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4000
标示量(mg)2.5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%
110.474294543075429784284042888429450.21
210.344313943197431680.10
单位质量响应值RSD%判断
4101.724174.851.25数据可信
供试品溶液-不脱气2024010321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%
5min143615-4361594.67296.532.0094.6796.532.00
244487-4448796.56596.56
344019-4401995.54995.55
443885-4388595.25895.26
544741-4474197.11697.12
646074-46074100.010100.01
10min143510-4351094.44496.602.2494.6096.762.24
244789-4478997.22097.38
343775-4377595.01995.18
443876-4387695.23995.40
544881-4488197.42097.58
646186-46186100.253100.42
15min143357-4335794.11296.112.2094.4396.442.20
244394-4439496.36396.69
343609-4360994.65994.98
443767-4376795.00295.32
544507-4450796.60896.93
646037-4603799.929100.26
20min143001-4300193.33995.522.0893.8196.002.08
244299-4429996.15796.64
343373-4337394.14794.62
443595-4359594.62995.10
544194-4419495.92996.41
645582-4558298.94299.44
30min143081-4308193.51395.171.9694.1495.811.96
243941-4394195.38096.02
343207-4320793.78794.42
443344-4334494.08494.72
544127-4412795.78496.43
645372-4537298.48699.15
45min142626-4262692.52594.392.1693.3195.192.16
243808-4380895.09195.89
342666-4266692.61293.40
442966-4296693.26394.05
543762-4376294.99195.80
645075-4507597.84198.67
极限142303-4230391.82493.661.9792.7694.621.97
243276-4327693.93694.90
342562-4256292.38693.33
442675-4267592.63293.58
543439-4343994.29095.25
644630-4463096.87597.87
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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.554844548742485304845348472485280.26
213.654852148599485600.12
单位质量响应值RSD%判断
3581.403557.510.48数据可信
供试品溶液-不脱气2024010321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%
5min154216-54216133.010134.251.94133.01134.251.94
253474-53474131.190131.19
354916-54916134.728134.73
456543-56543138.719138.72
554154-54154132.858132.86
655026-55026134.998135.00
10min155032-55032135.012134.021.18135.23134.251.18
255017-55017134.976135.19
354726-54726134.262134.49
455322-55322135.724135.96
553894-53894132.220132.44
653781-53781131.943132.17
15min154838-54838134.536134.221.25134.98134.671.25
254504-54504133.717134.16
354708-54708134.217134.67
455937-55937137.233137.69
554337-54337133.307133.75
653931-53931132.311132.76
20min153882-53882132.191132.921.84132.86133.591.83
254506-54506133.722134.39
354400-54400133.462134.13
455686-55686136.617137.30
553951-53951132.360133.02
652646-52646129.159129.82
30min153852-53852132.117131.601.44133.01132.491.43
253028-53028130.096130.99
353583-53583131.457132.35
454848-54848134.561135.47
553892-53892132.216133.10
652638-52638129.139130.02
45min153125-53125130.334130.541.35131.45131.651.35
252926-52926129.846130.95
353532-53532131.332132.45
454440-54440133.560134.70
552881-52881129.735130.84
652339-52339128.406129.50
极限153426-53426131.072129.391.54132.40130.721.53
252783-52783129.495130.82
353225-53225130.579131.91
453290-53290130.739132.10
552454-52454128.688130.01
651269-51269125.780127.09
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4000
标示量(mg)2.5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%
110.474384843612435464352243531436120.32
210.344349743213433550.47
单位质量响应值RSD%判断
4165.434192.940.47数据可信
供试品溶液-手动取样2024010321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%
5min143460-4346093.40695.961.6693.4195.961.66
244434-4443495.50095.50
345462-4546297.70997.71
445175-4517597.09297.09
544272-4427295.15195.15
645095-4509596.92096.92
10min143325-4332593.11695.851.8593.2796.011.85
244148-4414894.88595.04
345535-4553597.86698.03
445034-4503496.78996.95
544301-4430195.21495.37
645237-4523797.22697.39
15min142992-4299292.40094.831.7192.7195.151.71
243616-4361693.74294.06
344947-4494796.60296.93
444759-4475996.19896.52
543898-4389894.34894.66
644525-4452595.69596.02
20min142531-4253191.41093.751.7691.8794.221.77
243118-4311892.67193.14
344588-4458895.83196.32
444035-4403594.64295.13
543287-4328793.03493.51
644155-4415594.90095.38
30min141799-4179989.83692.791.9690.4593.431.96
242780-4278091.94592.57
344110-4411094.80395.45
443690-4369093.90194.54
542941-4294192.29192.92
643729-4372993.98494.63
45min141311-4131188.78891.611.8689.5592.401.86
242124-4212490.53591.32
343504-4350493.50194.31
443069-4306992.56693.36
542697-4269791.76692.55
643029-4302992.48093.28
极限140885-4088587.87290.501.8388.7991.441.83
241652-4165289.52090.45
342873-4287392.14593.11
442541-4254191.43192.38
541928-4192890.11491.05
642775-4277591.93492.89
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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.554867048519484204855348673485670.23
213.654811848702484100.86
单位质量响应值RSD%判断
3584.283546.520.75数据可信
供试品溶液-手动取样2024010321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%
5min154277-54277133.314129.133.88133.31129.133.88
253023-53023130.234130.23
354865-54865134.758134.76
451086-51086125.476125.48
549384-49384121.296121.30
652805-52805129.698129.70
10min155010-55010135.114133.391.24135.34133.601.24
253742-53742132.000132.22
355306-55306135.841136.07
454004-54004132.643132.85
553909-53909132.410132.61
653871-53871132.317132.53
15min154338-54338133.464131.141.69133.91131.581.69
253175-53175130.607131.04
354456-54456133.753134.20
452420-52420128.753129.18
553575-53575131.590132.01
652396-52396128.694129.13
20min153028-53028130.246129.511.91130.92130.171.91
252174-52174128.148128.80
354167-54167133.044133.72
451713-51713127.016127.66
553528-53528131.474132.12
651766-51766127.146127.80
30min151538-51538126.586128.011.75127.47128.881.74
252854-52854129.819130.69
353558-53558131.548132.44
452011-52011127.748128.60
551558-51558126.635127.50
651198-51198125.751126.61
45min151611-51611126.766126.151.87127.86127.241.86
251679-51679126.933128.02
352372-52372128.635129.75
449967-49967122.728123.80
552111-52111127.994129.07
650419-50419123.838124.91
极限151243-51243125.862124.471.75127.17125.761.74
251176-51176125.697126.99
350677-50677124.472125.80
450127-50127123.121124.39
551619-51619126.785128.07
649217-49217120.886122.16
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4000
标示量(mg)2.5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%
110.474413643901438354394043934439490.26
210.344367143719436950.08
单位质量响应值RSD%判断
4197.614225.820.48数据可信
供试品溶液-2024010321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%
5min145700-4570097.46295.162.3397.4695.162.33
244472-4447294.84394.84
344163-4416394.18494.18
442870-4287091.42791.43
544991-4499195.95095.95
645518-4551897.07497.07
10min146181-4618198.48895.782.4698.6595.942.46
244786-4478695.51395.67
344500-4450094.90395.06
443078-4307891.87092.02
545070-4507096.11896.28
645851-4585197.78497.95
15min146162-4616298.44795.682.2298.7796.002.21
244765-4476595.46895.79
344562-4456295.03595.35
443215-4321592.16292.47
544985-4498595.93796.26
645495-4549597.02597.35
20min145840-4584097.76095.372.1398.2595.852.13
244579-4457995.07195.55
344269-4426994.41094.88
443176-4317692.07992.54
544965-4496595.89496.37
645489-4548997.01297.50
30min145769-4576997.60995.252.4398.2695.882.43
244814-4481495.57296.21
344200-4420094.26394.89
442771-4277191.21591.83
544863-4486395.67796.32
645556-4555697.15597.80
45min145646-4564697.34794.882.2398.1695.682.23
244514-4451494.93395.73
343983-4398393.80094.59
442871-4287191.42992.19
544615-4461595.14895.95
645303-4530396.61597.43
极限145457-4545796.94494.602.3097.9295.552.30
244648-4464895.21896.17
343732-4373293.26594.21
442658-4265890.97491.89
544541-4454194.99095.95
645109-4510996.20297.17
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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.554840148251483684865448721484790.42
213.654892248987489540.10
单位质量响应值RSD%判断
3577.793586.370.17数据可信
供试品溶液-2024010321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%
5min154075-54075132.196128.532.41132.20128.532.41
253708-53708131.298131.30
352494-52494128.331128.33
450559-50559123.600123.60
552637-52637128.680128.68
651971-51971127.052127.05
10min154130-54130132.330132.011.16132.55132.221.16
254584-54584133.440133.66
354548-54548133.352133.57
454154-54154132.389132.59
552938-52938129.416129.63
653636-53636131.122131.33
15min152912-52912129.353131.052.04129.79131.482.04
254248-54248132.619133.06
355447-55447135.550135.99
453635-53635131.120131.55
552821-52821129.130129.56
652572-52572128.521128.95
20min153098-53098129.807131.231.02130.46131.881.02
253161-53161129.961130.62
354608-54608133.499134.16
453806-53806131.538132.18
553674-53674131.215131.86
653741-53741131.379132.02
30min153320-53320130.350130.451.04131.22131.321.03
252562-52562128.497129.38
353928-53928131.836132.72
454019-54019132.059132.92
553007-53007129.585130.45
653321-53321130.352131.22
45min153204-53204130.066129.160.74131.16130.250.74
252507-52507128.362129.46
353414-53414130.580131.68
452690-52690128.810129.89
552461-52461128.250129.33
652731-52731128.910129.99
极限153319-53319130.348128.951.33131.65130.251.31
251912-51912126.908128.21
351788-51788126.605127.93
453205-53205130.069131.37
553206-53206130.071131.37
653048-53048129.685130.98
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4000
标示量(mg)2.5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%
110.474347543402432394344943379433890.22
210.344382243656437390.27
单位质量响应值RSD%判断
4144.134230.081.46数据可信
供试品溶液-2024010321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%
5min144680-4468095.85696.232.4395.8696.232.43
246768-46768100.335100.34
345452-4545297.51297.51
443935-4393594.25894.26
544211-4421194.85094.85
644073-4407394.55494.55
10min145085-4508596.72597.382.6196.8897.542.61
247448-47448101.794101.96
346081-4608198.86199.02
444610-4461095.70695.86
544890-4489096.30696.46
644238-4423894.90895.07
15min144969-4496996.47697.172.6496.8097.502.64
247311-47311101.500101.84
346127-4612798.96099.29
444506-4450695.48395.80
544681-4468195.85896.18
644169-4416994.76095.08
20min144829-4482996.17596.942.3996.6697.422.39
247024-47024100.885101.39
345817-4581798.29598.79
444578-4457895.63796.11
544853-4485396.22796.71
643999-4399994.39594.87
30min144616-4461695.71996.592.5496.3697.232.54
246958-46958100.743101.42
345806-4580698.27298.93
444265-4426594.96595.60
544534-4453495.54396.18
643946-4394694.28194.91
45min144687-4468795.87196.432.5796.6797.242.57
246655-46655100.093100.94
346055-4605598.80699.63
444270-4427094.97695.77
544327-4432795.09895.90
643695-4369593.74394.53
极限144741-4474195.98796.362.4796.9597.322.47
246739-46739100.273101.28
345740-4574098.13099.11
444160-4416094.74095.69
544224-4422494.87895.83
643882-4388294.14495.09
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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.554866948555484154869548438485540.27
213.654869748227484620.69
单位质量响应值RSD%判断
3583.323550.330.66数据可信
供试品溶液-2024010321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%
5min152395-52395128.639131.352.60128.64131.352.60
255454-55454136.149136.15
352799-52799129.631129.63
454664-54664134.210134.21
553806-53806132.103132.10
651879-51879127.372127.37
10min154554-54554133.940135.331.90134.15135.551.91
256939-56939139.795140.02
354761-54761134.448134.66
455730-55730136.827137.05
554029-54029132.651132.87
654715-54715134.335134.55
15min153678-53678131.789133.421.33132.23133.871.32
254088-54088132.796133.26
354182-54182133.026133.47
455687-55687136.721137.17
553892-53892132.314132.76
654538-54538133.900134.34
20min154397-54397133.554133.772.41134.21134.432.41
256510-56510138.742139.42
352802-52802129.638130.30
455446-55446136.130136.81
553856-53856132.226132.89
653892-53892132.314132.97
30min154149-54149132.945133.651.55133.83134.541.55
255993-55993137.473138.39
354000-54000132.580133.46
454725-54725134.360135.27
554109-54109132.847133.73
653638-53638131.691132.57
45min154344-54344133.424132.272.83134.53133.382.82
255535-55535136.348137.49
353808-53808132.108133.21
454719-54719134.345135.48
553772-53772132.020133.12
651069-51069125.383126.48
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255862-55862137.151138.52
354086-54086132.791134.11
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653867-53867132.253133.56
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