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%
110.078443084815849068479785046847990.27
210.088533585225852800.10
单位质量响应值RSD%判断
8420.958460.320.33数据可信
中间条件3月-供试品溶液-2023101321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%
5min192095-9209598.00298.631.8198.0098.631.81
291446-9144697.31297.31
391203-9120397.05397.05
495019-95019101.114101.11
591763-9176397.64997.65
694606-94606100.674100.67
10min192821-9282198.77599.241.4698.9499.401.46
291990-9199097.89198.05
391949-9194997.84798.01
494879-94879100.965101.13
592928-9292898.88999.05
694967-94967101.059101.23
15min192403-9240398.33099.061.4698.6699.391.47
291965-9196597.86498.19
391811-9181197.70098.02
494713-94713100.788101.13
592760-9276098.71099.04
694856-94856100.940101.28
20min192587-9258798.52699.061.2999.0299.561.30
291834-9183497.72598.21
392365-9236598.29098.78
494575-94575100.641101.15
592569-9256998.50799.00
694624-94624100.694101.20
30min192349-9234998.27398.681.3298.9399.341.32
291607-9160797.48398.13
391562-9156297.43598.09
494179-94179100.220100.89
592387-9238798.31398.97
694288-94288100.336101.01
45min192012-9201297.91498.481.4998.7399.301.48
291459-9145997.32698.14
391281-9128197.13697.95
494141-94141100.180101.02
591960-9196097.85998.68
694399-94399100.454101.29
极限191732-9173297.61698.201.4098.6099.191.40
291048-9104896.88897.86
391192-9119297.04198.02
493889-9388999.911100.92
591957-9195797.85598.84
693886-9388699.908100.92
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%
114.715416954554544505437354382543860.26
214.695468554563546240.16
单位质量响应值RSD%判断
3697.213718.450.41数据可信
中间条件3月-供试品溶液-2023101321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%
5min155882-5588295.15895.731.1995.1695.731.19
255398-5539894.33494.33
356454-5645496.13296.13
456377-5637796.00196.00
555870-5587095.13895.14
657324-5732497.61497.61
10min156208-5620895.71396.160.8595.8796.320.85
256484-5648496.18396.34
356608-5660896.39496.55
456855-5685596.81596.98
555672-5567294.80194.96
656986-5698697.03897.20
15min155915-5591595.21496.040.7495.5396.360.74
256367-5636795.98496.30
356744-5674496.62696.95
456829-5682996.77197.09
555889-5588995.17095.49
656651-5665196.46896.79
20min155689-5568994.83095.500.9395.3195.980.93
255577-5557794.63995.12
356200-5620095.70096.18
456709-5670996.56697.05
555657-5565794.77595.25
656670-5667096.50096.99
30min154505-5450592.81394.781.4393.4595.421.42
255561-5556194.61295.25
355271-5527194.11894.76
456538-5653896.27596.92
555519-5551994.54095.17
656581-5658196.34896.99
45min155340-5534094.23595.111.2795.0295.911.27
255563-5556394.61595.41
355350-5535094.25295.05
456423-5642396.07996.88
555426-5542694.38295.17
657034-5703497.12097.93
极限155199-5519993.99595.011.2194.9495.971.20
255379-5537994.30295.25
355455-5545594.43195.39
456621-5662196.41797.38
555438-5543894.40295.35
656686-5668696.52797.50
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%
110.078480484815850008501184867848990.12
210.088531185306853080.01
单位质量响应值RSD%判断
8430.888463.100.27数据可信
中间条件3月-供试品溶液-2023101323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%
5min192793-9279398.67198.091.0298.6798.091.02
291450-9145097.24397.24
392964-9296498.85298.85
492925-9292598.81198.81
592636-9263698.50498.50
690710-9071096.45696.46
10min193690-9369099.62498.870.8999.7999.040.89
292385-9238598.23798.40
393504-9350499.42799.59
493847-9384799.79199.96
592679-9267998.54998.71
691806-9180697.62197.78
15min193626-9362699.55698.830.9899.8999.160.98
292507-9250798.36798.69
393866-9386699.812100.14
493654-9365499.58699.92
592402-9240298.25598.58
691615-9161597.41897.74
20min193437-9343799.35598.740.9199.8599.230.91
292654-9265498.52399.01
393719-9371999.655100.15
493417-9341799.33499.83
592462-9246298.31998.81
691461-9146197.25497.74
30min193282-9328299.19198.471.2699.8599.131.26
291861-9186197.68098.33
393501-9350199.423100.09
493873-9387399.819100.48
592316-9231698.16398.82
690809-9080996.56197.21
45min193016-9301698.90898.241.0699.7499.061.06
291967-9196797.79298.61
393085-9308598.98199.81
493521-9352199.445100.27
591824-9182497.64098.46
690930-9093096.69097.50
极限189866-8986695.55897.161.2996.5598.141.28
291674-9167497.48198.46
392819-9281998.69899.69
492375-9237598.22699.22
591303-9130397.08698.07
690190-9019095.90396.87
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.715408254847546445437154446544780.53
214.695477554647547110.17
单位质量响应值RSD%判断
3703.473724.370.40数据可信
中间条件3月-供试品溶液-2023101323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%
5min154610-5461092.84091.301.9292.8491.301.92
254983-5498393.47493.47
354182-5418292.11292.11
452504-5250489.25989.26
553244-5324490.51790.52
652716-5271689.62089.62
10min152474-5247489.20891.052.6589.3691.202.65
254266-5426692.25592.41
355422-5542294.22094.37
451402-5140287.38687.53
553811-5381191.48191.63
653976-5397691.76291.91
15min155593-5559394.51192.542.5694.8192.842.56
255718-5571894.72395.03
355766-5576694.80595.12
453252-5325290.53190.83
553412-5341290.80391.11
652855-5285589.85690.16
20min155197-5519793.83893.172.2794.3093.632.27
256458-5645895.98196.45
355789-5578994.84495.31
453428-5342890.83091.28
553421-5342190.81891.27
654550-5455092.73893.19
30min154123-5412392.01291.222.2092.6391.832.20
254836-5483693.22493.85
354916-5491693.36093.99
452261-5226188.84689.44
552324-5232488.95389.56
653468-5346890.89891.50
45min154291-5429192.29791.142.6893.0791.902.67
255388-5538894.16294.95
354573-5457392.77793.56
451554-5155487.64488.39
552404-5240489.08989.84
653437-5343790.84691.60
极限151657-5165787.81990.652.4588.7491.572.44
254120-5412092.00792.95
355129-5512993.72294.66
452386-5238689.05989.95
552644-5264489.49790.40
654010-5401091.82092.73
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%
110.078496184975849228485685094849620.11
210.088485284831848420.02
单位质量响应值RSD%判断
8437.148416.870.18数据可信
中间条件3月-供试品溶液-2024010421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%
5min192210-9221098.28396.821.8498.2896.821.84
290510-9051096.47196.47
388395-8839594.21794.22
492703-9270398.80998.81
591692-9169297.73197.73
689527-8952795.42395.42
10min192765-9276598.87597.581.7999.0497.741.79
290118-9011896.05396.21
390161-9016196.09996.26
493001-9300199.12699.29
593338-9333899.48599.65
689932-8993295.85596.01
15min192885-9288599.00297.571.7799.3397.901.77
289927-8992795.85096.17
389840-8984095.75796.07
493550-9355099.711100.04
592434-9243498.52298.85
690620-9062096.58896.91
20min192332-9233298.41397.181.6298.9197.671.62
290047-9004795.97896.46
389995-8999595.92296.40
492848-9284898.96399.46
592305-9230598.38498.88
689515-8951595.41195.89
30min192114-9211498.18196.951.4698.8497.601.46
290050-9005095.98196.62
389439-8943995.33095.97
492540-9254098.63599.30
591734-9173497.77698.43
689871-8987195.79096.43
45min192048-9204898.11096.841.7498.9397.661.74
289730-8973095.64096.44
389548-8954895.44696.24
491936-9193697.99198.82
592797-9279798.90999.73
689099-8909994.96795.77
极限192508-9250898.60196.781.9899.5997.751.98
289237-8923795.11496.07
388551-8855194.38395.34
492485-9248598.57699.56
592174-9217498.24599.23
689844-8984495.76196.72
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%
114.715443254353543775420354562543850.24
214.695441754336543760.11
单位质量响应值RSD%判断
3697.143701.570.09数据可信
中间条件3月-供试品溶液-2024010421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%
5min156777-5677796.90393.142.2096.9093.142.20
254938-5493893.76493.76
353578-5357891.44391.44
454399-5439992.84492.84
554182-5418292.47492.47
653553-5355391.40091.40
10min156944-5694497.18894.071.8297.3594.221.82
254990-5499093.85394.01
354766-5476693.47193.62
454527-5452793.06393.22
555397-5539794.54894.70
654074-5407492.29092.44
15min157282-5728297.76594.281.8998.0994.591.89
254878-5487893.66293.97
354874-5487493.65593.96
455259-5525994.31294.62
554768-5476893.47493.79
654380-5438092.81293.12
20min156959-5695997.21494.741.7597.7095.211.75
255291-5529194.36794.84
355087-5508794.01994.48
454262-5426292.61193.08
555137-5513794.10494.57
656338-5633896.15496.61
30min157159-5715997.55594.391.8098.2095.011.80
255529-5552994.77395.40
354831-5483193.58294.20
454486-5448692.99393.61
555239-5523994.27894.90
654570-5457093.13693.76
45min156399-5639996.25893.561.9297.0794.341.92
254666-5466693.30094.08
354504-5450493.02493.80
453971-5397192.11492.89
555716-5571695.09295.87
653651-5365191.56892.34
极限157076-5707697.41393.622.1398.3894.562.12
254607-5460793.19994.14
353929-5392992.04292.97
454681-5468193.32694.26
554911-5491193.71894.66
653910-5391092.01092.94
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