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%
110.074279942672427804281142802427730.14
210.084273442692427130.07
单位质量响应值RSD%判断
4247.574237.400.17数据可信
加速3月-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%
5min144061-4406193.28494.381.9593.2894.381.95
245848-4584897.06897.07
344420-4442094.04494.04
445074-4507495.42995.43
543320-4332091.71591.72
644753-4475394.74994.75
10min144696-4469694.62995.461.9994.7895.612.00
246260-4626097.94098.10
344869-4486994.99595.15
445763-4576396.88897.05
543686-4368692.49092.64
645244-4524495.78995.95
15min144465-4446594.13994.831.9294.4595.151.91
246014-4601497.41997.74
344248-4424893.68094.00
445346-4534696.00596.33
543615-4361592.34092.65
645066-4506695.41295.73
20min144404-4440494.01094.992.0194.4895.462.01
246032-4603297.45797.94
344658-4465894.54895.02
445608-4560896.55997.04
543501-4350192.09992.56
644995-4499595.26295.74
30min144294-4429493.77794.781.9494.4095.411.94
245869-4586997.11297.76
344614-4461494.45595.08
445520-4552096.37397.01
543455-4345592.00192.62
644855-4485594.96595.60
45min144123-4412393.41594.642.0094.2095.431.99
245930-4593097.24198.05
344499-4449994.21195.00
445330-4533095.97196.77
543422-4342291.93192.70
644900-4490095.06095.85
极限144184-4418493.54594.641.9794.4895.581.97
245816-4581697.00097.97
344539-4453994.29695.24
445456-4545696.23897.20
543378-4337891.83892.76
644824-4482494.90095.85
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%
114.715428654275544115434554271543180.12
214.695410354170541360.09
单位质量响应值RSD%判断
3692.593685.230.15数据可信
加速3月-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%
5min156203-5620396.19595.261.1296.2095.261.12
256032-5603295.90295.90
354991-5499194.12194.12
455309-5530994.66594.66
555032-5503294.19194.19
656376-5637696.49196.49
10min156927-5692797.43496.591.0797.5996.751.07
256808-5680897.23197.39
355735-5573595.39495.55
456315-5631596.38796.54
555738-5573895.39995.56
657091-5709197.71597.88
15min155088-5508894.28793.501.1494.6193.821.14
255016-5501694.16394.49
354063-5406392.53292.85
454159-5415992.69793.02
554020-5402092.45992.77
655435-5543594.88195.20
20min154890-5489093.94893.500.8994.4393.980.89
255071-5507194.25894.74
354086-5408692.57293.04
454638-5463893.51693.99
553996-5399692.41892.89
655081-5508194.27594.76
30min154971-5497194.08693.571.1094.7294.201.10
255084-5508494.28094.92
354004-5400492.43193.06
454897-5489793.96094.59
553826-5382692.12792.75
655235-5523594.53895.18
45min154643-5464393.52593.671.0094.3294.461.00
255040-5504094.20495.00
354238-5423892.83293.61
454810-5481093.81194.60
554068-5406892.54193.32
655567-5556795.10695.90
极限154715-5471593.64893.850.9994.6094.800.99
254950-5495094.05095.00
354265-5426592.87893.81
455130-5513094.35995.30
554269-5426992.88593.82
655669-5566995.28196.24
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%
110.074280642803428304278542739427930.08
210.084234542344423440.01
单位质量响应值RSD%判断
4249.554200.790.82数据可信
长期3月-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%
5min144879-4487995.40895.431.4495.4195.431.44
244750-4475095.13495.13
344702-4470295.03295.03
444189-4418993.94193.94
546107-4610798.01998.02
644707-4470795.04395.04
10min145317-4531796.33996.371.4596.5096.531.45
245112-4511295.90496.06
345263-4526396.22596.38
444571-4457194.75494.91
546548-4654898.95699.12
645186-4518696.06196.22
15min145348-4534896.40596.251.3996.7296.571.39
245017-4501795.70296.02
345041-4504195.75396.07
444523-4452394.65194.97
546408-4640898.65998.99
645311-4531196.32796.65
20min145345-4534596.39996.131.4096.8896.611.39
244971-4497195.60496.08
344994-4499495.65396.13
444455-4445594.50794.98
546343-4634398.52199.01
645197-4519796.08496.56
30min145338-4533896.38496.311.3897.0396.951.38
245035-4503595.74096.38
345211-4521196.11496.75
444596-4459694.80795.44
546460-4646098.76999.43
645168-4516896.02396.66
45min145325-4532596.35696.101.4597.1696.901.45
245058-4505895.78996.59
344937-4493795.53296.33
444402-4440294.39495.18
546381-4638198.60199.42
645117-4511795.91496.71
极限145240-4524096.17695.951.5097.1496.911.50
245084-4508495.84496.80
344850-4485095.34796.30
444206-4420693.97894.92
546278-4627898.38299.37
645142-4514295.96796.93
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%
114.715413554254542895423354209542240.11
214.695401654016540160.00
单位质量响应值RSD%判断
3686.203677.060.18数据可信
长期3月-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%
5min156023-5602396.07796.581.3096.0896.581.30
257114-5711497.94897.95
355400-5540095.00895.01
456945-5694597.65897.66
556789-5678997.39097.39
655620-5562095.38595.39
10min154605-5460593.64594.871.3593.8095.041.35
255902-5590295.86996.03
355143-5514394.56794.73
456041-5604196.10796.27
555924-5592495.90796.07
654316-5431693.14993.31
15min154822-5482294.01794.821.3794.3395.141.37
255999-5599996.03596.36
354837-5483794.04394.36
455892-5589295.85296.17
555953-5595395.95796.28
654232-5423293.00593.32
20min155223-5522394.70594.511.0695.1894.991.06
256058-5605896.13796.62
354664-5466493.74694.22
454817-5481794.00894.49
555428-5542895.05695.54
654480-5448093.43093.90
30min155396-5539695.00195.261.0795.6395.901.07
255624-5562495.39296.04
355333-5533394.89395.52
456311-5631196.57097.21
556006-5600696.04796.69
654612-5461293.65794.28
45min155554-5555495.27295.341.5096.0696.131.50
256705-5670597.24698.05
355302-5530294.84095.63
455291-5529194.82195.62
556331-5633196.60597.41
654369-5436993.24094.02
极限155644-5564495.42795.981.5296.3796.931.51
256818-5681897.44098.40
355433-5543395.06596.01
456705-5670597.24698.20
556513-5651396.91797.88
654696-5469693.80194.74
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%
110.074256042605425834260942603425920.05
210.084258542558425720.05
单位质量响应值RSD%判断
4229.594223.410.11数据可信
中间条件3月-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%
5min143698-4369892.86595.041.6992.8795.041.69
245041-4504195.71995.72
344886-4488695.39095.39
443904-4390493.30393.30
545202-4520296.06296.06
645597-4559796.90196.90
10min143932-4393293.36395.421.5393.5295.581.53
245236-4523696.13496.29
344953-4495395.53295.69
444298-4429894.14094.30
545155-4515595.96296.12
645838-4583897.41397.57
15min144041-4404193.59495.551.5793.9095.871.57
245170-4517095.99496.31
344894-4489495.40795.73
444398-4439894.35394.67
545203-4520396.06496.38
646065-4606597.89698.22
20min144145-4414593.81595.221.3994.2895.701.39
245305-4530596.28096.76
344774-4477495.15295.63
444044-4404493.60194.07
544975-4497595.57996.06
645599-4559996.90597.39
30min143976-4397693.45695.101.5694.0895.741.56
245110-4511095.86696.51
344951-4495195.52896.16
443957-4395793.41694.04
544754-4475495.11095.75
645763-4576397.25497.90
45min144063-4406393.64194.861.3994.4295.661.39
244894-4489495.40796.21
344691-4469194.97695.77
443887-4388793.26794.05
544690-4469094.97495.77
645606-4560696.92097.73
极限143789-4378993.05994.841.5993.9995.791.59
245172-4517295.99896.96
344465-4446594.49595.45
443937-4393793.37394.31
544774-4477495.15296.11
645622-4562296.95497.93
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%
114.715423254333542615422854251542610.08
214.695426654196542310.10
单位质量响应值RSD%判断
3688.723691.700.06数据可信
中间条件3月-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%
5min155768-5576895.41794.682.3195.4294.682.31
253683-5368391.85091.85
355662-5566295.23695.24
453901-5390192.22392.22
556877-5687797.31497.31
656143-5614396.05896.06
10min156911-5691197.37395.621.9097.5395.781.89
254392-5439293.06393.22
356221-5622196.19296.35
454756-5475693.68593.84
556737-5673797.07597.24
656314-5631496.35196.51
15min156837-5683797.24695.802.4597.5796.122.45
254256-5425692.83093.14
356234-5623496.21496.53
454304-5430492.91293.22
557128-5712897.74498.07
657207-5720797.87998.20
20min157300-5730098.03896.693.4198.5297.173.40
254991-5499194.08794.55
356142-5614296.05796.54
454050-5405092.47792.94
557065-5706597.63698.12
659527-59527101.848102.33
30min157151-5715197.78395.822.5398.4396.462.53
254357-5435793.00393.62
356709-5670997.02797.67
454023-5402392.43193.05
556850-5685097.26897.92
656929-5692997.40398.06
45min156896-5689697.34795.032.2998.1695.832.29
254142-5414292.63593.41
355730-5573095.35296.15
453816-5381692.07792.85
556406-5640696.50897.32
656263-5626396.26497.08
极限156745-5674597.08897.054.0798.0698.014.02
260982-60982104.338105.27
355555-5555595.05296.01
454104-5410492.57093.50
556654-5665496.93397.91
656304-5630496.33497.31
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