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%
19.734066140767409044064340615407180.30
29.694115141046410980.19
单位质量响应值RSD%判断
4184.794241.280.95数据可信
影响因素30天-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%
5min148692-4869299.72699.911.4899.7399.911.48
248304-4830498.93198.93
349793-49793101.981101.98
449468-49468101.315101.32
548555-4855599.44599.45
647878-4787898.05998.06
10min148091-4809198.49599.440.7899.60100.550.78
248788-4878899.922101.02
348593-4859399.523100.66
449098-49098100.557101.68
548579-4857999.494100.60
648169-4816998.65599.74
15min146947-4694796.15298.741.9098.35100.961.88
247861-4786198.024100.23
349489-49489101.358103.60
449055-49055100.469102.71
547927-4792798.159100.37
647989-4798998.286100.47
20min146818-4681895.88896.911.3099.16100.221.30
247009-4700996.27999.58
347849-4784997.999101.36
448307-4830798.937102.30
547035-4703596.33299.63
646875-4687596.00499.28
30min146497-4649795.23096.081.1299.57100.471.11
246790-4679095.830100.20
347513-4751397.311101.77
447054-4705496.371100.83
547436-4743697.153101.52
646192-4619294.60698.95
45min145602-4560293.39794.710.8398.79100.160.81
246276-4627694.778100.21
346285-4628594.796100.33
446254-4625494.733100.26
546801-4680195.853101.30
646233-4623394.689100.09
极限145112-4511292.39493.711.1298.83100.221.10
245625-4562593.44499.93
346457-4645795.148101.74
445854-4585493.913100.50
546159-4615994.538101.05
645308-4530892.79599.24
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%
113.513739936799369903683736873369800.67
213.473701437232371230.42
单位质量响应值RSD%判断
2737.232755.980.49数据可信
影响因素30天-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%
5min141511-4151195.42597.432.9795.4397.432.97
243360-4336099.67699.68
344014-44014101.179101.18
443035-4303598.92998.93
541520-4152095.44695.45
640857-4085793.92293.92
10min141131-4113194.55297.592.4995.6198.672.49
243935-43935100.997102.10
343154-4315499.202100.33
442887-4288798.58899.69
541984-4198496.51297.57
641614-4161495.66296.71
15min140303-4030392.64896.593.2494.7698.763.22
242746-4274698.264100.49
343952-43952101.036103.26
442763-4276398.303100.50
541287-4128794.91097.04
641058-4105894.38496.49
20min140788-4078893.76394.582.0396.9097.822.04
241568-4156895.55698.88
342140-4214096.871100.22
441775-4177596.03299.32
540695-4069593.54996.74
639895-3989591.71094.87
30min140285-4028592.60794.312.1596.7998.602.16
241953-4195396.441100.82
342242-4224297.106101.53
440852-4085293.91098.26
540713-4071393.59197.82
640098-4009892.17796.35
45min138794-3879489.17991.832.7794.3997.172.74
241258-4125894.844100.30
341295-4129594.929100.43
439577-3957790.97996.38
539867-3986791.64696.91
638899-3889989.42194.62
极限138327-3832788.10691.493.1794.3197.853.12
241257-4125794.841101.35
341321-4132194.988101.55
439864-3986491.63998.05
539219-3921990.15696.44
638813-3881389.22395.41
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%
19.734100040768407534087940472407740.49
29.694065440649406520.01
单位质量响应值RSD%判断
4190.544195.250.08数据可信
影响因素30天-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%
5min147249-4724997.23198.571.0597.2398.571.05
248227-4822799.24399.24
348422-4842299.64599.64
447387-4738797.51597.51
548321-4832199.43799.44
647800-4780098.36598.36
10min147074-4707496.87198.151.4197.9599.251.41
248199-4819999.186100.29
348677-48677100.169101.28
446904-4690496.52197.60
547732-4773298.22599.33
647593-4759397.93999.03
15min146305-4630595.28896.740.9997.4498.920.99
247357-4735797.45399.66
347477-4747797.70099.92
446603-4660395.90198.06
547258-4725897.24999.45
647054-4705496.82999.01
20min145442-4544293.51295.241.2096.7398.501.19
246634-4663495.96599.25
346804-4680496.31599.62
446135-4613594.93898.16
546778-4677896.26299.54
645882-4588294.41897.67
30min143564-4356489.64893.772.4593.9098.082.38
246670-4667096.039100.39
345865-4586594.38398.76
445252-4525293.12197.40
546453-4645395.59399.94
645590-4559093.81798.12
45min144982-4498292.56693.711.4997.8299.071.47
245635-4563593.90999.33
346238-4623895.150100.57
444907-4490792.41197.72
546445-4644595.576100.98
645027-4502792.65898.01
极限144173-4417390.90193.081.2897.1899.481.28
245383-4538393.39199.86
345788-4578894.224100.71
445082-4508292.77199.11
545660-4566093.961100.43
645307-4530793.23499.61
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%
113.513650436522369143667236864366950.52
213.473712037146371330.05
单位质量响应值RSD%判断
2716.142756.721.05数据可信
影响因素30天-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%
5min142601-4260198.29997.081.4298.3097.081.41
242135-4213597.22497.22
342454-4245497.96097.96
441655-4165596.11696.12
542497-4249798.05998.06
641083-4108394.79794.80
10min141951-4195196.79996.671.7797.8997.751.76
242781-4278198.71599.79
342676-4267698.47299.56
441387-4138795.49896.57
541692-4169296.20297.29
640883-4088394.33595.39
15min141950-4195096.79795.431.1398.9697.581.12
241640-4164096.08298.26
341675-4167596.16398.35
441123-4112394.88997.02
540766-4076694.06596.22
640984-4098494.56896.67
20min141330-4133095.36794.061.1198.6197.271.11
241161-4116194.97798.22
340916-4091694.41197.66
440480-4048093.40596.59
540554-4055493.57696.78
640140-4014092.62195.77
30min138524-3852488.89292.262.6093.1996.522.49
241227-4122795.12999.43
340064-4006492.44596.75
439698-3969891.60195.82
541064-4106494.75399.00
639314-3931490.71594.90
45min140940-4094094.46792.712.0199.7698.001.94
240103-4010392.53597.89
340204-4020492.76898.10
439899-3989992.06597.30
541081-4108194.792100.09
638847-3884789.63794.83
极限140335-4033593.07191.321.4299.4197.641.37
239783-3978391.79798.18
340059-4005992.43498.79
439062-3906290.13396.40
539191-3919190.43196.78
639035-3903590.07196.26
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%
19.734082940684405204064640736406830.29
29.694099841000409990.01
单位质量响应值RSD%判断
4181.194231.060.84数据可信
影响因素30天-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%
5min147948-4794898.36297.671.1398.3697.671.13
247324-4732497.08297.08
348287-4828799.05899.06
448002-4800298.47398.47
546997-4699796.41196.41
647119-4711996.66296.66
10min146204-4620494.78596.532.3195.8897.612.29
247137-4713796.69997.78
347968-4796898.40399.50
448611-4861199.722100.82
546654-4665495.70896.78
645742-4574293.83794.91
15min145785-4578593.92595.282.5896.0797.432.55
246973-4697396.36298.52
347283-4728396.99899.19
447352-4735297.14099.34
546977-4697796.37098.50
644289-4428990.85692.97
20min145689-4568993.72894.481.0196.9297.701.02
246332-4633295.04798.27
346869-4686996.14999.42
445947-4594794.25797.54
545832-4583294.02197.23
645676-4567693.70196.83
30min145225-4522592.77693.781.9197.0198.051.89
245775-4577593.90598.18
346872-4687296.155100.50
446636-4663695.671100.00
544808-4480891.92196.17
644974-4497492.26196.43
45min144500-4450091.28992.551.3096.5597.861.31
245359-4535993.05198.37
345412-4541293.16098.57
445917-4591794.19699.59
545124-4512492.56997.84
644374-4437491.03096.22
极限144158-4415890.58790.762.3696.8697.092.29
244777-4477791.85798.21
344391-4439191.06597.51
445641-4564193.630100.07
543997-4399790.25796.56
642478-4247887.14193.34
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%
113.513668436663363533683837010367100.67
213.473634736630364880.55
单位质量响应值RSD%判断
2717.252708.830.22数据可信
影响因素30天-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%
5min141581-4158196.76896.641.7896.7796.641.78
240736-4073694.80194.80
342518-4251898.94898.95
441078-4107895.59795.60
542284-4228498.40498.40
640956-4095695.31395.31
10min140645-4064594.58995.753.0695.6696.823.04
241647-4164796.92197.97
342679-4267999.323100.42
440865-4086595.10196.16
541956-4195697.64098.73
639070-3907090.92491.98
15min140406-4040694.03394.813.1896.1696.953.15
241569-4156996.74098.87
341549-4154996.69398.90
441173-4117395.81897.94
541483-4148396.54098.72
638257-3825789.03291.10
20min139697-3969792.38393.502.0995.5596.682.09
240502-4050294.25797.46
341471-4147196.51299.79
439255-3925591.35594.54
540624-4062494.54197.79
639499-3949991.92294.98
30min139775-3977592.56592.812.4596.7697.042.41
240234-4023493.63397.89
341500-4150096.579100.93
439991-3999193.06797.27
539052-3905290.88295.18
638743-3874390.16394.24
45min138775-3877590.23892.552.2795.4697.812.25
239912-3991292.88498.18
340656-4065694.615100.04
440475-4047594.19499.43
540256-4025693.68499.00
638527-3852789.66094.74
极限138722-3872290.11490.922.0896.3497.202.07
239145-3914591.09997.42
340244-4024493.656100.13
439499-3949991.92298.20
538978-3897890.71097.06
637810-3781087.99294.07
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%
19.734071840866409114084540797408270.19
29.694073640856407960.21
单位质量响应值RSD%判断
4195.994210.110.24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%
5min147585-4758597.68696.711.8497.6996.711.84
245990-4599094.41294.41
347325-4732597.15297.15
446376-4637695.20495.20
546984-4698496.45296.45
648395-4839599.34999.35
10min147588-4758897.69297.121.5298.7898.201.52
246003-4600394.43895.49
347149-4714996.79197.87
447315-4731597.13298.19
548078-4807898.69899.77
647736-4773697.99699.10
15min147184-4718496.86396.581.2899.0398.731.27
246844-4684496.16598.26
347286-4728697.07299.23
445937-4593794.30396.44
547587-4758797.69099.86
647430-4743097.36899.56
20min146878-4687896.23495.681.5099.4898.901.49
245926-4592694.28097.45
346639-4663995.74498.98
445630-4563093.67296.86
547340-4734097.183100.44
647224-4722496.945100.22
30min146179-4617994.80094.881.2099.1299.171.19
246086-4608694.60998.82
346471-4647195.39999.70
445303-4530393.00197.23
546269-4626994.98499.32
646988-4698896.460100.81
45min145788-4578893.99793.771.5799.3799.121.55
244743-4474391.85297.12
345672-4567293.75999.12
444979-4497992.33697.60
546379-4637995.210100.60
646510-4651095.479100.90
极限145285-4528592.96493.811.0499.38100.201.04
245494-4549493.39399.68
345909-4590994.245100.64
445200-4520092.79099.07
545827-4582794.077100.52
646469-4646995.395101.88
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%
113.513720136773367853680836673368480.56
213.473729337394373440.20
单位质量响应值RSD%判断
2727.462772.381.16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%
5min141109-4110994.39294.262.5094.3994.262.50
239322-3932290.28990.29
341824-4182496.03496.03
440381-4038192.72192.72
541772-4177295.91595.91
641891-4189196.18896.19
10min141529-4152995.35794.902.6096.4195.942.59
239523-3952390.75191.75
341320-4132094.87795.94
441619-4161995.56396.59
542858-4285898.40899.47
641130-4113094.44095.51
15min140587-4058793.19493.972.0695.3096.072.05
240494-4049492.98094.99
341536-4153695.37397.49
439912-3991291.64493.74
542271-4227197.06099.22
640743-4074393.55295.67
20min140466-4046692.91693.802.2996.0696.952.27
240228-4022892.36995.41
340937-4093793.99797.18
439801-3980191.38994.50
542454-4245497.481100.72
641230-4123094.67097.83
30min138798-3879889.08692.012.0293.2696.191.98
240233-4023392.38196.45
341053-4105394.26498.49
439599-3959990.92595.05
540730-4073093.52297.84
640004-4000491.85596.06
45min139350-3935090.35391.211.6395.5296.421.64
238792-3879289.07294.17
339766-3976691.30896.58
439598-3959890.92396.06
540657-4065793.35498.71
640171-4017192.23897.47
极限139526-3952690.75791.402.3096.9397.622.23
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