枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.41 2415642415472409492408132409332411610.16
217.402402382403642403010.04
单位质量响应值RSD%判断
13851.8713810.400.22数据可信
长期30℃12月-供试品溶液-2023052611批-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%
5min1264079-26407996.67798.302.7996.6898.302.79
2265022-26502297.02397.02
3282688-282688103.490103.49
4270806-27080699.14099.14
5265716-26571697.27797.28
6262750-26275096.19196.19
10min1268980-26898098.47298.931.3298.6399.091.32
2266991-26699197.74397.91
3271311-27131199.32599.50
4276720-276720101.305101.47
5269964-26996498.83298.99
6267388-26738897.88998.05
15min1266912-26691297.71498.601.4498.0498.921.44
2265857-26585797.32897.65
3270323-27032398.96399.30
4276162-276162101.101101.43
5270229-27022998.92999.26
6266442-26644297.54297.87
20min1267357-26735797.87798.421.3198.3798.911.31
2265828-26582897.31897.80
3270215-27021598.92499.43
4275179-275179100.741101.24
5268416-26841698.26598.76
6266019-26601997.38897.87
30min1265798-26579897.30798.341.4697.9699.001.46
2265319-26531997.13197.78
3269765-26976598.75999.43
4275843-275843100.984101.65
5268449-26844998.27798.93
6266562-26656297.58698.23
45min1265852-26585297.32698.011.5698.1498.841.56
2264165-26416596.70997.52
3267419-26741997.90098.73
4275604-275604100.897101.74
5268398-26839898.25899.08
6264932-26493296.99097.80
极限1265390-26539097.15797.761.3398.1398.741.32
2264013-26401396.65397.63
3267924-26792498.08599.08
4273638-273638100.177101.18
5266658-26665897.62198.60
6264625-26462596.87797.85
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.41 2406622403302405062405562402522404610.07
217.402392142388082390110.13
单位质量响应值RSD%判断
13811.6613736.260.39数据可信
长期30℃12月-供试品溶液-2023052811批-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%
5min1266925-26692598.12596.991.9498.1397.001.94
2263552-26355296.88596.89
3264161-26416197.10997.11
4268070-26807098.54698.55
5266303-26630397.89797.90
6254033-25403393.38693.39
10min1271839-27183999.93298.082.16100.1098.242.16
2267016-26701698.15998.32
3267967-26796798.50898.67
4267758-26775898.43298.60
5270546-27054699.45699.62
6255692-25569293.99694.15
15min1272604-272604100.21398.351.92100.5498.671.92
2267625-26762598.38398.71
3267864-26786498.47098.80
4267731-26773198.42298.75
5271336-27133699.747100.08
6257978-25797894.83695.15
20min1272189-272189100.06098.152.07100.5698.642.07
2267384-26738498.29498.78
3267602-26760298.37498.86
4266729-26672998.05398.55
5271339-27133999.748100.24
6256708-25670894.36994.84
30min1268105-26810598.55997.851.9199.2298.501.91
2266940-26694098.13198.78
3267430-26743098.31198.97
4265941-26594197.76498.42
5271975-27197599.982100.64
6256709-25670994.37095.00
45min1286436-286436105.29899.093.42106.1399.913.41
2266973-26697398.14398.96
3267206-26720698.22999.05
4266733-26673398.05598.87
5271180-27118099.690100.52
6258753-25875395.12195.91
极限1276458-276458101.63098.042.26102.6399.022.26
2266645-26664598.02299.00
3264523-26452397.24298.22
4264533-26453397.24698.23
5269568-26956899.097100.09
6258425-25842595.00195.94
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