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%
117.319560239467539462799448339442869476350.51
217.329446849449169448000.02
单位质量响应值RSD%判断
54744.9554549.650.26数据可信
影响因素30天-供试品溶液-2024051911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%
5min11025858-102585895.05394.536.8295.0594.536.82
21081651-1081651100.223100.22
31035834-103583495.97895.98
4887554-88755482.23882.24
51019436-101943694.45894.46
61070709-107070999.20999.21
10min11063260-106326098.51999.621.6998.6899.771.69
21091522-1091522101.138101.30
31071231-107123199.25799.42
41056901-105690197.93098.07
51064688-106468898.65198.81
61102969-1102969102.198102.36
15min11074926-107492699.600100.571.5699.92100.891.57
21097823-1097823101.721102.06
31083296-1083296100.375100.70
41065146-106514698.69498.99
51079092-107909299.986100.31
61111927-1111927103.028103.36
20min11085649-1085649100.593101.101.42101.08101.601.43
21098989-1098989101.829102.33
31090149-1090149101.010101.50
41070424-107042499.18399.65
51085390-1085390100.569101.06
61116399-1116399103.443103.95
30min11090333-1090333101.027101.141.48101.68101.801.48
21098930-1098930101.824102.50
31073589-107358999.476100.14
41076399-107639999.736100.37
51092419-1092419101.221101.88
61117811-1117811103.573104.25
45min11089448-1089448100.945101.461.06101.77102.291.07
21095744-1095744101.529102.37
31091853-1091853101.168102.00
41082482-1082482100.300101.10
51093532-1093532101.324102.15
61116747-1116747103.475104.33
极限11086837-1086837100.703101.341.02101.70102.341.03
21093387-1093387101.310102.32
31090113-1090113101.007102.00
41082899-1082899100.339101.30
51094433-1094433101.407102.40
61114729-1114729103.288104.31
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%
117.319466519459759463189461679459779462180.03
217.329483389478369480870.04
单位质量响应值RSD%判断
54663.0854739.430.10数据可信
影响因素30天-供试品溶液-2024051911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%
5min11026034-102603494.97696.171.4694.9896.171.46
21027716-102771695.13195.13
31066407-106640798.71398.71
41045877-104587796.81296.81
51033462-103346295.66395.66
61033923-103392395.70695.71
10min11062081-106208198.31299.371.2198.4799.521.21
21057714-105771497.90898.07
31093435-1093435101.215101.38
41073945-107394599.41199.57
51081226-1081226100.084100.24
61072362-107236299.26499.42
15min11074275-107427599.441100.611.3099.76100.941.30
21068952-106895298.94899.27
31100339-1100339101.854102.19
41083407-1083407100.286100.61
51104241-1104241102.215102.54
61090263-1090263100.921101.25
20min11079502-107950299.925101.141.37100.41101.631.37
21075737-107573799.576100.06
31104233-1104233102.214102.72
41086108-1086108100.536101.03
51114105-1114105103.128103.62
61096181-1096181101.469101.96
30min11084759-1084759100.412101.481.27101.07102.151.26
21080513-1080513100.018100.67
31108976-1108976102.653103.33
41089928-1089928100.890101.55
51115440-1115440103.252103.92
61098448-1098448101.679102.34
45min11085013-1085013100.435101.341.07101.26102.181.07
21087469-1087469100.662101.48
31106319-1106319102.407103.25
41088254-1088254100.735101.56
51112686-1112686102.997103.84
61089319-1089319100.834101.67
极限11083360-1083360100.282101.231.31101.27102.231.31
21075649-107564999.568100.56
31104214-1104214102.212103.23
41086264-1086264100.551101.55
51113699-1113699103.090104.10
61098149-1098149101.651102.65
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%
117.319520879513969509489504859507599511350.07
217.329717429719479718440.02
单位质量响应值RSD%判断
54947.1456111.091.49数据可信
影响因素30天-供试品溶液-2024051911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%
5min11015184-101518492.58092.881.6392.5892.881.63
21030778-103077894.00394.00
31009010-100901092.01792.02
41045080-104508095.30795.31
51011342-101134292.23092.23
6999524-99952491.15291.15
10min11045653-104565395.35996.681.6595.5196.841.66
21072510-107251097.80897.96
31054712-105471296.18596.34
41089498-108949899.35899.52
51044868-104486895.28795.44
61053667-105366796.09096.24
15min11051567-105156795.89897.821.6096.2198.131.60
21084831-108483198.93299.25
31067016-106701697.30797.62
41099061-1099061100.230100.55
51060934-106093496.75397.07
61072247-107224797.78498.10
20min11054982-105498296.21098.311.5496.6898.791.54
21088093-108809399.22999.71
31072725-107272597.82898.30
41103680-1103680100.651101.14
51070463-107046397.62298.10
61078151-107815198.32398.80
30min11062129-106212996.86298.661.4597.5099.301.44
21090659-109065999.463100.11
31079630-107963098.45899.10
41106076-1106076100.869101.53
51069390-106939097.52498.16
61082950-108295098.76099.40
45min11066146-106614697.22898.611.3398.0299.421.33
21088364-108836499.254100.07
31076477-107647798.17098.97
41104740-1104740100.748101.57
51068376-106837697.43198.23
61083949-108394998.85199.66
极限11062398-106239896.88698.411.4097.8499.381.40
21087048-108704899.134100.12
31075985-107598598.12599.09
41103216-1103216100.609101.60
51064910-106491097.11598.08
61081362-108136298.61699.58
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%
117.314743684746634745834738634739984742950.08
217.324753054751134752090.03
单位质量响应值RSD%判断
27400.0627437.010.10数据可信
影响因素30天-供试品溶液-2024051711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%
5min1527788-52778897.46897.712.0497.4797.712.04
2525946-52594697.12897.13
3544436-544436100.543100.54
4521318-52131896.27396.27
5516072-51607295.30595.30
6539095-53909599.55699.56
10min1533597-53359798.54198.821.6098.7098.981.60
2532817-53281798.39798.56
3542767-542767100.234100.40
4531978-53197898.24298.40
5522829-52282996.55296.71
6546785-546785100.976101.14
15min1532218-53221898.28698.691.6198.6199.021.61
2531683-53168398.18798.51
3542464-542464100.178100.51
4531118-53111898.08398.41
5522614-52261496.51396.83
6546347-546347100.896101.23
20min1531837-53183798.21698.641.5398.7199.141.52
2533475-53347598.51899.01
3541401-54140199.982100.48
4531415-53141598.13898.63
5521928-52192896.38696.87
6544863-544863100.621101.12
30min1530019-53001997.88098.691.6398.5399.341.63
2536534-53653499.08399.74
3541995-541995100.092100.76
4532803-53280398.39499.05
5520591-52059196.13996.78
6544423-544423100.540101.21
45min1530709-53070998.00898.981.5898.8299.801.58
2540156-54015699.752100.57
3543195-543195100.313101.15
4534574-53457498.72199.54
5522536-52253696.49897.30
6544641-544641100.580101.42
极限1533729-53372998.56599.591.5899.55100.581.58
2545078-545078100.661101.65
3543720-543720100.410101.41
4540000-54000099.723100.70
5525169-52516996.98597.95
6547997-547997101.200102.21
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