培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.953980239924398083979539758398170.16
29.983977240187399800.74
单位质量响应值RSD%判断
4001.714006.010.08数据可信
长期12月-供试品溶液-2022081001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%
5min147053-47053100.26797.642.79100.2797.642.79
245824-4582497.64897.65
346688-4668899.49099.49
445488-4548896.93296.93
546376-4637698.82598.82
643487-4348792.66892.67
10min147074-47074100.312100.481.59101.43101.571.58
245808-4580897.61498.70
347417-47417101.043102.15
448074-48074102.443103.52
547424-47424101.058102.16
647131-47131100.434101.46
15min146864-4686499.86599.761.71102.09101.961.70
245272-4527296.47298.64
347377-47377100.958103.19
447266-47266100.721102.94
547360-47360100.922103.14
646759-4675999.641101.79
20min146819-4681999.76999.091.66103.11102.401.64
245171-4517196.25799.50
346117-4611798.273101.62
447293-47293100.779104.11
547070-47070100.304103.65
646544-4654499.183102.44
30min146301-4630198.66597.631.27103.11102.041.27
244794-4479495.45499.76
345667-4566797.314101.76
446379-4637998.831103.29
546036-4603698.100102.56
645726-4572697.440101.79
45min145442-4544296.83496.261.44102.38101.751.44
244028-4402893.82199.19
345498-4549896.954102.48
445905-4590597.821103.37
545269-4526996.466102.01
644889-4488995.656101.09
极限144724-4472495.30495.331.19101.92101.901.19
243949-4394993.653100.07
344840-4484095.552102.15
445562-4556297.090103.73
544862-4486295.598102.22
644479-4447994.782101.28
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.951608011609891608241605001610221608270.13
214.011612841610201611520.12
单位质量响应值RSD%判断
11528.8211502.640.17数据可信
长期12月-供试品溶液-2022081001批-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%
5min1173748-17374897.80896.362.2897.8196.362.28
2171595-17159596.59696.60
3173730-17373097.79797.80
4172978-17297897.37497.37
5171537-17153796.56396.56
6163494-16349492.03592.04
10min1176050-17605099.10399.852.29100.19100.922.28
2173629-17362997.74198.81
3178241-178241100.337101.42
4185055-185055104.173105.25
5176335-17633599.264100.34
6174988-17498898.50699.53
15min1175726-17572698.92199.461.65101.11101.641.65
2173015-17301597.39599.55
3178143-178143100.282102.48
4181512-181512102.178104.42
5176650-17665099.441101.62
6175098-17509898.567100.68
20min1175054-17505498.54398.332.46101.83101.622.43
2169559-16955995.44998.69
3172927-17292797.345100.66
4182537-182537102.755106.13
5174258-17425898.095101.38
6173771-17377197.820101.03
30min1172188-17218896.92997.181.83101.31101.561.82
2169906-16990695.64599.95
3171771-17177196.695101.09
4178859-178859100.685105.20
5171546-17154696.568100.94
6171501-17150196.543100.84
45min1167599-16759994.34695.301.8799.81100.761.86
2166986-16698694.00199.37
3169295-16929595.301100.77
4175556-17555698.825104.46
5167959-16795994.54999.99
6168354-16835494.771100.14
极限1166431-16643193.68994.761.82100.20101.281.81
2166201-16620193.55999.97
3167911-16791194.522101.05
4174295-17429598.115104.85
5166619-16661993.794100.29
6168535-16853594.873101.30
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.954000439965398434001140098399840.24
29.984010739849399780.46
单位质量响应值RSD%判断
4018.494005.810.23数据可信
长期12月-供试品溶液-2022081101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%
5min144962-4496295.61496.851.9595.6196.851.95
246718-4671899.34899.35
345023-4502395.74395.74
444380-4438094.37694.38
546146-4614698.13298.13
646023-4602397.87097.87
10min146228-4622898.30699.351.0599.37100.431.04
247221-47221100.418101.52
346972-4697299.888100.95
446734-4673499.382100.43
547133-47133100.230101.32
646039-4603997.90498.99
15min146684-4668499.27699.160.50101.43101.340.50
246751-4675199.418101.64
346554-4655498.999101.17
446599-4659999.095101.25
546940-4694099.820102.02
646250-4625098.353100.53
20min145749-4574997.28798.591.94100.55101.881.87
245897-4589797.602100.93
346237-4623798.325101.60
448107-48107102.302105.56
546432-4643298.740102.05
645758-4575897.306100.57
30min144964-4496495.61896.210.9999.96100.590.97
245579-4557996.926101.33
344553-4455394.74499.11
445266-4526696.260100.65
545818-4581897.434101.84
645288-4528896.307100.66
45min144422-4442294.46595.260.5599.87100.710.54
244724-4472495.108100.59
344860-4486095.397100.82
445115-4511595.939101.40
544978-4497895.648101.14
644676-4467695.006100.42
极限144377-4437794.37094.171.21100.82100.671.15
244735-4473595.131101.67
344537-4453794.710101.19
444490-4449094.610101.14
544318-4431894.244100.80
643229-4322991.92898.40
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.951612101608441610951605811606611608780.17
214.011617771611231614500.29
单位质量响应值RSD%判断
11532.4711523.910.06数据可信
长期12月-供试品溶液-2022081101批-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%
5min1164780-16478092.65995.451.6492.6695.451.63
2172363-17236396.92396.92
3168468-16846894.73394.73
4171565-17156596.47496.47
5170958-17095896.13396.13
6170372-17037295.80395.80
10min1172197-17219796.83098.411.3297.8699.471.32
2178072-178072100.133101.21
3176441-17644199.216100.27
4174640-17464098.20399.28
5176094-17609499.021100.09
6172561-17256197.03498.10
15min1174804-17480498.29598.580.53100.40100.730.53
2176220-17622099.092101.28
3174369-17436998.051100.21
4174318-17431898.022100.19
5175804-17580498.858101.03
6176327-17632799.152101.29
20min1170408-17040895.82497.831.3599.02101.081.33
2175009-17500998.411101.70
3173827-17382797.746100.99
4177536-17753699.832103.08
5174027-17402797.859101.13
6173053-17305397.311100.56
30min1167900-16790094.41395.320.9198.6899.660.89
2171745-17174596.575100.96
3168565-16856594.78799.12
4168359-16835994.67199.03
5169642-16964295.39399.75
6170857-17085796.076100.40
45min1164772-16477292.65493.351.6097.9798.751.53
2167831-16783194.37499.83
3167685-16768594.29299.68
4168375-16837594.680100.09
5166049-16604993.37298.79
6161356-16135690.73396.13
极限1165469-16546993.04692.651.7299.3999.081.63
2167987-16798794.462100.97
3166101-16610193.40299.83
4164694-16469492.61099.08
5164774-16477492.65599.11
6159543-15954389.71496.12
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.954080140621405914085640839407420.31
29.984014840039400940.20
单位质量响应值RSD%判断
4094.674017.431.35数据可信
长期12月-供试品溶液-2022081201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%
5min145398-4539895.50495.632.2895.5095.632.28
246349-4634997.50597.50
346042-4604296.85996.86
445769-4576996.28596.28
543445-4344591.39691.40
645744-4574496.23296.23
10min147517-4751799.96298.830.75101.0299.890.72
246634-4663498.10599.19
346867-4686798.59599.67
446777-4677798.40599.48
547301-4730199.508100.52
646766-4676698.38299.45
15min147099-4709999.08396.763.70101.2598.923.61
247279-4727999.461101.63
345057-4505794.78796.96
443074-4307490.61592.78
547464-4746499.851101.97
646004-4600496.77998.94
20min145777-4577796.30295.570.8199.5798.800.81
245894-4589496.54899.83
345109-4510994.89698.12
445428-4542895.56798.74
544948-4494894.55897.79
645415-4541595.54098.78
30min145118-4511894.91594.821.2199.2699.121.15
245108-4510894.89499.25
344191-4419192.96597.24
445440-4544095.59399.82
545772-4577296.291100.57
644804-4480494.25598.55
45min141643-4164387.60593.113.1693.0098.462.98
245008-4500894.684100.09
343750-4375092.03797.35
444696-4469694.02899.32
545323-4532395.347100.70
645149-4514994.981100.33
极限144251-4425193.09192.023.4899.4698.403.29
244668-4466893.969100.43
340778-4077885.78592.12
444078-4407892.72799.07
544988-4498894.642101.05
643679-4367991.88898.29
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.951636101643251640951639791639731639960.16
214.011612961618811615880.26
单位质量响应值RSD%判断
11755.9911533.761.35数据可信
长期12月-供试品溶液-2022081201批-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%
5min1164038-16403891.32693.042.4791.3393.042.47
2170194-17019494.75394.75
3170138-17013894.72294.72
4168327-16832793.71393.71
5160207-16020789.19389.19
6169840-16984094.55694.56
10min1174928-17492897.38896.760.6798.4097.790.68
2173401-17340196.53897.59
3174957-17495797.40598.46
4173683-17368396.69597.74
5171836-17183695.66796.66
6173945-17394596.84197.89
15min1174931-17493197.39096.081.3699.4998.191.32
2174755-17475597.29299.42
3168723-16872393.93496.07
4171884-17188495.69497.81
5173513-17351396.60198.65
6171698-17169895.59097.72
20min1169072-16907294.12893.961.0597.3197.141.04
2170828-17082895.10698.31
3169182-16918294.18997.37
4168747-16874793.94797.13
5165501-16550192.14095.27
6169312-16931294.26297.45
30min1167149-16714993.05893.210.6797.2897.430.62
2166882-16688292.90997.17
3166165-16616592.51096.73
4168619-16861993.87698.10
5168985-16898594.08098.23
6166748-16674892.83497.07
45min1163711-16371191.14492.141.0096.4097.400.94
2164810-16481091.75597.05
3163861-16386191.22796.48
4166059-16605992.45197.72
5166778-16677892.85198.05
6167762-16776293.39998.67
极限1163391-16339190.96591.380.7897.2497.660.72
2165624-16562492.20998.52
3162854-16285490.66696.93
4163605-16360591.08597.38
5165852-16585292.33698.56
6163541-16354191.04997.35
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