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%
19.603968639667397893962839711396960.16
29.583997040081400260.20
单位质量响应值RSD%判断
4135.004178.080.74数据可信
加速3月-供试品溶液-24050602批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146940-4694097.44298.231.6097.4498.231.60
248516-48516100.714100.71
346930-4693097.42297.42
447946-4794699.53199.53
547103-4710397.78197.78
646491-4649196.51096.51
10min146949-4694997.46198.311.3998.5499.401.39
247972-4797299.585100.70
347203-4720397.98899.07
448252-48252100.166101.27
547305-4730598.20099.29
646471-4647196.46997.54
15min146468-4646896.46396.491.2098.6398.681.20
247330-4733098.252100.48
346844-4684497.24399.41
446306-4630696.12698.35
546261-4626196.03398.21
645692-4569294.85297.00
20min146334-4633496.18496.021.0299.4299.281.02
246633-4663396.805100.12
346058-4605895.61198.86
446883-4688397.324100.61
546074-4607495.64598.89
645560-4556094.57897.78
30min145470-4547094.39194.441.6598.7098.761.62
245889-4588995.26199.65
345149-4514993.72498.04
446347-4634796.211100.58
545888-4588895.25999.57
644209-4420991.77396.02
45min144385-4438592.13992.901.7997.4998.271.74
244706-4470692.80598.26
344633-4463392.65398.01
446231-4623195.971101.41
544725-4472592.84498.21
643833-4383390.99396.26
极限144457-4445792.28891.631.7898.6798.031.67
245399-4539994.243100.73
344014-4401491.36897.75
443053-4305389.37395.88
544181-4418191.71598.11
643725-4372590.76897.05
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%
113.693763637390376123743137522375180.29
213.653765737836377460.34
单位质量响应值RSD%判断
2740.542765.270.64数据可信
加速3月-供试品溶液-24050602批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133542-3354276.93077.083.1776.9377.083.17
233764-3376477.43977.44
334796-3479679.80679.81
433020-3302075.73375.73
534611-3461179.38279.38
631912-3191273.19273.19
10min137390-3739085.75687.212.6886.6188.072.68
237900-3790086.92587.79
339797-3979791.27692.16
438031-3803187.22688.07
538258-3825887.74788.63
636769-3676984.33185.14
15min137443-3744385.87787.302.8987.6889.122.88
237714-3771486.49988.33
340248-4024892.31194.21
437804-3780486.70588.52
537902-3790286.93088.79
637260-3726085.45887.21
20min137775-3777586.63987.592.1289.4090.392.14
237795-3779586.68589.47
339777-3977791.23094.16
437798-3779886.69289.47
538315-3831587.87790.70
637687-3768786.43789.14
30min136826-3682684.46286.572.5488.1990.342.53
237392-3739285.76089.51
339534-3953490.67394.61
437762-3776286.60990.35
537843-3784386.79590.59
637113-3711385.12088.78
45min136708-3670884.19286.512.8288.8591.242.79
237075-3707585.03389.74
339436-3943690.44895.40
438296-3829687.83492.53
537989-3798987.13091.89
636801-3680184.40589.01
极限138720-3872088.80689.912.1194.4095.602.13
238864-3886489.13694.78
340674-4067493.28899.24
439354-3935490.26095.94
539312-3931290.16495.90
638280-3828087.79793.34
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%
19.603957839509394413948739368394770.20
29.583996839930399490.07
单位质量响应值RSD%判断
4112.194170.040.99数据可信
加速3月-供试品溶液-24050701批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147287-4728798.53197.721.6398.5397.721.63
247005-4700597.94397.94
347023-4702397.98097.98
447493-4749398.96098.96
545386-4538694.56994.57
647190-4719098.32898.33
10min147348-4734898.65896.782.4599.7597.862.43
246911-4691197.74798.84
347495-4749598.964100.05
446526-4652696.94598.04
545981-4598195.80996.86
644421-4442192.55993.65
15min147317-4731798.59396.951.56100.7899.121.55
246442-4644296.77098.94
347182-4718298.312100.50
446428-4642896.74198.92
545281-4528194.35196.47
646533-4653396.95999.08
20min146376-4637696.63296.001.0599.9299.241.06
246109-4610996.07699.33
346718-4671897.345100.63
445951-4595195.74799.00
545280-4528094.34997.51
646000-4600095.84999.05
30min146007-4600795.86394.801.12100.2299.101.11
245482-4548294.77099.09
345655-4565595.13099.49
445367-4536794.53098.85
544584-4458492.89897.11
645885-4588595.60999.87
45min145020-4502093.80793.791.0699.2399.141.03
245299-4529994.38899.76
345014-4501493.79499.21
444722-4472293.18698.55
544311-4431192.33097.57
645699-4569995.222100.55
极限144961-4496193.68492.801.13100.1599.211.12
244733-4473393.20999.63
344859-4485993.47199.93
444061-4406191.80998.21
543757-4375791.17597.45
644864-4486493.48299.87
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%
113.693781937990376743767738088378500.50
213.653759137578375840.03
单位质量响应值RSD%判断
2764.792753.410.30数据可信
加速3月-供试品溶液-24050701批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135604-3560481.47582.061.2081.4782.061.21
235834-3583482.00182.00
335300-3530080.77980.78
436140-3614082.70182.70
536535-3653583.60583.61
635757-3575781.82581.83
10min137595-3759586.03185.791.1886.9486.701.17
237176-3717685.07285.98
337321-3732185.40486.30
437209-3720985.14886.07
538332-3833287.71888.65
637294-3729485.34286.25
15min137736-3773686.35486.170.8288.2188.030.81
237632-3763286.11687.97
337588-3758886.01587.86
437132-3713284.97286.84
537760-3776086.40988.31
638079-3807987.13989.00
20min137347-3734785.46485.691.0788.2888.521.05
237126-3712684.95887.77
337786-3778686.46889.27
437042-3704284.76687.57
538065-3806587.10789.97
637319-3731985.39988.23
30min137179-3717985.07985.360.9288.8589.140.91
236879-3687984.39388.15
337484-3748485.77789.54
436969-3696984.59988.35
537699-3769986.26990.10
637607-3760786.05989.83
45min137022-3702284.72085.320.8989.4490.040.87
237010-3701084.69289.39
336956-3695684.56989.28
437426-3742685.64490.34
537748-3774886.38191.17
637533-3753385.88990.62
极限138752-3875288.67988.111.5294.3493.781.47
238035-3803587.03892.67
338321-3832187.69293.35
437830-3783086.56992.21
539464-3946490.30896.06
638617-3861788.37094.05
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%
19.603980039724398063974339809397760.11
29.584012240195401580.13
单位质量响应值RSD%判断
4143.334191.860.83数据可信
加速3月-供试品溶液-24050702批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148747-48747100.92698.341.72100.9398.341.72
246924-4692497.15197.15
346729-4672996.74896.75
446784-4678496.86296.86
547950-4795099.27699.28
647850-4785099.06999.07
10min149696-49696102.89198.122.74104.0199.212.72
246160-4616095.57096.65
347474-4747498.29099.37
446170-4617095.59096.67
547618-4761898.58899.69
647225-4722597.77598.88
15min148181-4818199.75497.241.91102.0299.421.91
246906-4690697.11499.26
346205-4620595.66397.83
445720-4572094.65996.80
547260-4726097.847100.05
647514-4751498.373100.56
20min147873-4787399.11696.371.80102.4999.641.81
245827-4582794.88098.10
346066-4606695.37598.61
445694-4569494.60597.80
546927-4692797.158100.44
646902-4690297.106100.39
30min146966-4696697.23894.562.03101.7198.902.02
245606-4560694.42398.70
344896-4489692.95397.24
444393-4439391.91196.15
546084-4608495.41299.78
646096-4609695.43799.80
45min146372-4637296.00992.922.19101.5698.302.16
244124-4412491.35496.68
343753-4375390.58695.91
444349-4434991.82097.08
545233-4523393.65099.08
645439-4543994.07799.50
极限146235-4623595.72592.062.42102.3598.482.39
243465-4346589.99096.33
343869-4386990.82697.16
443514-4351490.09196.37
544636-4463692.41498.88
645068-4506893.30999.77
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%
113.693737737709374473751137544375180.34
213.653770337735377190.06
单位质量响应值RSD%判断
2740.542763.300.59数据可信
加速3月-供试品溶液-24050702批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134445-3444579.02979.721.8079.0379.721.80
234223-3422378.52078.52
334478-3447879.10579.11
435363-3536381.13681.14
534272-3427278.63278.63
635691-3569181.88881.89
10min137078-3707885.07083.822.8685.9584.712.84
235612-3561281.70782.58
335792-3579282.12083.00
437140-3714085.21386.11
535521-3552181.49882.37
638062-3806287.32888.24
15min136373-3637383.45383.813.4885.2885.633.45
236496-3649683.73585.52
334981-3498180.25982.05
436845-3684584.53686.38
535734-3573481.98783.77
638748-3874888.90290.78
20min136564-3656483.89183.672.7286.6486.422.71
236148-3614882.93785.65
335191-3519180.74183.42
436962-3696284.80487.59
535881-3588182.32485.01
638068-3806887.34290.21
30min135595-3559581.66882.373.0785.3586.043.04
235577-3557781.62785.26
334769-3476979.77383.35
436216-3621683.09386.82
535310-3531081.01484.62
637929-3792987.02390.86
45min135779-3577982.09082.213.5086.6886.803.46
235522-3552281.50086.04
334261-3426178.60783.07
436631-3663184.04588.70
534973-3497380.24184.75
637811-3781186.75291.56
极限138748-3874888.90287.681.6894.4093.191.66
237565-3756586.18891.63
337536-3753686.12191.46
439142-3914289.80695.39
538104-3810487.42492.82
638204-3820487.65493.42
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%
19.603968039805397783973639729397460.13
29.584007540063400690.03
单位质量响应值RSD%判断
4140.214182.570.72数据可信
加速3月-供试品溶液-2024052721批-培哚普利-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147231-4723197.93297.321.5797.9397.321.58
247845-4784599.20599.21
347187-4718797.84197.84
445678-4567894.71294.71
546583-4658396.58996.59
647100-4710097.66197.66
10min147357-4735798.19397.311.0299.2898.391.03
247527-4752798.54699.65
346971-4697197.39398.48
446187-4618795.76796.82
546743-4674396.92097.99
646806-4680697.05198.14
15min147179-4717997.82496.471.76100.0098.631.75
247452-4745298.390100.59
346742-4674296.91899.09
445148-4514893.61395.73
546397-4639796.20398.35
646233-4623395.86398.03
20min146497-4649796.41095.411.1699.6898.641.17
246389-4638996.18699.48
346297-4629795.99699.24
445062-4506293.43596.59
546045-4604595.47398.69
645794-4579494.95398.18
30min145855-4585595.07994.501.3999.4298.801.38
246425-4642596.261100.62
345686-4568694.72999.04
444502-4450292.27496.47
545440-4544094.21998.50
645558-4555894.46398.75
45min145034-4503493.37792.681.2498.7798.021.23
244733-4473392.75398.18
345182-4518293.68499.05
443630-4363090.46695.69
544903-4490393.10598.43
644697-4469792.67898.01
极限145383-4538394.10092.272.61100.5398.652.51
244745-4474592.77899.24
345128-4512893.57299.98
442296-4229687.70093.92
544227-4422791.70398.06
645235-4523593.794100.16
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%
113.693745637495375503757637425375000.17
213.653752437729376260.39
单位质量响应值RSD%判断
2739.232756.480.45数据可信
加速3月-供试品溶液-2024052721批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132727-3272775.19876.573.6575.2076.573.65
233589-3358977.17977.18
332910-3291075.61975.62
434022-3402278.17478.17
531579-3157972.56072.56
635124-3512480.70680.71
10min135711-3571182.05581.933.9282.8982.783.92
235334-3533481.18882.05
335053-3505380.54381.38
436238-3623883.26684.13
533697-3369777.42778.23
637916-3791687.12188.02
15min136239-3623983.26881.923.5885.0283.683.58
235765-3576582.17983.94
335528-3552881.63483.37
435840-3584082.35184.14
533341-3334176.60978.28
637198-3719885.47187.34
20min135854-3585482.38381.903.1885.0684.573.19
235299-3529981.10883.78
335396-3539681.33183.97
436335-3633583.48886.20
533807-3380777.68080.20
637168-3716885.40288.22
30min135542-3554281.66681.743.4685.2585.323.46
235722-3572282.08085.65
335551-3555181.68785.23
435811-3581182.28485.92
533488-3348876.94780.33
637343-3734385.80589.57
45min135286-3528681.07880.744.0785.5785.224.03
234498-3449879.26783.75
335411-3541181.36585.82
435708-3570882.04886.60
532804-3280475.37579.61
637116-3711685.28390.00
极限138553-3855388.58587.342.7793.9892.732.76
238136-3813687.62792.99
338067-3806787.46892.83
436861-3686184.69790.16
536846-3684684.66389.74
639608-3960891.00996.67
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