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%
117.319335229336109331819389779316879341950.30
217.329235139308249271680.56
单位质量响应值RSD%判断
53968.5253531.640.58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%
5min1810388-81038876.34392.298.5276.3492.298.52
21014583-101458395.57995.58
31008769-100876995.03195.03
41004921-100492194.66994.67
51029655-102965596.99997.00
61009904-100990495.13895.14
10min11057214-105721499.59598.371.0999.7298.521.08
21040082-104008297.98198.14
31034687-103468797.47397.63
41032452-103245297.26297.42
51058951-105895199.75999.92
61041667-104166798.13198.29
15min11081590-1081590101.89299.421.58102.1899.741.57
21042107-104210798.17298.49
31036536-103653697.64797.97
41047978-104797898.72599.05
51065592-1065592100.384100.71
61058465-105846599.713100.04
20min11094571-1094571103.114100.261.61103.58100.741.60
21057942-105794299.664100.15
31065345-1065345100.361100.84
41046579-104657998.59399.08
51069561-1069561100.758101.25
61051476-105147699.05599.54
30min11075413-1075413101.31099.990.87101.94100.640.86
21047050-104705098.63899.29
31064856-1064856100.315100.97
41057976-105797699.667100.32
51061847-1061847100.032100.69
61061509-1061509100.000100.65
45min11088089-1088089102.504100.401.11103.31101.221.09
21058097-105809799.678100.50
31068096-1068096100.620101.44
41055760-105576099.458100.27
51062129-1062129100.058100.89
61062351-1062351100.079100.90
极限11087657-1087657102.463100.371.11103.44101.351.10
21059459-105945999.807100.79
31068607-1068607100.668101.65
41054614-105461499.350100.33
51060368-106036899.892100.89
61061701-1061701100.018101.00
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%
117.319210999339359309649302149324909297400.55
217.329215029234589224800.15
单位质量响应值RSD%判断
53711.1553260.970.60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%
5min1435305-43530541.21143.559.5341.2143.549.53
2473472-47347244.82444.82
3490036-49003646.39246.39
4409925-40992538.80838.81
5525137-52513749.71549.71
6426035-42603540.33340.33
10min1452092-45209242.80044.656.9642.8744.726.96
2479351-47935145.38045.46
3487729-48772946.17446.25
4437155-43715541.38641.45
5525635-52563549.76249.84
6447584-44758442.37342.44
15min1455391-45539143.11244.747.9043.2544.887.90
2476275-47627545.08945.24
3477055-47705545.16345.32
4438456-43845641.50941.64
5541682-54168251.28151.45
6446407-44640742.26242.40
20min1457353-45735343.29844.296.1643.5144.516.16
2481336-48133645.56845.79
3472770-47277044.75744.99
4435035-43503541.18541.39
5515140-51514048.76949.02
6445246-44524642.15242.36
30min1451433-45143342.73743.656.2243.0243.956.23
2469056-46905644.40644.71
3461772-46177243.71644.02
4430113-43011340.71940.99
5512325-51232548.50248.83
6441858-44185841.83142.11
45min1442909-44290941.93042.715.2642.2943.085.27
2457095-45709543.27343.65
3451434-45143442.73743.11
4424966-42496640.23240.57
5493686-49368646.73747.15
6436644-43664441.33741.69
极限1419219-41921939.68840.784.0940.1141.224.12
2439227-43922741.58242.03
3430071-43007140.71541.16
4419688-41968839.73240.14
5461836-46183643.72244.21
6414740-41474039.26439.68
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%
117.319387629389979389279396449389759390610.04
217.329214839280879247850.51
单位质量响应值RSD%判断
54249.6253394.051.13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%
5min11016404-101640495.62795.851.2395.6395.851.23
21024064-102406496.34896.35
31035112-103511297.38897.39
41011494-101149495.16695.17
5999580-99958094.04594.04
61025981-102598196.52996.53
10min11049490-104949098.74099.011.1898.9099.161.18
21057525-105752599.49699.66
31067431-1067431100.428100.59
41044231-104423198.24698.40
51033690-103369097.25497.41
61061468-106146899.867100.03
15min11057233-105723399.46999.931.1999.79100.261.19
21061119-106111999.834100.16
31074265-1074265101.071101.40
41047847-104784798.58698.91
51052351-105235199.01099.33
61080002-1080002101.611101.94
20min11049339-104933998.726100.251.4599.22100.741.45
21075228-1075228101.162101.65
31086871-1086871102.257102.76
41055530-105553099.30999.80
51051579-105157998.93799.42
61074769-1074769101.119101.62
30min11065063-1065063100.206100.631.24100.86101.281.24
21069781-1069781100.649101.31
31090468-1090468102.596103.26
41057190-105719099.465100.12
51056092-105609299.361100.01
61078702-1078702101.489102.15
45min11044041-104404198.228101.672.7199.05102.502.68
21073735-1073735101.021101.85
31086704-1086704102.242103.08
41132134-1132134106.516107.33
51067083-1067083100.396101.21
61080263-1080263101.636102.47
极限11055499-105549999.306100.151.21100.29101.141.21
21073893-1073893101.036102.03
31078816-1078816101.499102.51
41052041-105204198.98099.98
51051014-105101498.88499.87
61075374-1075374101.176102.18
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%
117.319242619348959346949345809346729326200.51
217.329254829277979266400.18
单位质量响应值RSD%判断
53877.5353501.150.50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%
5min1479661-47966145.23841.8612.5245.2441.8612.53
2405577-40557738.25138.25
3487923-48792346.01746.02
4372471-37247135.12835.13
5509747-50974748.07548.08
6407696-40769638.45038.45
10min1482131-48213145.47142.988.7245.5543.058.72
2431256-43125640.67240.74
3486811-48681145.91245.99
4407131-40713138.39738.46
5502984-50298447.43747.52
6423731-42373139.96340.03
15min1488198-48819846.04343.118.1846.1943.268.19
2438100-43810041.31841.45
3483411-48341145.59145.74
4414133-41413339.05839.18
5498943-49894347.05647.22
6420081-42008139.61839.75
20min1481144-48114445.37742.877.3045.6143.087.31
2442493-44249341.73241.93
3472516-47251644.56444.79
4418352-41835239.45539.64
5495009-49500946.68546.92
6417539-41753939.37939.58
30min1473237-47323744.63242.237.2144.9442.517.22
2439613-43961341.46141.73
3465064-46506443.86144.16
4412114-41211438.86739.12
5486433-48643345.87646.19
6410097-41009738.67738.94
45min1462296-46229643.60041.266.5243.9841.626.54
2427723-42772340.33940.68
3449377-44937742.38142.76
4408423-40842338.51938.84
5472890-47289044.59944.99
6404110-40411038.11238.44
极限1432652-43265240.80439.125.8041.2539.545.82
2409120-40912038.58538.99
3424336-42433640.02040.47
4389321-38932136.71737.10
5446509-44650942.11142.58
6386682-38668236.46936.86
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