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%
117.819430419427309426139429419441669430980.07
217.849413609421239417420.06
单位质量响应值RSD%判断
52953.2852788.230.23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%
5min11035936-103593699.21298.221.7499.2198.221.74
21022454-102245497.92197.92
31027947-102794798.44798.45
41052993-1052993100.846100.85
51010400-101040096.76796.77
61003853-100385396.14096.14
10min11069697-1069697102.446101.611.46102.61101.771.46
21058294-1058294101.354101.52
31067972-1067972102.280102.44
41081706-1081706103.596103.76
51049315-1049315100.494100.65
61038687-103868799.47699.64
15min11080083-1080083103.440102.501.47103.78102.841.47
21065098-1065098102.005102.34
31077813-1077813103.223103.56
41091007-1091007104.487104.83
51059683-1059683101.487101.82
61047920-1047920100.360100.69
20min11080978-1080978103.526102.641.35104.03103.151.35
21068576-1068576102.338102.84
31078529-1078529103.292103.80
41090633-1090633104.451104.97
51060576-1060576101.572102.07
61051198-1051198100.674101.17
30min11083443-1083443103.762102.821.36104.44103.501.36
21072844-1072844102.747103.42
31079747-1079747103.408104.09
41091633-1091633104.547105.24
51062028-1062028101.711102.38
61052178-1052178100.768101.43
45min11083447-1083447103.763102.721.36104.62103.561.36
21067639-1067639102.249103.09
31081276-1081276103.555104.41
41089178-1089178104.311105.17
51062502-1062502101.757102.59
61051213-1051213100.675101.50
极限11080446-1080446103.475102.581.57104.50103.591.57
21065332-1065332102.028103.04
31077327-1077327103.176104.20
41095785-1095785104.944105.98
51058229-1058229101.347102.35
61049221-1049221100.485101.48
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%
117.819462519449679454299465189447289455790.09
217.849428179443539435850.12
单位质量响应值RSD%判断
53092.5952891.540.27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%
5min1513949-51394949.10950.404.5749.1150.404.56
2530559-53055950.69650.70
3523995-52399550.06950.07
4503898-50389848.14848.15
5572975-57297554.74954.75
6519572-51957249.64649.65
10min1522271-52227149.90451.612.8049.9951.702.80
2554820-55482053.01453.10
3539103-53910351.51251.60
4536954-53695451.30751.39
5560769-56076953.58253.67
6527041-52704150.36050.44
15min1520065-52006549.69351.213.2549.8651.383.25
2547987-54798752.36152.53
3537127-53712751.32351.49
4527728-52772850.42550.59
5563549-56354953.84854.03
6519012-51901249.59249.76
20min1520792-52079249.76350.813.0250.0151.073.02
2541377-54137751.72951.99
3535892-53589251.20551.46
4523240-52324049.99650.25
5556634-55663453.18753.46
6512704-51270448.99049.24
30min1513889-51388949.10349.753.4549.4350.093.45
2528373-52837350.48750.83
3525865-52586550.24750.59
4510762-51076248.80449.14
5548598-54859852.41952.78
6496233-49623347.41647.75
45min1502837-50283748.04748.443.1548.4648.873.15
2508268-50826848.56649.00
3505851-50585148.33548.76
4500405-50040547.81548.23
5536320-53632051.24651.69
6488250-48825046.65347.06
极限1471474-47147445.05045.532.3945.5446.032.40
2478469-47846945.71846.23
3481237-48123745.98346.49
4470822-47082244.98845.48
5495119-49511947.30947.84
6461804-46180444.12644.61
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