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%
110.464304042981429184314843111430400.22
210.474304543183431140.23
单位质量响应值RSD%判断
4114.724117.860.06数据可信
供试品溶液-322765批-培哚普利-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min143850-4385090.89087.7610.7990.8987.7610.79
247204-4720497.84297.84
344877-4487793.01893.02
444764-4476492.78492.78
537606-3760677.94777.95
635732-3573274.06374.06
10min146906-4690697.22497.481.3398.2398.461.37
248282-48282100.076101.16
346829-4682997.06498.10
446563-4656396.51397.54
546776-4677696.95497.82
646827-4682797.06097.88
15min145778-4577894.88697.812.0396.9899.871.97
248340-48340100.196102.40
346622-4662296.63598.75
446856-4685697.12099.22
548019-4801999.531101.47
647524-4752498.505100.41
20min145826-4582694.98596.952.1398.13100.092.07
248021-4802199.535102.85
345885-4588595.10898.29
446060-4606095.47098.65
547846-4784699.172102.22
646996-4699697.410100.41
30min145825-4582594.98396.681.9299.18100.901.84
247259-4725997.956102.37
345979-4597995.30299.54
445961-4596195.26599.51
548059-4805999.614103.76
646765-4676596.932101.01
45min145472-4547294.25295.702.7799.51101.002.64
247146-4714697.721103.23
345249-4524993.78999.09
444788-4478892.83498.14
548152-4815299.807105.06
646226-4622695.814100.97
极限145066-4506693.41094.312.1699.71100.672.09
246459-4645996.297102.89
344133-4413391.47697.82
445206-4520693.700100.03
546809-4680997.023103.39
645322-4532293.941100.16
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4000
标示量(mg)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%
113.818101381105807628058781298809530.35
213.898037880836806070.41
单位质量响应值RSD%判断
5861.915803.240.72数据可信
供试品溶液-322765批-氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min178670-7867087.43983.709.2987.4483.709.29
281527-8152790.61490.61
380093-8009389.02089.02
478684-7868487.45487.45
567703-6770375.24975.25
665184-6518472.44972.45
10min185712-8571295.26594.151.5696.2495.081.62
285804-8580495.36896.37
385352-8535294.86595.85
485186-8518694.68195.65
582550-8255091.75192.59
683649-8364992.97393.78
15min183916-8391693.26994.610.8395.3096.590.77
285519-8551995.05197.12
384830-8483094.28596.33
485272-8527294.77696.80
585248-8524894.75096.61
685975-8597595.55897.40
20min183756-8375693.09193.660.8696.1696.680.79
285001-8500194.47597.60
383349-8334992.63995.73
483811-8381193.15396.23
585054-8505494.53497.44
684623-8462394.05596.95
30min183584-8358492.90093.750.8197.0097.820.73
284732-8473294.17698.35
384191-8419193.57597.70
483540-8354092.85196.96
585030-8503094.50798.47
685024-8502494.50198.45
45min183016-8301692.26992.441.5997.4097.541.46
283162-8316292.43197.65
382580-8258091.78496.94
481700-8170090.80695.95
585629-8562995.173100.18
682915-8291592.15797.15
极限181856-8185690.98090.931.0797.1497.070.98
282010-8201091.15197.40
380400-8040089.36195.54
481782-8178290.89797.05
583131-8313192.39798.46
681713-8171390.82196.84
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%
110.464287342882428564293443033429160.17
210.474304643147430960.17
单位质量响应值RSD%判断
4102.874116.140.23数据可信
供试品溶液-2021561批-培哚普利-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min142862-4286288.98996.384.4888.9996.384.48
247844-4784499.33299.33
345327-4532794.10694.11
446677-4667796.90996.91
548686-48686101.080101.08
647151-4715197.89397.89
10min146666-4666696.886101.102.4297.88102.172.42
249707-49707103.200104.30
349692-49692103.169104.21
448053-4805399.766100.84
549287-49287102.328103.45
648766-48766101.246102.33
15min146850-4685097.268100.792.6199.33102.982.62
249490-49490102.750105.00
349242-49242102.235104.43
447093-4709397.77399.96
549812-49812103.418105.68
648778-48778101.271103.48
20min146608-4660896.76699.712.4799.91103.032.46
249088-49088101.915105.31
349272-49272102.297105.62
446560-4656096.66699.94
548352-48352100.387103.80
648289-48289100.256103.59
30min145842-4584295.17699.162.3699.40103.592.37
248497-48497100.688105.21
348603-48603100.908105.37
446926-4692697.426101.77
548277-48277100.231104.76
648435-48435100.559105.01
45min144991-4499193.40995.802.3298.69101.322.32
247732-4773299.100104.74
346320-4632096.168101.75
445047-4504793.52598.95
546893-4689397.358103.00
645879-4587995.253100.82
极限144862-4486293.14195.962.4599.46102.552.44
247810-4781099.262106.01
346880-4688097.331103.99
444987-4498793.40199.87
546475-4647596.490103.21
646304-4630496.135102.76
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4000
标示量(mg)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%
113.818100780914810778100380729809460.17
213.898088880920809040.03
单位质量响应值RSD%判断
5861.405824.620.45数据可信
供试品溶液-2021561批-氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min174399-7439982.54388.544.2382.5488.544.23
281362-8136290.26890.27
376952-7695285.37585.37
481573-8157390.50290.50
583186-8318692.29192.29
681360-8136090.26590.27
10min183675-8367592.83494.682.1093.7595.662.10
286869-8686996.37797.38
385689-8568995.06896.02
482605-8260591.64792.65
586348-8634895.79996.82
686863-8686396.37197.37
15min183382-8338292.50994.751.5494.4696.791.56
286299-8629995.74597.82
385278-8527894.61296.62
484400-8440093.63895.66
586826-8682696.33098.42
686246-8624695.68697.76
20min183358-8335892.48293.921.4395.4697.001.43
286074-8607495.49598.63
385010-8501094.31597.37
483040-8304092.12995.19
584908-8490894.20297.36
685516-8551694.87698.01
30min183176-8317692.28093.561.1996.2897.691.20
284059-8405993.26097.46
383904-8390493.08897.19
484112-8411293.31997.41
584557-8455793.81298.02
686154-8615495.58499.78
45min180379-8037989.17789.991.3994.2195.161.39
282643-8264391.68996.92
380264-8026489.04994.19
479794-7979488.52893.65
581994-8199490.96996.22
681583-8158390.51395.77
极限180804-8080489.64990.441.3395.6796.611.32
283120-8312092.21898.47
380958-8095889.81995.95
480228-8022889.01095.12
581611-8161190.54496.80
682378-8237891.39597.65
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