坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.012236412240332239212243432228432237560.26
212.012271742259452265600.39
单位质量响应值RSD%判断
18630.8118864.280.89数据可信
中间条件12月--供试品溶液-2023021121批-氢氯噻嗪-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%
5min1122457-12245746.89044.9315.1846.8944.9315.19
2133265-13326551.02951.03
3122267-12226746.81846.82
482144-8214431.45431.45
5122613-12261346.95046.95
6121257-12125746.43146.43
10min1243393-24339393.19889.219.4593.2889.299.46
2242389-24238992.81492.90
3243080-24308093.07893.16
4188341-18834172.11872.17
5243718-24371893.32393.40
6236962-23696290.73690.81
15min1257209-25720998.48999.230.8498.7299.450.83
2257480-25748098.59298.83
3262046-262046100.341100.57
4259723-25972399.45199.62
5261228-261228100.028100.26
6257225-25722598.49598.72
20min1257835-25783598.72899.610.9399.13100.000.91
2258002-25800298.79299.20
3262211-262211100.404100.80
4262968-262968100.694101.03
5261681-261681100.201100.60
6258116-25811698.83699.23
30min1257209-25720998.48999.501.3099.05100.051.28
2256709-25670998.29798.87
3262553-262553100.535101.10
4264895-264895101.432101.94
5260489-26048999.745100.31
6257214-25721498.49199.05
45min1256718-25671898.30199.511.3099.03100.231.28
2257094-25709498.44599.18
3263012-263012100.711101.45
4264229-264229101.177101.85
5261229-261229100.028100.76
6256948-25694898.38999.11
60min1256012-25601298.03099.281.1698.92100.161.14
2256329-25632998.15299.05
3261133-26113399.991100.89
4263791-263791101.009101.85
5260129-26012999.607100.51
6258183-25818398.86299.75
极限1256093-25609398.06199.161.1899.11100.211.16
2256797-25679798.33199.39
3261074-26107499.969101.04
4263647-263647100.954101.97
5259675-25967599.433100.50
6256458-25645898.20199.25
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.012225542236882236152240222231882234130.26
212.012228982243302236140.46
单位质量响应值RSD%判断
18602.2518618.980.07数据可信
中间条件12月--供试品溶液-2023021221批-氢氯噻嗪-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%
5min1135503-13550352.26639.0825.3252.2739.0825.32
2130812-13081250.45650.46
387014-8701433.56333.56
494550-9455036.46936.47
573269-7326928.26128.26
686739-8673933.45733.46
10min1240429-24042992.73787.138.7092.8287.208.71
2251607-25160797.04997.13
3207159-20715979.90479.96
4233182-23318289.94290.00
5200633-20063377.38777.43
6222408-22240885.78685.84
15min1257424-25742499.292100.380.8399.53100.590.83
2263156-263156101.503101.75
3261147-261147100.728100.92
4261572-261572100.892101.10
5258364-25836499.65599.83
6259753-259753100.191100.39
20min1258130-25813099.565100.880.8299.97101.250.81
2263588-263588101.670102.08
3263786-263786101.746102.10
4262158-262158101.118101.50
5260951-260951100.653100.99
6260560-260560100.502100.87
30min1258036-25803699.528100.910.90100.10101.450.90
2264270-264270101.933102.52
3263823-263823101.761102.29
4262347-262347101.191101.74
5260536-260536100.493101.00
6260634-260634100.531101.06
45min1257168-25716899.194100.640.9299.93101.350.91
2263088-263088101.477102.23
3263599-263599101.674102.37
4261688-261688100.937101.65
5259935-259935100.261100.94
6259994-259994100.284100.98
60min1256827-25682799.062100.410.9199.97101.290.90
2262358-262358101.196102.12
3263128-263128101.493102.36
4261184-261184100.743101.63
5259498-259498100.092100.94
6258902-25890299.862100.73
极限1255592-25559298.586100.210.9599.66101.260.94
2262381-262381101.204102.30
3262011-262011101.062102.10
4260248-260248100.382101.43
5259062-25906299.924100.94
6259576-259576100.122101.16
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数2000
标示量(mg)6.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.012265852260782260702257082263902261660.15
212.012228972228522228740.02
单位质量响应值RSD%判断
18831.4718557.371.04数据可信
中间条件12月--供试品溶液-2023021321批-氢氯噻嗪-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%
5min1123564-12356447.44952.085.9547.4552.085.95
2147738-14773856.73256.73
3137996-13799652.99152.99
4131491-13149150.49350.49
5134410-13441051.61451.61
6138552-13855253.20553.20
10min1248649-24864995.48398.212.5495.5698.302.54
2265994-265994102.144102.24
3255716-25571698.19798.29
4259046-25904699.47599.56
5249108-24910895.65995.75
6255946-25594698.28598.37
15min1261829-261829100.544102.201.25100.78102.451.25
2269369-269369103.440103.70
3266371-266371102.288102.54
4270343-270343103.814104.06
5263384-263384101.141101.39
6265527-265527101.964102.22
20min1260474-260474100.024102.201.49100.43102.621.49
2269842-269842103.621104.06
3266658-266658102.398102.82
4271168-271168104.130104.55
5264040-264040101.393101.81
6264649-264649101.627102.05
30min1261507-261507100.420102.451.70100.99103.041.70
2268467-268467103.093103.70
3266370-266370102.288102.88
4274688-274688105.482106.08
5264048-264048101.396101.98
6265689-265689102.026102.62
45min1260142-26014299.896102.302.08100.64103.062.08
2268529-268529103.117103.90
3265834-265834102.082102.85
4276023-276023105.995106.77
5262424-262424100.773101.52
6265478-265478101.945102.71
60min1260137-26013799.894102.342.45100.80103.272.44
2268273-268273103.019103.97
3265366-265366101.902102.84
4278434-278434106.921107.87
5261810-261810100.537101.46
6264996-264996101.760102.69
极限1260023-26002399.851102.002.52100.92103.102.51
2268437-268437103.082104.21
3263756-263756101.284102.39
4277869-277869106.704107.83
5261042-261042100.242101.33
6262590-262590100.836101.94
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