枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.764643844646924665444649564677764656700.31
213.794654074629364641720.38
单位质量响应值RSD%判断
33842.3033660.040.39数据可信
影响因素30天-供试品溶液-2024041121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%
2min1284632-28463253.37764.8813.2853.3864.8813.28
2336393-33639363.08463.08
3404294-40429475.81775.82
4396492-39649274.35474.35
5330968-33096862.06762.07
6323123-32312360.59560.60
5min1483388-48338890.65095.054.0690.6595.054.06
2503110-50311094.34894.35
3530131-53013199.41699.42
4533076-53307699.96899.97
5501605-50160594.06694.07
6489725-48972591.83891.84
10min1531091-53109199.596100.961.0599.60100.961.04
2533168-53316899.98599.99
3544088-544088102.033102.03
4542354-542354101.708101.71
5543193-543193101.865101.87
6536142-536142100.543100.54
15min1539389-539389101.152101.980.61101.15101.980.61
2541336-541336101.517101.52
3545435-545435102.286102.29
4546413-546413102.469102.47
5547929-547929102.753102.75
6542476-542476101.731101.73
20min1540382-540382101.338102.020.60101.34102.020.60
2540541-540541101.368101.37
3547984-547984102.764102.76
4544103-544103102.036102.04
5547415-547415102.657102.66
6543801-543801101.979101.98
30min1544213-544213102.057102.540.61102.06102.540.60
2543367-543367101.898101.90
3549856-549856103.115103.11
4550847-550847103.301103.30
5548286-548286102.820102.82
6544069-544069102.029102.03
45min1541204-541204101.492102.530.85101.49102.540.85
2544159-544159102.046102.05
3552430-552430103.597103.60
4549445-549445103.038103.04
5550558-550558103.246103.25
6542713-542713101.775101.78
极限1542286-542286101.695102.310.47101.70102.310.46
2544697-544697102.147102.15
3549100-549100102.973102.97
4546211-546211102.431102.43
5547443-547443102.662102.66
6543591-543591101.940101.94
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.764664104701904659324671814662424671910.38
213.794679204668304673750.17
单位质量响应值RSD%判断
33952.8333892.310.13数据可信
影响因素30天-供试品溶液-2024041121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%
2min1364057-36405767.92665.2617.6367.9365.2617.63
2373073-37307369.60969.61
3304105-30410556.74056.74
4439814-43981482.06182.06
5260336-26033648.57448.57
6357175-35717566.64266.64
5min1513960-51396095.89692.675.3895.9092.675.38
2517142-51714296.48996.49
3498051-49805192.92792.93
4518570-51857096.75696.76
5450380-45038084.03384.03
6481822-48182289.89989.90
10min1537834-537834100.35098.641.54100.3598.641.54
2531080-53108099.09099.09
3528537-52853798.61598.62
4535856-53585699.98199.98
5516599-51659996.38896.39
6522240-52224097.44097.44
15min1544006-544006101.502101.232.11101.50101.232.11
2563233-563233105.089105.09
3529486-52948698.79298.79
4543537-543537101.414101.41
5537801-537801100.344100.34
6537381-537381100.265100.27
20min1541570-541570101.047101.811.60101.05101.811.60
2538851-538851100.540100.54
3562264-562264104.908104.91
4547617-547617102.175102.18
5543794-543794101.462101.46
6539806-539806100.718100.72
30min1541215-541215100.981100.900.76100.98100.900.76
2541122-541122100.963100.96
3535297-53529799.87799.88
4543630-543630101.431101.43
5546417-546417101.951101.95
6537122-537122100.217100.22
45min1543468-543468101.401101.360.78101.40101.360.78
2539948-539948100.744100.74
3536761-536761100.150100.15
4545318-545318101.746101.75
5548201-548201102.284102.28
6545723-545723101.822101.82
极限1544647-544647101.621101.350.74101.62101.350.74
2545483-545483101.777101.78
3536424-536424100.087100.09
4542150-542150101.155101.16
5548141-548141102.273102.27
6542235-542235101.171101.17
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.764660804676104673634670154639224663980.33
213.794692114698324695220.10
单位质量响应值RSD%判断
33895.2034048.010.32数据可信
影响因素30天-供试品溶液-2024041121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%
2min1196319-19631936.57740.126.3936.5840.126.39
2230630-23063042.96942.97
3226320-22632042.16642.17
4224521-22452141.83141.83
5204970-20497038.18938.19
6209152-20915238.96838.97
5min1264591-26459149.29754.488.2949.3054.488.29
2319711-31971159.56659.57
3302265-30226556.31656.32
4311725-31172558.07858.08
5294364-29436454.84454.84
6261742-26174248.76648.77
10min1290550-29055054.13357.278.4154.1357.278.41
2290843-29084354.18854.19
3322437-32243760.07460.07
4337584-33758462.89662.90
5329560-32956061.40161.40
6273446-27344650.94750.95
15min1306925-30692557.18457.894.1957.1857.894.19
2328844-32884461.26861.27
3299577-29957755.81555.82
4324858-32485860.52560.53
5298517-29851755.61855.62
6305459-30545956.91156.91
20min1282193-28219352.57657.068.8752.5857.068.87
2322768-32276860.13660.14
3316701-31670159.00659.01
4334754-33475462.36962.37
5317191-31719159.09759.10
6263922-26392249.17249.17
30min1316036-31603658.88257.733.1958.8857.733.19
2315854-31585458.84858.85
3297527-29752755.43355.43
4321600-32160059.91859.92
5309451-30945157.65557.65
6298777-29877755.66655.67
45min1286906-28690653.45456.633.3253.4556.633.32
2313171-31317158.34858.35
3298103-29810355.54155.54
4313018-31301858.31958.32
5307880-30788057.36257.36
6304692-30469256.76856.77
极限1282947-28294752.71754.756.0952.7254.756.08
2297995-29799555.52055.52
3273067-27306750.87650.88
4325755-32575560.69260.69
5292392-29239254.47654.48
6290886-29088654.19654.20
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