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%
117.412399442402552405972406022403682403530.12
217.402410932410612410770.01
单位质量响应值RSD%判断
13805.4613855.000.26数据可信
供试品溶液-2023052711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%
5min1265599-26559997.24098.121.8897.2498.121.88
2267792-26779298.04398.04
3270950-27095099.19999.20
4275973-275973101.038101.04
5261182-26118295.62395.62
6266544-26654497.58697.59
10min1276890-276890101.37499.541.93101.5499.701.93
2270579-27057999.06399.23
3274400-274400100.462100.63
4276264-276264101.145101.31
5262822-26282296.22496.38
6270280-27028098.95499.12
15min1265931-26593197.362100.532.4797.69100.862.46
2275302-275302100.793101.12
3274717-274717100.578100.91
4275407-275407100.831101.17
5286115-286115104.751105.07
6270086-27008698.88399.21
20min1266558-26655897.59199.641.5398.08100.141.53
2269252-26925298.57899.07
3274169-274169100.378100.88
4276884-276884101.372101.88
5276047-276047101.065101.56
6269985-26998598.84699.34
30min1266350-26635097.51598.411.8098.1799.071.79
2268977-26897798.47799.14
3271833-27183399.523100.19
4275425-275425100.838101.51
5261259-26125995.65196.31
6268911-26891198.45399.11
45min1265544-26554497.22098.301.7798.0499.131.76
2268419-26841998.27399.10
3271840-27184099.525100.36
4274854-274854100.629101.47
5261332-26133295.67896.50
6269029-26902998.49699.32
极限1264313-26431396.76997.901.8697.7598.901.86
2267117-26711797.79698.78
3271821-27182199.518100.52
4273398-273398100.096101.11
5259779-25977995.10996.09
6268040-26804098.13499.12
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%
117.412416672411212409982406802406072410150.18
217.402401042400682400860.02
单位质量响应值RSD%判断
13843.4813798.050.24数据可信
供试品溶液-2023052811批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1122465-12246544.86744.681.3044.8744.681.30
2121926-12192644.67044.67
3123192-12319245.13445.13
4119484-11948443.77543.78
5123811-12381145.36045.36
6120853-12085344.27744.28
10min1126181-12618146.22947.031.8046.3047.101.80
2130189-13018947.69747.77
3130955-13095547.97848.05
4126145-12614546.21546.29
5130232-13023247.71347.79
6126510-12651046.34946.42
15min1130505-13050547.81348.651.7947.9648.801.79
2135453-13545349.62649.78
3133504-13350448.91149.07
4130367-13036747.76247.91
5135492-13549249.64049.79
6131369-13136948.12948.28
20min1133888-13388849.05249.761.6249.2850.001.62
2138031-13803150.57050.81
3136426-13642649.98250.22
4134241-13424149.18149.41
5138671-13867150.80551.04
6133679-13367948.97649.21
30min1140894-14089451.61951.691.8451.9352.011.84
2143547-14354752.59152.91
3141487-14148751.83652.16
4138919-13891950.89551.21
5144224-14422452.83953.16
6137503-13750350.37750.69
45min1145863-14586353.43953.662.1353.8454.062.13
2148561-14856154.42854.84
3147429-14742954.01354.42
4144400-14440052.90353.30
5150639-15063955.18955.60
6141872-14187251.97752.37
极限1161029-16102958.99659.631.3959.4860.121.39
2164624-16462460.31360.81
3162189-16218959.42159.92
4162824-16282459.65360.14
5165991-16599160.81461.32
6159878-15987858.57459.06
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