坎地沙坦酯左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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8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%
116.084216842437421644227442246422580.27
216.124247442684425790.35
单位质量响应值RSD%判断
2627.992641.380.36数据可信
供试品溶液-2024042711批-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%
5min147110-47110100.379100.300.64100.38100.300.64
246886-4688699.90199.90
346824-4682499.76999.77
447595-47595101.412101.41
547187-47187100.543100.54
646833-4683399.78899.79
10min147995-47995102.264100.321.47103.38101.431.45
246758-4675899.629100.74
347475-47475101.156102.26
447440-47440101.082102.21
546060-4606098.14199.26
646759-4675999.631100.74
15min147185-47185100.53899.321.58102.79101.551.56
246664-4666499.428101.65
346763-4676399.639101.87
447248-47248100.673102.92
545225-4522596.36298.57
646607-4660799.307101.52
20min146877-4687799.88298.051.58103.25101.381.56
245730-4573097.438100.76
346054-4605498.129101.47
446630-4663099.356102.72
544823-4482395.50698.78
645991-4599197.994101.31
30min146435-4643598.94096.701.84103.42101.121.80
245180-4518096.266100.67
345918-4591897.839102.27
445465-4546596.874101.35
543966-4396693.68098.02
645331-4533196.588101.00
45min145689-4568997.35195.142.41102.93100.642.34
244627-4462795.088100.56
343664-4366493.03698.55
446114-4611498.256103.81
543420-4342092.51697.90
644395-4439594.594100.07
60min144693-4469395.22994.091.40101.89100.641.40
243959-4395993.665100.20
343958-4395893.662100.21
444836-4483695.533102.17
543141-4314191.92298.33
644360-4436094.519101.05
极限144144-4414494.05992.591.63101.78100.191.61
242826-4282691.25198.82
343811-4381193.349100.94
444218-4421894.216101.92
542531-4253190.62298.05
643192-4319292.03099.61
坎地沙坦酯左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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8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%
116.084268442720426854272642673426980.06
216.124277342725427490.08
单位质量响应值RSD%判断
2655.352651.920.10数据可信
供试品溶液-2024042711批-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%
5min143421-4342191.85789.786.5091.8689.786.50
241442-4144287.67087.67
344249-4424993.60993.61
441856-4185688.54688.55
537849-3784980.06980.07
645813-4581396.91796.92
10min145230-4523095.68498.752.2396.7099.752.21
247888-47888101.307102.28
346183-4618397.70098.74
447732-47732100.977101.96
546055-4605597.42998.32
647001-4700199.430100.51
15min146754-4675498.90899.071.41100.99101.161.33
247084-4708499.606101.71
346010-4601097.33499.46
447201-4720199.853101.96
547758-47758101.032103.00
646175-4617597.68399.86
20min145752-4575296.78897.681.4199.97100.881.34
246929-4692999.278102.48
345694-4569496.66599.87
446687-4668798.766101.98
546622-4662298.629101.72
645367-4536795.97499.24
30min145767-4576796.82097.932.23101.08102.222.15
248014-48014101.573105.88
345378-4537895.997100.28
447093-4709399.625103.94
545807-4580796.904101.10
645703-4570396.684101.02
45min145046-4504695.29595.511.78100.63100.881.71
246322-4632297.994103.43
343988-4398893.05698.40
445576-4557696.416101.84
545336-4533695.908101.18
644631-4463194.41799.82
60min144425-4442593.98194.611.89100.37101.041.80
245290-4529095.811102.34
343946-4394692.96899.35
445872-4587297.042103.53
545108-4510895.426101.76
643684-4368492.41398.87
极限144256-4425693.62392.201.43101.0699.681.34
243348-4334891.70299.29
343273-4327391.54498.96
444417-4441793.964101.53
543389-4338991.78999.18
642822-4282290.59098.07
坎地沙坦酯左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100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8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%
116.084291042896428374255942704427810.35
216.124278742659427230.22
单位质量响应值RSD%判断
2660.512650.310.28数据可信
供试品溶液-2024042711批-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%
5min140604-4060485.84095.665.1085.8495.665.10
245436-4543696.05696.06
346276-4627697.83297.83
446311-4631197.90697.91
546312-4631297.90897.91
646541-4654198.39298.39
10min143962-4396292.94097.912.7093.8998.982.72
247128-4712899.633100.70
347177-4717799.736100.82
446632-4663298.58499.67
547084-4708499.540100.63
645906-4590697.04998.14
15min144561-4456194.20697.711.7896.1999.861.82
246441-4644198.180100.35
346767-4676798.870101.06
446595-4659598.506100.69
546422-4642298.140100.33
646526-4652698.360100.53
20min144506-4450694.09095.641.7297.1298.871.72
245526-4552696.24699.51
346657-4665798.637101.93
444854-4485494.82598.10
545093-4509395.33198.61
644795-4479594.70197.97
30min143949-4394992.91295.241.2996.9999.541.33
245595-4559596.392100.73
345309-4530995.787100.18
445253-4525395.669100.00
544951-4495195.03099.37
645246-4524695.65499.97
45min143689-4368992.36293.910.9497.4799.271.00
244521-4452194.12199.53
344818-4481894.749100.20
444701-4470194.50299.90
544199-4419993.44198.84
644604-4460494.29799.68
60min143259-4325991.45392.871.0797.5999.271.11
244209-4420993.46299.91
344518-4451894.115100.62
444121-4412193.27699.72
543979-4397992.97599.41
643502-4350291.96798.39
极限142428-4242889.69791.691.6496.8599.121.63
243700-4370092.38699.88
344515-4451594.109101.66
442979-4297990.86198.34
543158-4315891.24098.71
643437-4343791.83099.28
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