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125
标示量(mg)100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%
1 17.249606469621959627449621029622229619820.09
2 17.249687479607389647420.59
单位质量响应值RSD%判断
55799.4255959.510.21数据可信
供试品溶液-8184807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%
5min11081298-108129897.98197.141.9297.9897.141.92
21080148-108014897.87797.88
31089914-108991498.76298.76
41088471-108847198.63198.63
51041822-104182294.40494.40
61050587-105058795.19895.20
10min11098466-109846699.53799.481.7999.7099.641.79
21103715-1103715100.012100.18
31122748-1122748101.737101.90
41111185-1111185100.689100.85
51069411-106941196.90497.06
61081463-108146397.99698.15
15min11098919-109891999.57899.851.5799.91100.181.57
21106316-1106316100.248100.58
31125730-1125730102.007102.34
41114664-1114664101.004101.34
51080123-108012397.87498.19
61085939-108593998.40198.72
20min11100069-110006999.68299.751.93100.18100.241.92
21107502-1107502100.355100.85
31127912-1127912102.205102.71
41114132-1114132100.956101.46
51067665-106766596.74697.23
61087353-108735398.53099.02
30min11105520-1105520100.17699.781.76100.84100.441.75
21106946-1106946100.305100.97
31122744-1122744101.737102.41
41113409-1113409100.891101.56
51068739-106873996.84397.49
61089378-108937898.71399.36
45min11103017-110301799.949100.042.21100.78100.872.21
21105781-1105781100.199101.03
31123771-1123771101.830102.67
41135220-1135220102.867103.70
51066720-106672096.66097.46
61089706-108970698.74399.56
极限11100552-110055299.72699.521.91100.72100.521.91
21103526-110352699.995100.99
31123464-1123464101.802102.82
41113087-1113087100.861101.87
51064836-106483696.48997.45
61084550-108455098.27699.25
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125
标示量(mg)100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%
1 17.249616279627029609099620849627819620210.09
2 17.249599609629519614560.22
单位质量响应值RSD%判断
55801.6855768.910.05数据可信
供试品溶液-8184807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%
5min1998259-99825990.60993.423.3190.6193.423.31
2979064-97906488.86788.87
31068141-106814196.95296.95
41053827-105382795.65395.65
51042457-104245794.62194.62
61033643-103364393.82193.82
10min11087261-108726198.68797.841.0698.8497.991.06
21070212-107021297.14097.29
31093371-109337199.24299.40
41082005-108200598.21098.37
51069811-106981197.10397.26
61064774-106477496.64696.80
15min11090706-109070699.00098.191.1299.3298.511.12
21075657-107565797.63497.94
31099067-109906799.759100.09
41084565-108456598.44398.77
51075241-107524197.59697.92
61065647-106564796.72697.04
20min11090783-109078399.00798.191.1599.4998.681.15
21076090-107609097.67398.15
31099024-109902499.755100.25
41085507-108550798.52899.02
51075136-107513697.58798.07
61064453-106445396.61797.10
30min11089751-108975198.91398.361.0999.5699.011.09
21093889-109388999.28999.92
31094982-109498299.388100.05
41085101-108510198.49199.14
51070954-107095497.20797.85
61067501-106750196.89497.53
45min11092157-109215799.13298.071.1599.9498.881.14
21077043-107704397.76098.56
31094136-109413699.311100.14
41085154-108515498.49699.31
51071453-107145397.25398.06
61062544-106254496.44497.25
极限11108195-1108195100.58798.361.36101.5699.331.35
21074724-107472497.54998.51
31093710-109371099.273100.26
41079515-107951597.98498.96
51068305-106830596.96797.94
61077204-107720497.77598.74
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125
标示量(mg)100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%
1 17.249620809615659620199617189623929619550.04
2 17.249616159616209616180.01
单位质量响应值RSD%判断
55797.8555778.310.03数据可信
供试品溶液-8184807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%
5min1536373-53637348.68343.6217.7548.6843.6217.75
2544165-54416549.39049.39
3529031-52903148.01648.02
4413515-41351537.53237.53
5337225-33722530.60730.61
6523060-52306047.47447.47
10min1566704-56670451.43547.2010.3251.5247.2710.34
2558608-55860850.70150.78
3544129-54412949.38649.47
4499681-49968145.35245.41
5421780-42178038.28238.33
6529380-52938048.04848.13
15min1569226-56922651.66447.737.4151.8347.887.43
2557647-55764750.61350.78
3536113-53611348.65948.82
4502888-50288845.64345.78
5462123-46212341.94342.06
6527240-52724047.85448.01
20min1561904-56190451.00047.516.9951.2547.747.00
2551881-55188150.09050.34
3533453-53345348.41748.66
4501194-50119445.49045.70
5462208-46220841.95142.14
6529887-52988748.09448.33
30min1553213-55321350.21146.696.5050.5547.006.53
2540254-54025449.03549.37
3520211-52021147.21647.54
4497240-49724045.13145.42
5458937-45893741.65441.91
6516654-51665446.89347.21
45min1535080-53508048.56545.806.0148.9946.186.04
2529580-52958048.06648.48
3513397-51339746.59747.00
4490688-49068844.53644.90
5452060-45206041.03041.35
6506599-50659945.98046.38
极限1487811-48781144.27542.084.7344.7842.554.77
2480825-48082543.64144.14
3467407-46740742.42342.90
4452458-45245841.06641.51
5426665-42666538.72539.12
6466865-46686542.37442.85
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