培哚普利左氨氯地平项目信息
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%
19.604064840690407024066340629406660.08
29.584094340906409240.07
单位质量响应值RSD%判断
4236.044271.820.60数据可信
长期3月-供试品溶液-24050602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%
5min149408-49408100.21798.742.69100.2298.742.69
249808-49808101.028101.03
348167-4816797.69997.70
448968-4896899.32499.32
546277-4627793.86693.87
649459-49459100.320100.32
10min149102-4910299.59698.462.75100.7199.562.75
250156-50156101.734102.86
347842-4784297.04098.13
448556-4855698.48999.59
546317-4631793.94794.99
649272-4927299.941101.06
15min147893-4789397.14497.512.5499.3699.702.54
249376-49376100.152102.40
347998-4799897.35799.52
448623-4862398.624100.82
545844-4584492.98895.07
648720-4872098.821101.05
20min148641-4864198.66197.212.83101.96100.482.82
249005-4900599.399102.76
346859-4685995.04698.29
448661-4866198.701102.00
545657-4565792.60895.73
648733-4873398.848102.17
30min147125-4712595.58694.422.8599.9898.772.84
248028-4802897.418101.89
345432-4543292.15296.45
447027-4702795.38799.78
544461-4446190.18294.33
647214-4721495.766100.19
45min146691-4669194.70693.802.47100.1699.212.47
247220-4722095.779101.33
345535-4553592.36197.69
446269-4626993.85099.30
544369-4436989.99695.15
647394-4739496.132101.62
极限146359-4635994.03292.492.68100.5498.932.67
246915-4691595.160101.78
345081-4508191.44097.79
446016-4601693.33799.83
543441-4344188.11494.26
645771-4577192.84099.39
培哚普利左氨氯地平项目信息
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%
113.693805237957380763807638073380470.14
213.653824838163382060.16
单位质量响应值RSD%判断
2779.182798.970.51数据可信
长期3月-供试品溶液-24050602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%
5min143216-4321697.83297.362.9997.8397.362.99
242195-4219595.52095.52
341810-4181094.64994.65
442929-4292997.18297.18
545425-45425102.832102.83
642478-4247896.16196.16
10min143326-4332698.08197.243.9399.1798.323.92
242774-4277496.83197.89
340310-4031091.25392.30
442991-4299197.32298.40
545604-45604103.238104.38
642720-4272096.70997.78
15min142633-4263396.51297.012.9998.6999.172.99
242272-4227295.69597.83
341537-4153794.03196.10
443091-4309197.54999.71
545244-45244102.423104.71
642338-4233895.84497.99
20min142585-4258596.40396.022.6899.6599.262.69
242006-4200695.09398.29
340636-4063691.99195.10
442957-4295797.245100.49
544075-4407599.776103.20
642247-4224795.63898.85
30min141600-4160094.17493.643.1398.4997.953.13
241047-4104792.92297.18
339831-3983190.16994.30
441360-4136093.63097.96
543686-4368698.896103.43
640669-4066992.06696.34
45min141376-4137693.66692.962.6699.0398.302.67
240115-4011590.81296.10
340035-4003590.63195.77
440772-4077292.29997.66
543016-4301697.379103.01
641061-4106192.95398.25
极限141000-4100092.81592.092.8499.2298.472.84
240208-4020891.02297.32
339503-3950389.42695.57
440311-4031191.25597.65
542823-4282396.942103.66
640239-4023991.09297.42
培哚普利左氨氯地平项目信息
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%
19.604061240571405724055640568405760.06
29.584063340665406490.06
单位质量响应值RSD%判断
4226.674243.110.28数据可信
长期3月-供试品溶液-24050701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%
5min149520-49520100.89498.782.01100.8998.782.01
248514-4851498.84498.84
348130-4813098.06298.06
449735-49735101.332101.33
547571-4757196.92396.92
647419-4741996.61396.61
10min149090-49090100.01898.132.21101.1499.232.21
248598-4859899.016100.11
347818-4781897.42698.52
449453-49453100.758101.88
547299-4729996.36997.45
646724-4672495.19796.27
15min149113-49113100.06597.871.72102.30100.051.73
248016-4801697.830100.03
347712-4771297.21099.38
448924-4892499.680101.93
547302-4730296.37598.52
647133-4713396.03198.16
20min148168-4816898.13996.422.37101.4899.702.35
247711-4771197.208100.49
346469-4646994.67897.93
448912-4891299.655103.01
546705-4670595.15998.38
645994-4599493.71096.91
30min147101-4710195.96595.021.74100.4099.371.75
247074-4707495.910100.28
346317-4631794.36898.67
447667-4766797.119101.58
546299-4629994.33198.61
645369-4536992.43796.68
45min146761-4676195.27394.232.00100.7799.632.00
246694-4669495.136100.57
346078-4607893.88199.23
447416-4741696.607102.15
545778-4577893.27098.59
644768-4476891.21296.48
极限146159-4615994.04692.661.60100.6199.111.62
246013-4601393.749100.24
344816-4481691.31097.71
446239-4623994.209100.82
544840-4484091.35997.72
644803-4480391.28397.56
培哚普利左氨氯地平项目信息
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%
113.693811138126378323781238008379780.40
213.653786037937378980.15
单位质量响应值RSD%判断
2774.142776.410.06数据可信
长期3月-供试品溶液-24050701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%
5min142534-4253496.76697.712.1396.7797.712.13
244291-44291100.763100.76
342898-4289897.59497.59
443793-4379399.63099.63
542158-4215895.91095.91
642021-4202195.59895.60
10min143040-4304097.91797.562.4698.9998.642.46
244454-44454101.134102.25
342597-4259796.90997.99
443559-4355999.097100.20
542208-4220896.02497.09
641447-4144794.29395.35
15min143082-4308298.01297.361.93100.1899.521.94
244131-44131100.399102.64
342579-4257996.86899.03
443030-4303097.894100.10
542151-4215195.89498.03
641786-4178695.06497.17
20min142137-4213795.86295.712.5399.1198.962.51
243689-4368999.393102.75
341907-4190795.33998.58
442661-4266197.054100.35
541474-4147494.35497.55
640562-4056292.27995.45
30min141378-4137894.13694.382.3598.4598.692.34
243035-4303597.905102.37
341180-4118093.68597.98
441946-4194695.42899.80
541296-4129693.94998.20
640074-4007491.16995.36
45min141009-4100993.29693.472.3598.6698.842.35
242587-4258796.886102.44
341042-4104293.37198.71
441559-4155994.54799.98
540645-4064592.46897.76
639679-3967990.27095.47
极限140362-4036291.82492.052.6398.2298.452.60
242147-4214795.885102.51
339812-3981290.57396.95
441327-4132794.020100.50
539566-3956690.01396.33
639557-3955789.99396.20
培哚普利左氨氯地平项目信息
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%
19.604071040725407604076040783407480.08
29.584059640660406280.12
单位质量响应值RSD%判断
4244.584240.920.07数据可信
长期3月-供试品溶液-24050702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%
5min147698-4769897.00199.221.8197.0099.221.81
248419-4841998.46898.47
348250-4825098.12498.12
449130-4913099.91499.91
548997-4899799.64399.64
650245-50245102.181102.18
10min147344-4734496.28198.712.2097.3699.822.20
248418-4841898.46699.56
347845-4784597.30098.39
448254-4825498.13299.24
548968-4896899.584100.69
650407-50407102.511103.65
15min147020-4702095.62398.101.7797.77100.301.76
247871-4787197.35399.54
347750-4775097.10799.28
448469-4846998.569100.77
549186-49186100.027102.24
649132-4913299.918102.19
20min146518-4651894.60296.921.9797.81100.201.96
247247-4724796.08499.35
347078-4707895.74198.99
447714-4771497.034100.33
548231-4823198.085101.41
649153-4915399.960103.34
30min145847-4584793.23795.991.9997.50100.361.98
246474-4647494.51298.85
347022-4702295.62799.94
447762-4776297.132101.51
547723-4772397.052101.47
648387-4838798.403102.90
45min145374-4537492.27594.822.0097.57100.251.99
246334-4633494.22799.62
346068-4606893.68799.06
446721-4672195.015100.47
547195-4719595.978101.47
648047-4804797.711103.30
极限144875-4487591.26093.382.2397.5899.862.21
245429-4542992.38798.82
344955-4495591.42397.84
446132-4613293.817100.33
546651-4665194.872101.43
647460-4746096.517103.19
培哚普利左氨氯地平项目信息
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%
113.693802838113379183788837925379740.25
213.653795037909379300.08
单位质量响应值RSD%判断
2773.852778.750.13数据可信
长期3月-供试品溶液-24050702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%
5min143766-4376699.53297.711.2299.5397.711.21
243218-4321898.28598.29
342906-4290697.57697.58
442225-4222596.02796.03
542659-4265997.01497.01
643009-4300997.81097.81
10min143549-4354999.03897.141.85100.1498.221.84
243120-4312098.06399.15
342689-4268997.08298.17
441296-4129693.91494.98
542485-4248596.61897.70
643144-4314498.11799.20
15min143301-4330198.47496.721.37100.6898.891.37
242653-4265397.00099.18
342711-4271197.13299.30
441584-4158494.56996.68
542732-4273297.18099.33
642203-4220395.97798.15
20min142803-4280397.34295.551.42100.6498.791.42
242094-4209495.72998.99
342113-4211395.77299.01
440951-4095193.13096.29
542045-4204595.61898.85
642089-4208995.71898.96
30min142107-4210795.75994.521.10100.1498.821.10
241551-4155194.49498.82
341934-4193495.36599.67
440806-4080692.80097.00
541570-4157094.53898.83
641416-4141694.18798.49
45min141854-4185495.18393.321.64100.6398.681.62
241270-4127093.85599.23
341260-4126093.83399.20
439887-3988790.71095.94
540708-4070892.57797.92
641236-4123693.77899.13
极限141039-4103993.33091.881.2799.8398.271.28
240464-4046492.02298.44
340456-4045692.00498.41
439468-3946889.75795.99
540439-4043991.96598.34
640548-4054892.21398.61
培哚普利左氨氯地平项目信息
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%
19.604061540691406974065740638406600.09
29.584077040922408460.27
单位质量响应值RSD%判断
4235.424263.670.48数据可信
长期3月-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%
5min149070-4907099.63399.361.2199.6399.361.21
249163-4916399.82299.82
348371-4837198.21498.21
449835-49835101.186101.19
548978-4897899.44699.45
648206-4820697.87997.88
10min148844-4884499.17499.311.23100.28100.421.23
248572-4857298.62299.73
348780-4878099.044100.14
450090-50090101.704102.83
548773-4877399.030100.14
648408-4840898.28999.38
15min148248-4824897.96498.351.33100.17100.561.32
247979-4797997.41899.62
348545-4854598.567100.76
449589-49589100.687102.94
548520-4852098.516100.72
647755-4775596.96399.14
20min147289-4728996.01796.641.4399.3199.941.42
246729-4672994.88098.17
347524-4752496.49499.78
448780-4878099.044102.42
547787-4778797.028100.33
647459-4745996.36299.62
30min147170-4717095.77596.041.11100.14100.421.11
246638-4663894.69599.04
347511-4751196.468100.83
448075-4807597.613102.09
547558-4755896.563100.94
646853-4685395.13299.46
45min147035-4703595.50194.551.46100.9399.991.43
245972-4597293.34398.74
346153-4615393.71099.14
447653-4765396.756102.31
546622-4662294.663100.11
645971-4597193.34198.73
极限145842-4584293.07993.771.1899.57100.261.17
245429-4542992.24098.67
346319-4631994.047100.52
446957-4695795.343101.98
546550-4655094.516101.02
646000-4600093.40099.82
培哚普利左氨氯地平项目信息
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%
113.693799038010380143800938035380120.05
213.653807538055380650.04
单位质量响应值RSD%判断
2776.632788.640.31数据可信
长期3月-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%
5min143487-4348798.67296.082.4798.6796.082.47
243428-4342898.53998.54
341223-4122393.53593.54
442181-4218195.70995.71
542658-4265896.79196.79
641083-4108393.21893.22
10min143256-4325698.14895.851.5099.2496.921.51
242570-4257096.59297.69
341545-4154594.26695.31
442083-4208395.48796.55
542341-4234196.07297.15
641659-4165994.52595.56
15min142774-4277497.05595.211.5299.2497.341.52
242150-4215095.63997.81
341451-4145194.05396.14
441992-4199295.28097.40
542373-4237396.14598.29
641018-4101893.07095.16
20min141883-4188395.03393.721.1998.3096.901.20
241097-4109793.25096.48
340653-4065392.24295.37
441365-4136593.85897.04
541836-4183694.92698.14
640980-4098092.98496.10
30min141802-4180294.84993.071.2999.1797.301.30
241035-4103593.10997.38
340606-4060692.13596.29
440796-4079692.56796.79
541455-4145594.06298.33
640411-4041191.69395.85
45min141755-4175594.74391.392.30100.1296.652.25
240459-4045991.80297.10
339295-3929589.16194.34
440336-4033691.52396.78
540538-4053891.98197.29
639271-3927189.10694.28
极限140823-4082392.62890.761.3999.0697.041.40
239919-3991990.57796.90
339513-3951389.65595.83
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