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%
112.012334602330422330782330232332382331680.08
212.012333562332912333240.02
单位质量响应值RSD%判断
19414.4919427.480.05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%
5min1145873-14587353.91848.116.8853.9248.116.88
2132065-13206548.81448.81
3119582-11958244.20044.20
4130521-13052148.24348.24
5124213-12421345.91245.91
6128692-12869247.56747.57
10min1261379-26137996.61195.012.0996.7095.092.09
2251498-25149892.95993.04
3254515-25451594.07494.15
4259464-25946495.90395.98
5251363-25136392.90992.99
6264116-26411697.62397.70
15min1273387-273387101.050100.301.11101.30100.531.11
2267476-26747698.86599.10
3275748-275748101.922102.15
4269038-26903899.44299.68
5270414-27041499.951100.18
6272033-272033100.549100.79
20min1273818-273818101.209100.431.25101.63100.831.25
2267412-26741298.84199.24
3276956-276956102.369102.77
4269107-26910799.46899.87
5271080-271080100.197100.59
6271882-271882100.493100.90
30min1273442-273442101.070100.331.29101.66100.901.29
2267047-26704798.70699.27
3276952-276952102.367102.94
4268936-26893699.40499.98
5270504-27050499.984100.55
6271737-271737100.440101.02
45min1273156-273156100.964100.261.31101.72101.001.30
2266998-26699898.68899.42
3276911-276911102.352103.09
4268613-26861399.285100.02
5270052-27005299.817100.55
6271740-271740100.441101.19
60min1272666-272666100.783100.091.23101.71101.001.22
2266961-26696198.67499.57
3276136-276136102.066102.98
4268158-26815899.117100.02
5269788-26978899.719100.62
6270964-270964100.154101.07
极限1272503-272503100.723100.051.23101.82101.131.23
2267034-26703498.70199.76
3276232-276232102.101103.18
4268171-26817199.122100.19
5269427-26942799.586100.65
6270791-270791100.090101.17
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%
112.012342782341082343222340732343072342180.06
212.012356382359492357940.10
单位质量响应值RSD%判断
19501.9219633.140.48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%
5min1126958-12695846.57546.5813.4746.5846.5813.47
2145955-14595553.54553.54
3117347-11734743.05043.05
4102532-10253237.61537.61
5146740-14674053.83353.83
6122359-12235944.88844.89
10min1259583-25958395.23092.753.9895.3192.833.98
2266729-26672997.85197.94
3242234-24223488.86588.94
4242263-24226388.87688.94
5257619-25761994.50994.60
6248519-24851991.17191.25
15min1267510-26751098.13899.510.7798.3799.740.77
2272283-27228399.889100.14
3271618-27161899.64599.86
4272898-272898100.114100.33
5270263-27026399.14899.40
6272961-272961100.138100.36
20min1267762-26776298.23099.710.8298.63100.100.81
2272664-272664100.029100.45
3272086-27208699.817100.20
4273748-273748100.426100.80
5270974-27097499.40999.82
6273501-273501100.336100.73
30min1267704-26770498.20999.590.7998.77100.150.78
2272272-27227299.885100.47
3271659-27165999.660100.21
4273466-273466100.323100.87
5270498-27049899.23499.81
6273158-273158100.210100.77
45min1267228-26722898.03499.500.8398.76100.230.83
2271995-27199599.783100.54
3271082-27108299.448100.17
4273148-273148100.206100.92
5270521-27052199.24299.99
6273333-273333100.274101.00
60min1266319-26631997.70199.430.9598.59100.330.95
2272076-27207699.813100.73
3271143-27114399.471100.35
4272766-272766100.066100.95
5270395-27039599.196100.11
6273561-273561100.358101.25
极限1266472-26647297.75799.180.8598.81100.250.84
2271724-27172499.684100.77
3270381-27038199.191100.24
4272294-27229499.893100.94
5269066-26906698.70999.78
6272245-27224599.875100.94
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%
112.012343242347532342902345352343572344520.09
212.012351752351552351650.01
单位质量响应值RSD%判断
19521.4019580.770.22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%
5min1127137-12713746.68050.6210.9846.6850.6210.98
2152009-15200955.81255.81
3150160-15016055.13355.13
4113435-11343541.64941.65
5146956-14695653.95753.96
6137594-13759450.51950.52
10min1264686-26468697.18396.163.3697.2696.243.36
2262769-26276996.47996.57
3273447-273447100.399100.49
4264303-26430397.04297.11
5246609-24660990.54590.64
6259594-25959495.31395.40
15min1270997-27099799.500100.270.9599.74100.510.95
2270790-27079099.42499.68
3276586-276586101.552101.81
4275195-275195101.041101.27
5270679-27067999.38399.62
6274293-274293100.710100.95
20min1271713-27171399.763100.480.83100.17100.890.83
2271427-27142799.658100.08
3276480-276480101.513101.94
4275456-275456101.137101.54
5271753-27175399.777100.18
6275108-275108101.009101.42
30min1272118-27211899.911100.470.84100.48101.050.84
2271005-27100599.503100.09
3276581-276581101.550102.15
4275549-275549101.171101.74
5271804-27180499.796100.37
6274765-274765100.883101.46
45min1270922-27092299.472100.280.96100.21101.030.96
2270642-27064299.369100.12
3276109-276109101.377102.14
4274945-274945100.949101.69
5270742-27074299.406100.15
6275439-275439101.131101.88
60min1270427-27042799.291100.030.86100.19100.940.86
2270130-27013099.181100.10
3275554-275554101.173102.11
4274260-274260100.698101.60
5270623-27062399.363100.27
6273622-273622100.464101.38
极限1269984-26998499.12899.750.82100.20100.830.82
2269331-26933198.88899.97
3274254-274254100.696101.80
4273649-273649100.474101.55
5269721-26972199.031100.10
6273091-273091100.269101.35
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