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%
19.603914639109391923913839025391220.16
29.583925139233392420.04
单位质量响应值RSD%判断
4075.214096.240.37数据可信
加速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%
5min147366-47366100.02998.401.07100.0398.401.07
246051-4605197.25297.25
346238-4623897.64797.65
446688-4668898.59798.60
546923-4692399.09399.09
646290-4629097.75797.76
10min146815-4681598.86597.880.9499.9898.970.95
245911-4591196.95698.04
345915-4591596.96598.05
446638-4663898.49299.59
546763-4676398.75699.86
646042-4604297.23398.32
15min146815-4681598.86596.771.51101.0898.951.50
245065-4506595.17097.33
345234-4523495.52797.69
446482-4648298.162100.35
545699-4569996.50998.71
645635-4563596.37398.54
20min145891-4589196.91495.810.98100.2299.070.98
244789-4478994.58797.80
345419-4541995.91799.14
445601-4560196.30299.58
545637-4563796.37899.65
644877-4487794.77398.01
30min144897-4489794.81593.790.7899.2098.110.80
243944-4394492.80297.07
344195-4419593.33297.62
444641-4464194.27498.62
544548-4454894.07898.42
644247-4424793.44297.73
45min144912-4491294.84792.571.42100.2997.931.39
243526-4352691.92097.22
343359-4335991.56796.89
443696-4369692.27997.68
544194-4419493.33098.72
643303-4330391.44996.78
极限144146-4414693.22992.221.0799.7298.611.06
243088-4308890.99597.31
343426-4342691.70898.05
444297-4429793.54899.97
543629-4362992.13798.56
643432-4343291.72198.07
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%
113.693720337134370793729436976371370.33
213.653722637254372400.06
单位质量响应值RSD%判断
2712.712728.210.41数据可信
加速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%
5min142035-4203597.55897.041.4097.5697.041.40
242021-4202197.52697.53
340956-4095695.05495.05
441550-4155096.43296.43
542691-4269199.08199.08
641627-4162796.61196.61
10min141826-4182697.07397.442.3198.1698.522.29
243129-43129100.097101.18
340525-4052594.05495.11
441854-4185497.13898.21
542994-4299499.784100.88
641579-4157996.50097.57
15min141451-4145196.20396.361.6298.3798.521.62
242408-4240898.424100.62
340441-4044193.85995.96
441860-4186097.15299.30
541769-4176996.94199.15
641180-4118095.57497.72
20min141355-4135595.98095.771.4399.2199.001.43
242203-4220397.948101.24
340596-4059694.21897.36
441125-4112595.44698.68
541564-4156496.46599.75
640738-4073894.54897.76
30min140166-4016693.22093.011.8497.5297.301.82
240968-4096895.08299.46
339200-3920090.97895.17
439832-3983292.44596.74
540870-4087094.85499.21
639413-3941391.47395.73
45min140299-4029993.52992.061.9798.8697.391.94
240605-4060594.23999.67
338747-3874789.92795.13
439336-3933691.29496.61
540117-4011793.10798.52
638892-3889290.26495.54
极限139458-3945891.57791.581.8097.9597.941.78
240469-4046993.924100.40
338283-3828388.85095.05
439441-3944191.53897.87
539769-3976992.29998.75
639346-3934691.31797.59
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%
19.603909039130392583918839259391850.20
29.583914939067391080.15
单位质量响应值RSD%判断
4081.774082.250.01数据可信
加速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%
5min149572-49572104.782101.771.89104.78101.771.89
247435-47435100.265100.27
348133-48133101.740101.74
447829-47829101.098101.10
548798-48798103.146103.15
647116-4711699.59199.59
10min148779-48779103.106100.911.56104.27102.041.57
247191-4719199.749100.86
347507-47507100.417101.55
448131-48131101.736102.86
548108-48108101.688102.83
646716-4671698.74599.85
15min148458-48458102.42798.752.14104.74101.002.13
245940-4594097.10599.33
346533-4653398.359100.60
446825-4682598.976101.23
546945-4694599.229101.51
645611-4561196.41098.61
20min147482-47482100.36490.4520.41103.8193.8019.67
245692-4569296.58199.88
346079-4607997.399100.74
446877-4687799.086102.44
525030-2503052.90756.29
645585-4558596.35599.63
30min147328-47328100.03996.672.46104.60101.032.35
245281-4528195.712100.09
344994-4499495.10599.53
445891-4589197.001101.46
546644-4664498.593102.56
644268-4426893.57197.92
45min146843-4684399.01496.752.18104.69102.182.05
245960-4596097.147102.59
344732-4473294.552100.03
445717-4571796.634102.17
546847-4684799.022104.08
644536-4453694.13799.52
极限145587-4558796.35995.011.40103.13101.521.30
244014-4401493.03499.55
344900-4490094.907101.44
444905-4490594.917101.52
545692-4569296.581102.74
644605-4460594.283100.71
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%
113.693703637050372203706237073370880.21
213.653704537118370820.14
单位质量响应值RSD%判断
2709.132716.630.20数据可信
加速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%
5min142912-4291299.87197.621.3299.8797.611.32
241315-4131596.15496.15
342196-4219698.20598.20
441714-4171497.08397.08
541784-4178497.24697.25
641735-4173597.13297.13
10min142273-4227398.38497.091.1999.4998.181.18
241327-4132796.18297.25
341570-4157096.74897.84
442391-4239198.65899.74
541212-4121295.91597.00
641541-4154196.68097.76
15min142081-4208197.93795.431.61100.1497.601.60
240323-4032393.84695.98
340609-4060994.51196.68
441391-4139196.33198.51
540527-4052794.32096.47
641100-4110095.65497.81
20min141377-4137796.29997.176.2499.59100.396.03
240034-4003493.17396.35
340096-4009693.31796.53
441107-4110795.67098.92
546945-46945109.257112.45
640944-4094495.29198.51
30min140990-4099095.39893.001.6999.7697.311.67
239338-3933891.55395.77
339394-3939491.68395.94
440510-4051094.28198.59
540017-4001793.13397.54
639521-3952191.97996.25
45min140815-4081594.99193.141.59100.4198.471.53
240533-4053394.33499.57
339007-3900790.78396.05
439978-3997893.04398.40
540039-4003993.18598.63
639738-3973892.48497.78
极限139780-3978092.58291.321.6099.0697.691.53
238177-3817788.85195.13
339168-3916891.15797.44
439389-3938991.67298.06
539002-3900290.77197.25
639916-3991692.89899.22
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%
19.603926539138390073917939139391460.24
29.583912439179391520.10
单位质量响应值RSD%判断
4077.714086.850.16数据可信
加速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%
5min147414-47414100.21499.521.88100.2199.521.88
247671-47671100.758100.76
347189-4718999.73999.74
447592-47592100.591100.59
547317-47317100.009100.01
645322-4532295.79395.79
10min147582-47582100.56998.821.53101.6899.921.53
247000-4700099.339100.46
346496-4649698.27499.38
446932-4693299.196100.31
547024-4702499.390100.50
645479-4547996.12597.19
15min146778-4677898.87097.751.62101.1099.951.62
246338-4633897.940100.16
346429-4642998.132100.33
446270-4627097.796100.02
546870-4687099.065101.28
644803-4480394.69696.83
20min146956-4695699.24696.762.13102.58100.052.11
245721-4572196.63699.95
345935-4593597.088100.38
445492-4549296.15299.46
546461-4646198.200101.52
644111-4411193.23396.42
30min146072-4607297.37895.601.83101.8199.961.82
245842-4584296.892101.28
345335-4533595.820100.19
444982-4498295.07499.45
545398-4539895.953100.36
643742-4374292.45396.67
45min145544-4554496.26294.822.00101.78100.241.98
245213-4521395.562101.02
345116-4511695.357100.79
444931-4493194.966100.40
545275-4527595.693101.17
643082-4308291.05896.31
极限144477-4447794.00793.241.95100.5999.721.93
244686-4468694.448100.97
344597-4459794.260100.75
443989-4398992.97599.46
544491-4449194.036100.57
642436-4243689.69395.95
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%
113.693694637141369213704037141370380.29
213.653719437201371980.02
单位质量响应值RSD%判断
2705.482725.130.52数据可信
加速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%
5min141559-4155996.63796.831.7996.6496.831.78
242770-4277099.45399.45
341489-4148996.47496.47
442181-4218198.08398.08
541200-4120095.80295.80
640661-4066194.54994.55
10min141931-4193197.50296.261.2498.5897.331.24
241638-4163896.82197.93
341769-4176997.12598.20
441435-4143596.34997.44
540575-4057594.34995.41
641022-4102295.38896.44
15min141238-4123895.89095.040.9698.0597.190.96
241364-4136496.18398.36
340534-4053494.25396.40
441003-4100395.34497.50
540695-4069594.62896.74
640407-4040793.95896.07
20min141279-4127995.98693.861.2199.2197.061.19
240423-4042393.99597.24
340378-4037893.89197.09
440062-4006293.15696.38
540095-4009593.23396.40
639942-3994292.87796.03
30min141028-4102895.40293.081.7099.6997.331.66
240759-4075994.77799.07
339633-3963392.15896.40
439664-3966492.23096.49
539639-3963992.17296.37
639459-3945991.75495.94
45min140397-4039793.93592.491.3799.2897.771.35
240411-4041193.96799.31
339569-3956992.01097.28
439843-3984392.64797.93
539304-3930491.39396.62
639135-3913591.00096.21
极限139612-3961292.11090.881.4498.5097.191.41
239869-3986992.70799.10
339164-3916491.06897.36
438560-3856089.66395.97
538729-3872990.05696.30
638566-3856689.67795.89
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%
19.603913839166391773929439343392240.23
29.583913539227391810.17
单位质量响应值RSD%判断
4085.834089.870.07数据可信
加速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%
5min147496-47496100.25199.381.09100.2599.381.08
246911-4691199.01699.02
347126-4712699.47099.47
446215-4621597.54797.55
547668-47668100.614100.61
647092-4709299.39899.40
10min147291-4729199.81898.921.01100.93100.021.00
246406-4640697.95099.05
346877-4687798.944100.05
446316-4631697.76098.84
546802-4680298.78699.90
647505-47505100.270101.37
15min146813-4681398.80998.041.03101.03100.241.01
245964-4596497.01799.21
346657-4665798.480100.68
446446-4644698.034100.20
545810-4581096.69298.91
647004-4700499.212101.43
20min146845-4684598.87797.550.86102.20100.850.86
246289-4628997.703100.97
345950-4595096.987100.29
445663-4566396.38299.64
546245-4624597.610100.90
646319-4631997.766101.09
30min145927-4592796.93995.470.77101.3699.840.76
245133-4513395.26399.62
345171-4517195.34399.72
445056-4505695.10099.43
545037-4503795.06099.43
645052-4505295.09299.50
45min145553-4555396.14994.441.80101.6599.881.73
244537-4453794.00599.42
344754-4475494.46399.90
444438-4443893.79699.18
543492-4349291.79997.23
645681-4568196.420101.88
极限145386-4538695.79793.173.13102.3699.662.92
244604-4460494.146100.60
344511-4451193.950100.44
443759-4375992.36398.79
545035-4503595.056101.51
641555-4155587.71194.25
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%
113.693708937287373163719237157372080.26
213.653717437162371680.03
单位质量响应值RSD%判断
2717.902722.930.14数据可信
加速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%
5min141791-4179196.99398.301.9096.9998.301.91
242898-4289899.56299.56
341596-4159696.54096.54
441709-4170996.80296.80
543619-43619101.235101.24
642525-4252598.69698.70
10min142064-4206497.62697.961.6698.7099.051.66
242393-4239398.39099.50
341255-4125595.74996.82
441626-4162696.61097.69
542842-4284299.432100.56
643061-4306199.940101.04
15min141799-4179997.01196.801.3199.1798.981.31
241851-4185197.13299.33
340945-4094595.02997.17
441341-4134195.94898.10
541745-4174596.88699.12
642565-4256598.789101.00
20min141435-4143596.16696.111.9299.4199.371.90
242155-4215597.837101.12
340287-4028793.50296.69
440640-4064094.32197.54
542189-4218997.916101.22
641758-4175896.916100.22
30min140413-4041393.79494.031.8798.1098.361.86
241277-4127795.800100.17
339317-3931791.25195.48
440082-4008293.02697.29
541298-4129895.848100.24
640705-4070594.47298.85
45min140558-4055894.13193.691.4999.4899.061.49
240892-4089294.906100.34
339606-3960691.92197.17
439615-3961591.94297.24
540685-4068594.42699.88
640848-4084894.804100.24
极限140422-4042293.81592.393.56100.2198.803.36
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