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%
110.318756287615875868743887407875220.11
210.408718388099876410.74
单位质量响应值RSD%判断
8489.048427.020.52数据可信
加速6月-供试品溶液-2024010421批-比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193781-9378199.59296.122.4399.5996.122.43
287270-8727092.67892.68
391681-9168197.36297.36
489454-8945494.99795.00
590024-9002495.60295.60
690867-9086796.49796.50
10min194747-94747100.61897.052.35100.7897.202.35
288242-8824293.71093.86
392207-9220797.92098.08
490565-9056596.17796.34
590872-9087296.50396.66
691668-9166897.34897.51
15min194447-94447100.29997.382.64100.6397.702.64
288022-8802293.47693.79
391879-9187997.57297.90
490327-9032795.92496.24
594175-94175100.010100.33
691343-9134397.00397.33
20min194217-94217100.05596.462.37100.5696.942.38
287617-8761793.04693.51
391663-9166397.34397.83
490049-9004995.62996.11
590570-9057096.18296.67
690861-9086196.49196.98
30min193688-9368899.49395.982.30100.1696.622.30
287339-8733992.75193.37
391162-9116296.81197.46
489661-8966195.21795.85
590046-9004695.62696.27
690394-9039495.99596.64
45min193413-9341399.20195.522.46100.0396.322.46
286654-8665492.02392.80
390828-9082896.45697.27
489136-8913694.65995.46
589703-8970395.26196.07
689941-8994195.51496.32
极限192913-9291398.67095.122.3799.6796.092.37
286454-8645491.81192.74
390364-9036495.96396.94
488741-8874194.24095.19
589211-8921194.73995.70
689761-8976195.32396.29
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%
113.774892048958489604888149076489590.15
213.784930149301493010.00
单位质量响应值RSD%判断
3555.483577.720.45数据可信
加速6月-供试品溶液-2024010421批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154601-5460196.65994.721.7996.6694.721.79
253568-5356894.83094.83
352819-5281993.50493.50
454690-5469096.81696.82
552441-5244192.83592.83
652905-5290593.65693.66
10min154866-5486697.12895.632.0597.2995.792.05
254810-5481097.02997.19
353299-5329994.35494.51
455342-5534297.97098.13
552809-5280993.48693.64
653006-5300693.83593.99
15min154529-5452996.53195.691.4196.8596.011.41
254194-5419495.93896.26
353396-5339694.52594.84
455255-5525597.81698.14
553710-5371095.08195.39
653253-5325394.27294.58
20min154139-5413995.84195.131.4796.3295.601.47
253945-5394595.49795.98
353706-5370695.07495.54
454874-5487497.14297.63
552633-5263393.17593.64
653121-5312194.03994.51
30min154343-5434396.20294.831.6296.8595.471.62
254167-5416795.89096.53
352781-5278193.43794.07
454497-5449796.47597.12
552533-5253392.99893.62
653093-5309393.98994.62
45min153666-5366695.00394.141.7695.8194.931.76
253239-5323994.24895.05
352361-5236192.69393.48
454753-5475396.92897.74
552743-5274393.36994.15
652296-5229692.57893.36
极限153480-5348094.67493.532.1095.6494.482.10
252796-5279693.46394.42
352409-5240992.77893.72
454627-5462796.70597.68
552265-5226592.52393.46
651418-5141891.02491.96
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%
110.318818888178881378809288053881300.07
210.408776287969878660.17
单位质量响应值RSD%判断
8548.018448.650.83数据可信
长期6月-供试品溶液-2024010421批-比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190352-9035295.49795.281.7795.5095.281.77
287734-8773492.73092.73
390283-9028395.42595.42
490600-9060095.76095.76
592576-9257697.84897.85
689355-8935594.44494.44
10min191530-9153096.74396.221.8296.9096.381.82
288585-8858593.63093.78
390807-9080795.97896.14
491481-9148196.69196.85
593588-9358898.91899.08
690238-9023895.37795.53
15min191062-9106296.24895.941.7896.5796.261.78
288281-8828193.30993.62
390748-9074895.91696.24
491303-9130396.50396.82
593198-9319898.50698.83
690026-9002695.15395.47
20min190708-9070895.87495.671.7896.3596.151.78
288084-8808493.10093.57
390591-9059195.75096.23
491036-9103696.22096.70
592982-9298298.27798.77
689701-8970194.80995.28
30min190499-9049995.65395.351.6696.2995.991.66
287921-8792192.92893.55
390454-9045495.60596.24
490613-9061395.77396.42
592414-9241497.67798.33
689370-8937094.46095.09
45min190056-9005695.18595.021.6895.9895.811.68
287750-8775092.74793.52
389839-8983994.95595.75
490525-9052595.68096.48
592241-9224197.49498.31
688982-8898294.04994.84
极限189667-8966794.77394.561.7895.7395.521.78
287265-8726592.23593.17
389440-8944094.53495.49
489914-8991495.03596.00
592026-9202697.26798.25
688493-8849393.53394.48
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%
113.774923549316495924953948784492930.66
213.784967849383495300.43
单位质量响应值RSD%判断
3579.743594.340.29数据可信
长期6月-供试品溶液-2024010421批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152898-5289893.11093.142.6793.1193.142.67
250187-5018788.33888.34
353291-5329193.80293.80
454240-5424095.47295.47
553620-5362094.38194.38
653239-5323993.71093.71
10min153690-5369094.50495.811.4394.6695.961.43
253521-5352194.20694.35
354561-5456196.03796.19
455158-5515897.08897.25
555452-5545297.60597.76
654205-5420595.41095.57
15min152625-5262592.62994.911.9792.9495.221.97
252994-5299493.27993.58
353757-5375794.62294.94
454637-5463796.17196.49
555517-5551797.72098.04
653991-5399195.03495.35
20min152012-5201291.55094.032.0992.0294.502.09
252413-5241392.25692.72
353031-5303193.34493.82
454324-5432495.62096.10
554845-5484596.53797.02
653890-5389094.85695.33
30min151874-5187491.30792.651.8691.9393.281.86
251069-5106989.89090.50
353190-5319093.62494.25
453577-5357794.30594.95
553373-5337393.94694.59
652737-5273792.82693.46
45min151028-5102889.81892.542.1590.5993.332.15
251896-5189691.34692.11
352188-5218891.86092.65
453810-5381094.71595.51
553936-5393694.93795.74
652601-5260192.58793.37
极限150861-5086189.52490.672.4890.4591.612.47
250209-5020988.37789.29
353522-5352294.20895.15
450878-5087889.55490.51
552641-5264192.65793.62
650963-5096389.70490.64
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%
110.318806688125882438823888235881810.10
210.408795387848879000.09
单位质量响应值RSD%判断
8552.968451.920.85数据可信
中间条件6月-供试品溶液-2024010421批-比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193578-9357898.86098.022.1798.8698.022.17
290286-9028695.38295.38
395375-95375100.758100.76
491500-9150096.66496.66
594542-9454299.87899.88
691439-9143996.60096.60
10min194088-9408899.39898.822.1399.5698.992.13
291171-9117196.31796.48
396031-96031101.451101.62
492840-9284098.08098.24
595453-95453100.840101.01
691688-9168896.86397.02
15min193918-9391899.21998.622.1099.5598.952.10
291371-9137196.52896.85
395730-95730101.133101.47
492428-9242897.64597.97
595370-95370100.753101.09
691294-9129496.44796.77
20min193789-9378999.08298.312.1299.5898.802.12
291046-9104696.18596.67
395540-95540100.932101.44
492355-9235597.56898.05
594824-94824100.176100.68
690805-9080595.93096.41
30min193465-9346598.74098.062.1199.4098.712.11
290729-9072995.85096.49
395134-95134100.503101.18
492208-9220897.41298.06
594746-94746100.093100.76
690628-9062895.74396.39
45min193311-9331198.57797.672.1699.4098.502.16
290086-9008695.17095.97
394749-94749100.097100.94
491669-9166996.84397.66
594405-9440599.733100.57
690517-9051795.62696.43
极限192887-9288798.13097.102.0599.1298.092.05
289398-8939894.44495.40
394321-9432199.644100.65
490974-9097496.10997.08
593326-9332698.59399.60
690594-9059495.70796.67
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%
113.774921349712495454930649389494330.41
213.784960749446495260.23
单位质量响应值RSD%判断
3589.913594.050.09数据可信
中间条件6月-供试品溶液-2024010421批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153891-5389194.72794.232.3194.7394.232.31
251956-5195691.32691.33
354602-5460295.97795.98
453332-5333293.74493.74
555261-5526197.13597.14
652604-5260492.46592.46
10min155693-5569397.89495.803.7598.0595.963.74
252734-5273492.69392.85
356555-5655599.41099.57
452391-5239192.09092.25
556748-5674899.74999.91
652898-5289892.98193.14
15min154438-5443895.68896.112.3996.0196.432.39
253200-5320093.51293.82
356034-5603498.49498.82
454136-5413695.15895.47
556496-5649699.30699.63
653770-5377094.51494.82
20min154841-5484196.39795.631.8096.8896.111.80
253134-5313493.39693.86
355738-5573897.97398.46
453889-5388994.72395.19
555095-5509596.84397.34
653746-5374694.47294.94
30min154654-5465496.06894.771.5496.7195.411.54
252557-5255792.38293.00
354605-5460595.98296.64
453667-5366794.33394.96
554495-5449595.78996.44
653528-5352894.08994.71
45min154386-5438695.59794.571.9996.4095.361.98
251962-5196291.33692.11
354139-5413995.16395.98
453149-5314993.42394.21
554899-5489996.49997.31
654276-5427695.40496.18
极限153526-5352694.08594.122.3095.0595.072.29
251754-5175490.97191.90
355275-5527597.16098.13
453205-5320593.52194.46
554512-5451295.81896.79
652999-5299993.15994.10
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%
110.318805788047883218815188333881820.16
210.408806287923879920.12
单位质量响应值RSD%判断
8553.068460.770.77数据可信
加速6月-供试品溶液-2024010421批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191651-9165196.77296.941.5096.7796.941.50
292267-9226797.42397.42
391683-9168396.80696.81
491847-9184796.97996.98
593829-9382999.07299.07
689557-8955794.56194.56
10min191868-9186897.00197.781.6697.1697.941.66
293372-9337298.58998.75
392094-9209497.24097.40
493085-9308598.28698.45
594854-94854100.154100.32
690354-9035495.40395.56
15min192132-9213297.28097.941.7797.6098.261.77
292817-9281798.00398.33
392763-9276397.94698.27
493187-9318798.39498.72
595352-95352100.680101.01
690281-9028195.32695.64
20min191869-9186997.00297.561.7797.4998.051.77
292765-9276597.94998.44
392521-9252197.69198.18
492851-9285198.03998.53
594696-9469699.987100.49
689674-8967494.68595.16
30min191630-9163096.75097.481.7297.4098.121.72
292972-9297298.16798.82
392221-9222197.37498.02
492545-9254597.71698.37
594666-9466699.956100.62
689868-8986894.89095.52
45min191387-9138796.49497.231.9597.3098.051.95
292115-9211597.26298.08
391956-9195697.09497.91
492716-9271697.89798.71
594928-94928100.232101.07
689422-8942294.41995.21
极限191267-9126796.36797.011.8697.3497.991.86
292134-9213497.28298.26
391381-9138196.48797.46
492107-9210797.25498.23
594804-94804100.101101.10
689584-8958494.59095.54
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%
113.774961949310495134941448943493600.53
213.784956149571495660.02
单位质量响应值RSD%判断
3584.603596.950.25数据可信
加速6月-供试品溶液-2024010421批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152767-5276792.78295.551.7692.7895.551.76
254064-5406495.06395.06
354581-5458195.97295.97
454736-5473696.24596.24
555678-5567897.90197.90
654235-5423595.36495.36
10min154159-5415995.23097.662.7495.3897.822.74
256109-5610998.65998.82
357952-57952101.899102.06
454799-5479996.35596.52
556255-5625598.91699.08
653984-5398494.92295.08
15min155809-5580998.13199.312.0398.4499.642.03
255019-5501996.74297.07
358419-58419102.721103.05
456367-5636799.11299.43
556902-56902100.053100.38
656377-5637799.13099.45
20min155459-5545997.51698.382.3197.9998.862.30
255473-5547397.54098.02
358123-58123102.200102.70
455186-5518697.03697.52
556824-5682499.916100.41
654623-5462396.04696.53
30min155330-5533097.28997.922.7197.9398.582.70
256039-5603998.53699.18
357796-57796101.625102.30
453149-5314993.45494.10
556137-5613798.70899.37
655699-5569997.93898.58
45min154489-5448995.81098.132.3996.6198.942.39
256256-5625698.91799.73
357658-57658101.382102.22
454303-5430395.48396.29
556817-5681799.904100.73
655325-5532597.28098.09
极限153686-5368694.39897.712.0995.3698.692.08
254779-5477996.32097.30
356662-5666299.631100.64
455846-5584698.19699.16
556677-5667799.658100.65
655762-5576298.04999.02
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%
110.318864488554886588863687847884680.40
210.408818288175881780.01
单位质量响应值RSD%判断
8580.808478.650.85数据可信
长期6月-供试品溶液-2024010421批-比索洛尔-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191130-9113095.96594.981.4195.9794.981.41
291898-9189896.77496.77
390362-9036295.15795.16
490204-9020494.99094.99
588403-8840393.09493.09
689171-8917193.90393.90
10min192285-9228597.18296.101.7097.3496.251.70
293672-9367298.64298.80
391434-9143496.28696.44
490475-9047595.27695.43
589423-8942394.16894.32
690240-9024095.02895.18
15min191324-9132496.17095.961.5396.4996.281.53
293424-9342498.38198.71
391731-9173196.59896.92
490801-9080195.61995.94
589720-8972094.48194.79
689770-8977094.53394.85
20min191683-9168396.54895.811.7597.0396.291.75
293174-9317498.11898.61
391771-9177196.64097.12
490963-9096395.79096.27
589123-8912393.85294.32
689198-8919893.93194.40
30min191454-9145496.30795.631.6996.9596.281.69
293142-9314298.08498.74
391484-9148496.33896.98
490442-9044295.24195.88
589035-8903593.75994.39
689339-8933994.07994.71
45min191485-9148596.33995.661.6597.1496.461.65
293089-9308998.02898.85
391226-9122696.06796.87
490786-9078695.60396.40
588820-8882093.53394.32
689618-8961894.37395.16
极限191005-9100595.83495.491.3596.8096.441.35
292756-9275697.67898.66
390908-9090895.73296.69
490334-9033495.12796.08
589200-8920093.93394.87
689862-8986294.63095.57
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%
113.774993649150494944977049612495920.61
213.784939849914496560.74
单位质量响应值RSD%判断
3601.453603.480.04数据可信
长期6月-供试品溶液-2024010421批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156040-5604098.21795.911.6698.2295.911.66
253970-5397094.59094.59
354462-5446295.45295.45
454182-5418294.96194.96
554014-5401494.66794.67
655681-5568197.58897.59
10min156576-5657699.15797.791.2799.3297.951.27
255709-5570997.63797.79
355292-5529296.90697.07
454722-5472295.90796.07
556038-5603898.21498.37
656427-5642798.89699.06
15min157049-5704999.98698.291.13100.3198.621.13
256168-5616898.44298.76
355182-5518296.71497.03
455641-5564197.51897.84
556160-5616098.42898.75
656297-5629798.66899.00
20min156881-5688199.69197.421.49100.1997.911.49
255687-5568797.59998.08
354356-5435695.26695.75
455309-5530996.93697.42
555395-5539597.08797.57
655888-5588897.95198.44
30min156573-5657399.15297.261.4599.8197.901.44
254604-5460495.70196.35
355099-5509996.56897.21
454920-5492096.25596.90
555387-5538797.07397.72
656362-5636298.78299.44
45min156216-5621698.52697.251.1899.3598.071.18
255484-5548497.24398.05
354779-5477996.00796.81
454768-5476895.98896.79
555447-5544797.17897.99
656250-5625098.58699.41
极限156921-5692199.76297.441.50100.7598.411.50
254732-5473295.92596.89
355106-5510696.58097.54
455057-5505796.49597.46
555496-5549697.26498.24
656253-5625398.59199.57
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