培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354237642435424594178242274422650.67
210.294230142269422850.06
单位质量响应值RSD%判断
4083.574109.330.45数据可信
供试品溶液-2024052721批-培哚普利-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%
5min148686-48686102.548102.650.83102.55102.650.83
249508-49508104.279104.28
348460-48460102.072102.07
448599-48599102.364102.36
548740-48740102.661102.66
648410-48410101.966101.97
10min148528-48528102.215102.370.79103.35103.510.79
249251-49251103.738104.90
348359-48359101.859102.99
448192-48192101.507102.64
548829-48829102.849103.99
648446-48446102.042103.18
15min147623-47623100.309101.140.92102.58103.420.92
248815-48815102.819105.13
347754-47754100.585102.85
447932-47932100.960103.22
548222-48222101.570103.85
647770-47770100.618102.89
20min146986-4698698.96799.810.81102.36103.210.81
248073-48073101.256104.71
347289-4728999.605102.99
447295-4729599.618103.00
547543-47543100.140103.55
647139-4713999.289102.67
30min146481-4648197.90398.350.93102.39102.860.92
247365-4736599.765104.34
346590-4659098.133102.62
446444-4644497.825102.32
547068-4706899.140103.66
646221-4622197.356101.84
45min146533-4653398.01398.230.85103.59103.830.83
246844-4684498.668104.36
346211-4621197.335102.92
447053-4705399.108104.69
547011-4701199.020104.65
646151-4615197.208102.78
极限145807-4580796.48496.881.08103.15103.571.04
246112-4611297.126103.91
345635-4563596.121102.78
445828-4582896.528103.21
546943-4694398.876105.60
645646-4564696.144102.79
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.923876938692387263858438532386610.26
213.953851238406384590.20
单位质量响应值RSD%判断
2777.372756.920.53数据可信
供试品溶液-2024052721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%
5min143636-4363699.56699.310.9899.5799.310.98
243896-43896100.159100.16
343267-4326798.72498.72
444104-44104100.634100.63
543028-4302898.17898.18
643215-4321598.60598.61
10min144218-44218100.894100.970.70102.00102.070.70
244543-44543101.635102.75
343940-43940100.259101.36
444671-44671101.927103.05
543924-43924100.223101.31
644201-44201100.855101.95
15min143478-4347899.20599.751.11101.43101.971.10
244118-44118100.665102.91
343379-4337998.979101.19
444511-44511101.562103.81
543353-4335398.920101.12
643452-4345299.146101.36
20min142854-4285497.78198.651.14101.11101.991.13
243576-4357699.429102.79
343017-4301798.153101.46
444034-44034100.474103.85
542737-4273797.514100.82
643201-4320198.573101.89
30min142289-4228996.49296.861.00100.91101.300.99
242846-4284697.763102.23
342343-4234396.615101.02
443051-4305198.231102.73
542281-4228196.474100.86
641902-4190295.609100.02
45min142001-4200195.83596.451.50101.32101.961.47
242255-4225596.415101.97
341969-4196995.762101.24
443519-4351999.299104.89
542118-4211896.102101.56
641766-4176695.299100.77
极限141551-4155194.80895.180.98101.36101.760.96
241657-4165795.050101.67
341445-4144594.566101.11
442330-4233096.586103.28
542061-4206195.972102.50
641243-4124394.106100.64
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354238742360423724237642388423770.03
210.294206342285421740.38
单位质量响应值RSD%判断
4094.404098.540.08数据可信
供试品溶液-2024052721批-培哚普利-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%
5min147540-47540100.13297.224.25100.1397.224.25
246282-4628297.48397.48
342326-4232689.15089.15
446219-4621997.35097.35
547374-4737499.78399.78
647211-4721199.43999.44
10min147081-4708199.16697.721.62100.2898.801.61
245679-4567996.21397.30
346391-4639197.71298.70
445319-4531995.45496.54
547109-4710999.225100.33
646785-4678598.54299.65
15min146873-4687398.72896.601.76100.9498.761.77
245408-4540895.64297.79
345069-4506994.92897.00
445004-4500494.79196.93
546533-4653398.011100.22
646289-4628997.49799.70
20min145879-4587996.63495.121.6299.9598.361.61
243838-4383892.33595.55
345003-4500394.78997.92
445072-4507294.93498.13
545611-4561196.06999.37
645564-4556495.97099.25
30min142325-4232589.14891.923.0493.5396.222.90
242515-4251589.54893.79
344496-4449693.72197.91
443429-4342991.47495.72
545837-4583796.545100.91
643254-4325491.10595.45
45min144702-4470294.15592.791.4699.5398.111.45
242918-4291890.39795.63
343802-4380292.25997.48
444070-4407092.82498.09
544383-4438393.48398.92
644458-4445893.64199.00
极限144808-4480894.37892.542.04100.8098.892.00
243212-4321291.01697.26
343067-4306790.71196.96
443088-4308890.75597.05
544788-4478894.336100.82
644643-4464394.031100.43
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.923855538554385583859538506385540.09
213.953847938433384560.09
单位质量响应值RSD%判断
2769.682756.700.34数据可信
供试品溶液-2024052721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%
5min142414-4241496.91596.054.1996.9196.054.19
243242-4324298.80798.81
338513-3851388.00188.00
442905-4290598.03798.04
542860-4286097.93497.93
642285-4228596.62096.62
10min142341-4234196.74896.441.4697.8397.511.43
242785-4278597.76398.86
342884-4288497.98998.97
441770-4177095.44396.53
542203-4220396.43397.52
641267-4126794.29495.37
15min141368-4136894.52594.941.0296.6897.081.01
242270-4227096.58698.77
341464-4146494.74496.81
441144-4114494.01396.16
541805-4180595.52397.68
641247-4124794.24896.37
20min141366-4136694.52093.611.0297.7296.810.98
240618-4061892.81196.07
341160-4116094.05097.17
441424-4142494.65397.85
540845-4084593.33096.55
640401-4040192.31595.48
30min139510-3951090.27991.802.5794.5396.042.45
240015-4001591.43395.72
341344-4134494.47098.63
440320-4032092.13096.38
541227-4122794.20398.46
638642-3864288.29692.49
45min140058-4005891.53292.551.3396.7997.801.28
240156-4015691.75697.06
340754-4075493.12298.34
441363-4136394.51399.78
540711-4071193.02498.33
639974-3997491.34096.51
极限139998-3999891.39491.280.5497.6797.560.52
240072-4007291.56497.89
339905-3990591.18297.43
439590-3959090.46296.78
540224-4022491.91198.25
639899-3989991.16897.36
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354237342440423884241942329423900.11
210.294234942342423460.02
单位质量响应值RSD%判断
4095.654115.260.34数据可信
供试品溶液-2024052721批-培哚普利-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%
5min146175-4617597.04598.270.7897.0598.270.78
247073-4707398.93298.93
346823-4682398.40798.41
447111-4711199.01299.01
546879-4687998.52598.52
646479-4647997.68497.68
10min145870-4587096.40498.011.5097.4899.101.49
246648-4664898.03999.14
346772-4677298.30099.39
447095-4709598.979100.08
547607-47607100.055101.15
645822-4582296.30397.39
15min145256-4525695.11496.561.3297.2698.741.31
246288-4628897.28399.47
345591-4559195.81898.00
446606-4660697.951100.15
546541-4654197.814100.02
645385-4538595.38597.54
20min144528-4452893.58495.791.4696.7999.041.45
246089-4608996.864100.13
345561-4556195.75599.00
446177-4617797.049100.34
546047-4604796.776100.07
645058-4505894.69797.91
30min144785-4478594.12495.681.4298.37100.001.41
246028-4602896.736101.08
345306-4530695.21999.53
446244-4624497.190101.56
545980-4598096.635101.00
644821-4482194.19998.47
45min142424-4242489.16293.172.3294.4598.552.25
245009-4500994.594100.02
344391-4439193.29698.67
445076-4507694.735100.18
545042-4504294.664100.11
644035-4403592.54797.86
极限142268-4226888.83492.232.2595.1298.652.19
244210-4421092.91599.39
344327-4432793.16199.57
445093-4509394.771101.27
544172-4417292.83599.33
643248-4324890.89397.24
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.923849438515385253857638535385290.08
213.953840938406384080.01
单位质量响应值RSD%判断
2767.892753.260.38数据可信
供试品溶液-2024052721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%
5min143430-4343099.33199.261.2899.3399.261.28
242380-4238096.92996.93
343920-43920100.452100.45
443317-4331799.07299.07
543515-4351599.52599.53
643843-43843100.275100.28
10min143064-4306498.49498.741.9099.6099.841.89
241751-4175195.49196.57
343485-4348599.457100.57
443685-4368599.914101.01
544119-44119100.907102.01
642928-4292898.18399.30
15min142394-4239496.96196.961.3099.1699.161.30
241422-4142294.73896.88
342300-4230096.74698.97
442473-4247397.14299.35
543062-4306298.489100.72
642709-4270997.68299.89
20min141726-4172695.43496.041.1498.7199.321.14
241222-4122294.28197.47
342277-4227796.69499.99
441891-4189195.81199.10
542529-4252997.270100.59
642299-4229996.744100.03
30min141662-4166295.28795.991.0799.62100.341.08
241197-4119794.22498.46
342247-4224796.625101.00
442195-4219596.506100.86
542360-4236096.884101.29
642157-4215796.419100.78
45min139665-3966590.72093.471.7696.1198.881.71
240350-4035092.28697.57
341270-4127094.39199.83
441064-4106493.91999.35
541567-4156795.070100.55
641282-4128294.41899.85
极限139626-3962690.63192.491.7097.0398.941.66
239558-3955890.47596.79
341092-4109293.983100.48
441063-4106393.917100.39
540726-4072693.14699.68
640565-4056592.77899.26
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354239742401423984239042426424020.04
210.294246442479424720.03
单位质量响应值RSD%判断
4096.814127.500.53数据可信
供试品溶液-2024052721批-培哚普利-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%
5min147503-4750399.67499.701.4299.6799.701.43
247055-4705598.73498.73
348853-48853102.507102.51
447229-4722999.09999.10
547120-4712098.87198.87
647327-4732799.30599.30
10min147155-4715598.94499.161.33100.05100.271.32
246960-4696098.53599.63
348252-48252101.246102.38
446482-4648297.53298.63
547705-47705100.098101.20
647006-4700698.63199.73
15min147241-4724199.12498.421.48101.33100.621.47
246548-4654897.67099.86
347739-47739100.169102.43
445863-4586396.23398.42
547428-4742899.517101.73
646599-4659997.77799.98
20min146716-4671698.02395.442.72101.3398.742.67
244413-4441393.19196.47
346972-4697298.560101.94
443837-4383791.98295.24
545637-4563795.75999.08
645328-4532895.11098.40
30min145541-4554195.55795.091.0699.9599.451.06
245576-4557695.63199.94
346015-4601596.552101.02
444886-4488694.18398.46
544735-4473593.86698.25
645162-4516294.76299.10
45min144317-4431792.98993.461.8598.4598.881.82
243835-4383591.97897.35
345975-4597596.468102.01
443757-4375791.81497.14
544435-4443593.23798.66
644937-4493794.29099.69
极限144625-4462593.63593.481.26100.1399.931.26
244121-4412192.57898.97
345135-4513594.705101.32
443651-4365191.59297.93
544925-4492594.265100.72
644838-4483894.082100.53
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.923855638515385693859638574385620.08
213.953858838572385800.03
单位质量响应值RSD%判断
2770.262765.590.12数据可信
供试品溶液-2024052721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%
5min142006-4200695.81898.391.9595.8298.391.95
242983-4298398.04798.05
344549-44549101.619101.62
443290-4329098.74798.75
543249-4324998.65498.65
642722-4272297.45197.45
10min142014-4201495.83698.261.8796.9099.351.86
243120-4312098.35999.45
344225-44225100.880102.01
442646-4264697.27898.38
543742-4374299.778100.87
642713-4271397.43198.51
15min142608-4260897.19197.451.4399.3299.641.43
242540-4254097.03699.22
343707-4370799.698101.95
441956-4195695.70497.88
543110-4311098.336100.54
642412-4241296.74498.91
20min141569-4156994.82194.572.9998.0397.842.93
240500-4050092.38395.64
343523-4352399.279102.64
440003-4000391.24994.49
541980-4198095.75999.06
641180-4118093.93497.17
30min140308-4030891.94593.931.9696.2198.241.93
241980-4198095.759100.05
342321-4232196.537101.00
440953-4095393.41697.67
540991-4099193.50397.86
640507-4050792.39996.68
45min139642-3964290.42692.511.8995.7197.881.86
240038-4003891.32996.68
341721-4172195.168100.70
440135-4013591.55096.84
540764-4076492.98598.39
641043-4104393.62298.93
极限139487-3948790.07292.351.8796.3698.741.84
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