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%
117.369563109570249560539551929556459560450.08
217.319560329546769553540.11
单位质量响应值RSD%判断
55071.7255190.870.16数据可信
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%
5min11027632-102763294.38293.831.3794.3893.831.37
21018586-101858693.55193.55
3997113-99711391.57991.58
41021182-102118293.78993.79
51026384-102638494.26794.27
61039054-103905495.43195.43
10min11073162-107316298.56397.650.9198.7297.810.91
21051377-105137796.56296.72
31058216-105821697.19197.34
41068486-106848698.13498.29
51054986-105498696.89497.05
61073361-107336198.58298.74
15min11086005-108600599.74398.711.00100.0699.030.99
21061501-106150197.49297.81
31072224-107222498.47798.79
41085141-108514199.66399.98
51063686-106368697.69398.01
61080031-108003199.19499.52
20min11089438-1089438100.05899.090.98100.5599.580.98
21066776-106677697.97798.46
31077202-107720298.93499.41
41090592-1090592100.164100.65
51067081-106708198.00598.49
61082529-108252999.42499.91
30min11090467-1090467100.15399.440.93100.81100.090.93
21071690-107169098.42899.07
31081275-108127599.30899.95
41095912-1095912100.653101.31
51071189-107118998.38299.03
61085720-108572099.717100.37
45min11087248-108724899.85799.270.94100.68100.080.94
21071021-107102198.36799.17
31077630-107763098.97499.78
41095772-1095772100.640101.46
51069593-106959398.23599.04
61084014-108401499.560100.38
极限11083579-108357999.52099.050.79100.51100.040.79
21068932-106893298.17599.15
31077607-107760798.97199.95
41090745-1090745100.178101.17
51069147-106914798.19599.17
61081065-108106599.289100.28
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%
117.369560379544219570129563959558869559500.11
217.319560879614219587540.40
单位质量响应值RSD%判断
55066.2455387.290.42数据可信
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%
5min1978503-97850389.71590.142.2189.7190.142.21
2996903-99690391.40291.40
31001997-100199791.86991.87
4950373-95037387.13687.14
51004143-100414392.06692.07
6967007-96700788.66188.66
10min11028366-102836694.28695.990.9994.4496.140.99
21050370-105037096.30496.46
31046442-104644295.94496.10
41049868-104986896.25896.40
51046525-104652595.95196.10
61059905-105990597.17897.33
15min11050186-105018696.28797.540.8796.5997.850.87
21067191-106719197.84698.16
31064177-106417797.57097.88
41062805-106280597.44497.75
51060187-106018797.20497.52
61078343-107834398.86999.18
20min11058163-105816397.01898.241.0297.4998.711.02
21079786-107978699.00199.48
31068969-106896998.00998.48
41068341-106834197.95298.42
51064907-106490797.63798.11
61088450-108845099.795100.27
30min11067102-106710297.83898.821.0298.4799.461.01
21087137-108713799.675100.32
31074034-107403498.47499.11
41071121-107112198.20698.84
51072410-107241098.32598.96
61095267-1095267100.420101.06
45min11064539-106453997.60398.711.0898.3999.521.08
21087181-108718199.679100.49
31070115-107011598.11498.92
41071391-107139198.23199.03
51071979-107197998.28599.09
61094585-1094585100.358101.17
极限11054257-105425796.66097.720.9997.6198.690.99
21075895-107589598.64499.62
31063967-106396797.55198.52
41059107-105910797.10598.06
51060508-106050897.23398.20
61081207-108120799.131100.11
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%
117.369542919568019564739569449556919560400.12
217.319575139580889578000.05
单位质量响应值RSD%判断
55071.4355332.180.34数据可信
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%
5min11009521-100952192.60092.831.0592.6092.831.05
21017943-101794393.37393.37
31009338-100933892.58392.58
41025199-102519994.03894.04
51016167-101616793.21093.21
6994265-99426591.20191.20
10min11055725-105572596.83897.090.5696.9997.240.56
21058794-105879497.12097.28
31059002-105900297.13997.29
41067390-106739097.90898.07
51060135-106013597.24397.40
61049496-104949696.26796.42
15min11071238-107123898.26198.320.6198.5898.640.61
21068806-106880698.03898.36
31072341-107234198.36298.68
41079653-107965399.03399.35
51077618-107761898.84799.16
61061499-106149997.36897.68
20min11082280-108228099.27498.870.7999.7599.340.79
21073633-107363398.48198.96
31075395-107539598.64399.12
41088418-108841899.837100.32
51082816-108281699.32399.81
61064428-106442897.63798.11
30min11086798-108679899.68999.120.71100.3399.760.71
21075641-107564198.66599.31
31078139-107813998.89499.54
41086708-108670899.680100.33
51087495-108749599.753100.40
61068772-106877298.03598.67
45min11084645-108464599.49199.070.79100.3099.880.79
21072441-107244198.37299.18
31077905-107790598.87399.68
41087654-108765499.767100.58
51089296-108929699.918100.73
61068444-106844498.00598.81
极限11082113-108211399.25998.780.71100.2499.750.71
21071394-107139498.27699.25
31076493-107649398.74399.72
41084534-108453499.481100.46
51081844-108184499.234100.21
61064655-106465597.65798.62
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