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%
116.261762931762381764771764761763171763600.07
216.281790441791921791180.06
单位质量响应值RSD%判断
10846.2511002.331.02数据可信
供试品溶液-24112801批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138554-3855419.81319.837.3919.8119.837.39
237813-3781319.43219.43
340156-4015620.63620.64
434288-3428817.62117.62
542884-4288422.03822.04
637825-3782519.43819.44
10min184051-8405143.19443.314.7143.4143.544.71
288558-8855845.51045.73
384719-8471943.53743.77
477720-7772039.94140.14
588044-8804445.24645.49
682622-8262242.46042.68
15min1101497-10149752.16056.435.0952.8657.135.07
2115024-11502459.11159.83
3113090-11309058.11758.83
4104202-10420253.55054.19
5113761-11376158.46259.21
6111254-11125457.17457.86
20min1130739-13073967.18766.683.0668.4768.013.07
2135914-13591469.84771.23
3129362-12936266.48067.84
4124950-12495064.21265.45
5131465-13146567.56068.96
6126073-12607364.78966.11
30min1151377-15137777.79378.272.7279.8280.342.73
2158619-15861981.51583.67
3150014-15001477.09379.19
4146964-14696475.52577.47
5155451-15545179.88782.03
6151411-15141177.81179.85
45min1165239-16523984.91785.542.9487.8188.482.94
2175261-17526190.06793.13
3163971-16397184.26587.22
4160682-16068282.57585.36
5167417-16741786.03689.07
6166199-16619985.41088.32
60min1169502-16950287.10888.401.9190.9492.291.93
2178000-17800091.47595.54
3172309-17230988.55092.44
4169073-16907386.88790.59
5170524-17052487.63391.62
6172715-17271588.75992.62
极限1171803-17180388.29089.591.0793.0994.461.07
2177051-17705190.98796.06
3173226-17322689.02293.90
4175571-17557190.22794.90
5173668-17366889.24994.21
6174690-17469089.77494.62
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%
116.261789881771911770571770211768541774220.50
216.281798031806281802160.33
单位质量响应值RSD%判断
10911.5611069.781.02数据可信
供试品溶液-1批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138506-3850619.66917.955.9019.6717.955.89
233634-3363417.18017.18
332843-3284316.77616.78
434434-3443417.58917.59
534879-3487917.81617.82
636554-3655418.67218.67
10min182899-8289942.34540.742.2642.5640.942.27
278803-7880340.25340.44
377685-7768539.68239.87
479226-7922640.46940.66
579390-7939040.55240.75
680547-8054741.14341.35
15min1107019-10701954.66554.163.8255.3554.813.77
2107011-10701154.66155.30
3105173-10517353.72254.35
4109597-10959755.98256.63
5108937-10893755.64556.29
698414-9841450.27050.93
20min1130089-13008966.45065.802.4167.7567.062.38
2126688-12668864.71265.96
3126586-12658664.66065.88
4125980-12598064.35165.62
5134137-13413768.51769.78
6129479-12947966.13867.36
30min1148249-14824975.72676.500.9677.7678.490.94
2150228-15022876.73778.70
3148070-14807075.63477.58
4149477-14947776.35378.34
5150970-15097077.11679.14
6151601-15160177.43879.40
45min1167895-16789585.76185.081.9288.6487.921.89
2166755-16675585.17988.00
3165870-16587084.72687.51
4162683-16268383.09985.93
5171913-17191387.81390.70
6164314-16431483.93286.75
60min1171534-17153487.62087.451.1091.4591.231.08
2169380-16938086.51990.28
3171199-17119987.44991.17
4168771-16877186.20889.96
5173618-17361888.68492.54
6172721-17272188.22691.98
极限1174505-17450589.13788.071.0893.9492.821.08
2170471-17047187.07791.80
3170740-17074087.21491.91
4171504-17150487.60492.32
5174721-17472189.24894.09
6172510-17251088.11892.85
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%
116.261791661769231770441770381770331774410.55
216.281788991793701791340.19
单位质量响应值RSD%判断
10912.7311003.320.59数据可信
供试品溶液-2批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138747-3874719.85020.576.0819.8520.576.08
239806-3980620.39320.39
338509-3850919.72819.73
444701-4470122.90122.90
540932-4093220.97020.97
638238-3823819.59019.59
10min181366-8136641.68442.753.1941.9042.983.20
283434-8343442.74442.97
381843-8184341.92942.15
488620-8862045.40045.65
583234-8323442.64142.87
682170-8217042.09642.31
15min1111539-11153957.14258.202.1657.8358.902.13
2113705-11370558.25258.95
3112122-11212257.44158.13
4114610-11461058.71559.47
5111721-11172157.23557.94
6117952-11795260.42761.11
20min1130390-13039066.79966.480.6368.1267.830.63
2130405-13040566.80768.16
3129794-12979466.49467.82
4130454-13045466.83268.24
5128940-12894066.05767.40
6128598-12859865.88167.24
30min1150946-15094677.33077.680.8279.3979.770.78
2152878-15287878.32080.41
3152131-15213177.93780.00
4149862-14986276.77578.93
5150963-15096377.33979.42
6152980-15298078.37280.46
45min1162952-16295283.48185.101.5186.4088.061.47
2169685-16968586.93089.89
3164467-16446784.25787.19
4165663-16566384.87087.88
5165538-16553884.80687.74
6168387-16838786.26589.23
60min1166846-16684685.47685.263.5889.3289.163.42
2170365-17036587.27991.21
3170141-17014187.16491.03
4160067-16006782.00385.95
5158279-15827981.08784.97
6172825-17282588.53992.46
极限1168325-16832586.23486.181.0191.0391.030.96
2166468-16646885.28290.18
3169925-16992587.05391.89
4166539-16653985.31990.18
5167633-16763385.87990.66
6170456-17045687.32592.23
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