53
213.885014050101501200.06
单位质量响应值RSD%判断
3617.463610.950.13数据可信
供试品溶液-2024110221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%
5min141285-4128572.12271.581.9572.1271.581.95
240137-4013770.11770.12
341460-4146072.42872.43
441454-4145472.41872.42
539808-3980869.54269.54
641718-4171872.87972.88
10min148071-4807183.97784.701.7584.1084.821.75
247951-4795183.76883.88
349760-4976086.92887.05
447791-4779183.48883.61
547981-4798183.82083.94
649357-4935786.22486.35
15min150231-5023187.75188.231.5188.0188.491.51
250281-5028187.83888.09
350449-5044988.13188.40
451044-5104489.17189.43
549401-4940186.30186.56
651629-5162990.19390.46
20min149991-4999187.33189.141.4987.7489.551.49
250650-5065088.48388.89
351829-5182990.54290.95
451183-5118389.41489.82
550591-5059188.38088.78
651921-5192190.70391.12
30min150474-5047488.17591.032.4488.7391.592.43
252029-5202990.89291.44
352950-5295092.50193.06
451960-5196090.77191.33
551194-5119489.43389.98
654056-5405694.43395.00
45min152279-5227991.32892.381.4892.0393.091.47
251894-5189490.65691.36
354127-5412794.55795.27
453143-5314392.83893.55
552742-5274292.13792.83
653109-5310992.77893.50
极限152137-5213791.08094.082.0091.9394.951.98
255208-5520896.44597.30
354278-5427894.82095.70
453647-5364793.71894.58
553332-5333293.16894.02
654539-5453995.27696.16
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%
19.808364683718836218381083827837240.12
29.888387483897838860.02
单位质量响应值RSD%判断
8543.278490.490.44数据可信
供试品溶液-2024110321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%
5min183840-8384088.42096.244.2588.4296.244.24
292494-9249497.54697.55
394721-9472199.89599.89
493383-9338398.48498.48
590633-9063395.58495.58
692450-9245097.50097.50
10min188172-8817292.98898.803.0893.1498.963.08
293602-9360298.71598.88
396093-96093101.342101.51
495780-95780101.012101.18
593934-9393499.06599.22
694528-9452899.69199.85
15min190119-9011995.04299.352.3295.3499.682.33
293883-9388399.01199.34
396041-96041101.287101.62
496022-96022101.267101.60
594523-9452399.686100.01
694660-9466099.831100.16
20min191843-9184396.86099.681.6197.32100.171.62
293679-9367998.79699.29
395540-95540100.759101.26
495963-95963101.205101.71
595078-95078100.271100.76
694974-94974100.162100.66
30min193487-9348798.593100.151.1899.22100.801.18
293691-9369198.80999.47
395808-95808101.041101.71
496045-96045101.291101.96
595661-95661100.886101.54
695077-95077100.270100.93
45min193798-9379898.921100.161.0599.71100.991.05
293705-9370598.82399.64
395574-95574100.794101.64
495646-95646100.870101.71
596006-96006101.250102.08
695117-95117100.313101.14
极限193605-9360598.71899.961.1499.67100.951.14
293348-9334898.44799.43
395446-95446100.659101.67
495480-95480100.695101.70
595959-95959101.200102.20
694845-94845100.026101.02
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%
113.925022150297501605056350437503360.33
213.884988850512502000.88
单位质量响应值RSD%判断
3616.093616.710.02数据可信
供试品溶液-2024110321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%
5min145367-4536779.20576.563.4179.2176.563.41
245509-4550979.45379.45
342567-4256774.31774.32
442950-4295074.98574.99
542099-4209973.50073.50
644617-4461777.89677.90
10min151017-5101789.06987.942.5389.2088.062.53
251800-5180090.43690.57
348771-4877185.14885.27
449427-4942786.29386.42
549582-4958286.56486.69
651614-5161490.11290.24
15min153296-5329693.04890.932.8093.3391.202.80
254041-5404194.34994.63
350766-5076688.63188.90
451578-5157890.04990.32
550304-5030487.82588.09
652498-5249891.65591.94
20min153773-5377393.88191.722.8194.3292.142.81
254292-5429294.78795.23
350919-5091988.89889.31
452213-5221391.15791.58
550787-5078788.66889.08
653216-5321692.90993.34
30min154363-5436394.91193.102.7995.5093.682.79
254551-5455195.23995.84
352128-5212891.00991.57
453590-5359093.56294.13
550923-5092388.90589.47
654401-5440194.97795.57
45min154579-5457995.28894.441.6596.0495.171.66
255301-5530196.54997.31
353308-5330893.06993.78
454108-5410894.46695.19
552845-5284592.26192.97
654406-5440694.98695.73
极限154968-5496895.96794.122.0596.8895.012.06
254747-5474795.58296.50
353526-5352693.45094.32
453847-5384794.01094.89
551945-5194590.69091.55
654416-5441695.00495.91
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%
19.808398683894838528397383877839160.08
29.888417783972840740.18
单位质量响应值RSD%判断
8562.868509.510.45数据可信
供试品溶液-2024110321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%
5min195536-95536100.52696.323.84100.5396.333.84
289712-8971294.39894.40
392437-9243797.26697.27
494827-9482799.78099.78
586058-8605890.55390.55
690689-9068995.42695.43
10min197353-97353102.43899.633.10102.6199.793.10
291966-9196696.77096.93
394497-9449799.43399.60
496894-96894101.955102.12
590402-9040295.12495.28
696987-96987102.053102.21
15min197409-97409102.497100.022.75102.84100.352.75
292849-9284997.69998.02
394959-9495999.919100.25
497178-97178102.254102.59
591083-9108395.84196.15
696851-96851101.910102.24
20min196699-96699101.750100.002.33102.26100.492.34
293608-9360898.49898.98
394722-9472299.670100.16
497197-97197102.274102.78
591467-9146796.24596.71
696506-96506101.547102.05
30min197124-97124102.197100.422.13102.88101.082.14
294598-9459899.539100.19
394904-9490499.861100.52
497355-97355102.441103.12
592011-9201196.81797.45
696616-96616101.663102.33
45min196695-96695101.746100.521.91102.60101.351.92
294798-9479899.750100.56
394822-9482299.775100.60
497123-97123102.196103.04
592552-9255297.38798.18
697216-97216102.294103.13
极限196544-96544101.587100.251.97102.61101.251.98
294717-9471799.665100.64
394375-9437599.305100.30
496825-96825101.883102.90
592190-9219097.00697.96
696991-96991102.057103.07
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%
113.925027550391503825059550241503770.28
213.884953551334504342.53
单位质量响应值RSD%判断
3619.043633.570.29数据可信
供试品溶液-2024110321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%
5min142692-4269274.33274.951.9074.3374.951.90
242329-4232973.70073.70
342796-4279674.51374.51
443350-4335075.47775.48
542551-4255174.08674.09
644556-4455677.57777.58
10min150136-5013687.29386.803.0387.4286.923.03
248691-4869184.77784.90
347610-4761082.89583.02
450614-5061488.12588.25
550145-5014587.30887.43
651913-5191390.38790.52
15min152622-5262291.62190.111.8891.8990.381.88
251101-5110188.97389.24
350779-5077988.41288.67
451084-5108488.94389.22
551728-5172890.06590.33
653215-5321592.65492.93
20min151709-5170990.03189.941.5690.4590.361.55
252037-5203790.60391.01
351736-5173690.07890.49
450146-5014687.31087.73
551764-5176490.12790.55
652535-5253591.47091.90
30min153682-5368293.46792.731.0594.0493.301.05
252971-5297192.22992.79
352355-5235591.15691.72
453363-5336392.91193.48
553239-5323992.69593.26
653932-5393293.90294.49
45min153954-5395493.94093.221.7894.6793.941.77
253218-5321892.65993.38
352843-5284392.00692.72
452529-5252991.45992.18
553500-5350093.15093.87
655186-5518696.08596.83
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