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500
标示量(mg)25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%
117.319430419427309426139429419441669430980.07
217.329413609421239417420.06
单位质量响应值RSD%判断
54482.8454373.090.15数据可信
影响因素30天-供试品溶液-2024051911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%
5min11041020-104102096.84795.901.7096.8595.901.70
21027986-102798695.63495.63
31033148-103314896.11496.11
41057874-105787498.41598.41
51015567-101556794.47994.48
61009629-100962993.92693.93
10min11074559-107455999.96799.161.46100.1399.321.46
21063885-106388598.97499.13
31071826-107182699.71399.87
41087509-1087509101.172101.34
51053214-105321497.98198.14
61044395-104439597.16197.32
15min11084970-1084970100.935100.041.46101.26100.361.46
21070955-107095599.63299.96
31082794-1082794100.733101.06
41095958-1095958101.958102.29
51064605-106460599.04199.36
61052749-105274997.93898.26
20min11086968-1086968101.121100.231.34101.62100.721.35
21074127-107412799.927100.42
31083584-1083584100.806101.30
41096269-1096269101.987102.49
51066624-106662499.22999.71
61056762-105676298.31198.79
30min11088622-1088622101.275100.391.36101.94101.051.36
21078582-1078582100.341101.00
31084978-1084978100.936101.60
41097469-1097469102.098102.77
51067702-106770299.32999.98
61057301-105730198.36199.01
45min11089287-1089287101.337100.311.37102.17101.131.37
21072857-107285799.809100.63
31087192-1087192101.142101.97
41095124-1095124101.880102.72
51068395-106839599.393100.21
61056498-105649898.28799.10
极限11086399-1086399101.068100.191.58102.07101.191.57
21071207-107120799.655100.65
31083323-1083323100.782101.78
41101865-1101865102.507103.52
51064129-106412998.99799.98
61055000-105500098.14799.12
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500
标示量(mg)25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%
117.319462519449679454299465189447289455790.09
217.329428179443539435850.12
单位质量响应值RSD%判断
54626.1754479.500.20数据可信
影响因素30天-供试品溶液-2024051911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%
5min1513949-51394947.70448.964.5647.7048.964.56
2530559-53055949.24549.25
3523995-52399548.63648.64
4503898-50389846.77146.77
5572975-57297553.18253.18
6519572-51957248.22548.23
10min1522271-52227148.47650.142.8048.5650.222.80
2554820-55482051.49751.58
3539103-53910350.03850.12
4536954-53695449.83949.92
5560769-56076952.04952.14
6527041-52704148.91949.00
15min1520065-52006548.27149.743.2548.4349.913.25
2547987-54798750.86351.03
3537127-53712749.85550.02
4527728-52772848.98349.14
5563549-56354952.30752.48
6519012-51901248.17448.34
20min1520792-52079248.33949.363.0248.5849.613.02
2541377-54137750.24950.50
3535892-53589249.74049.99
4523240-52324048.56648.81
5556634-55663451.66551.93
6512704-51270447.58847.83
30min1513889-51388947.69848.323.4548.0248.653.45
2528373-52837349.04249.38
3525865-52586548.81049.14
4510762-51076247.40847.73
5548598-54859850.92051.27
6496233-49623346.05946.38
45min1502837-50283746.67247.063.1547.0747.473.15
2508268-50826847.17647.59
3505851-50585146.95247.36
4500405-50040546.44646.85
5536320-53632049.78050.21
6488250-48825045.31845.72
极限1471474-47147443.76144.232.3944.2444.722.40
2478469-47846944.41044.91
3481237-48123744.66745.16
4470822-47082243.70144.18
5495119-49511945.95646.47
6461804-46180442.86443.34
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