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%
117.154699394696374693854693424694474695500.06
217.054694574694584694580.01
单位质量响应值RSD%判断
27379.0127534.190.40数据可信
长期24月-供试品溶液-2022051601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%
5min1506143-50614393.34293.430.6893.3493.430.68
2502307-50230792.63592.63
3509082-50908293.88493.88
4505075-50507593.14593.15
5505055-50505593.14193.14
6512029-51202994.42894.43
10min1515541-51554195.07596.742.9795.2396.902.96
2514758-51475894.93195.09
3521414-52141496.15896.31
4555056-555056102.363102.52
5515168-51516895.00695.16
6525630-52563096.93697.09
15min1516478-51647895.24895.850.8695.5696.170.86
2517094-51709495.36295.67
3523371-52337196.51996.84
4518107-51810795.54895.87
5516401-51640195.23495.55
6527017-52701797.19297.51
20min1516113-51611395.18195.790.8895.6596.260.88
2516649-51664995.28095.75
3523891-52389196.61597.09
4516270-51627095.21095.69
5517045-51704595.35395.82
6526493-52649397.09597.58
30min1514925-51492594.96295.590.9595.5996.220.95
2515057-51505794.98695.62
3522821-52282196.41897.06
4513903-51390394.77395.42
5517266-51726695.39396.02
6525914-52591496.98897.63
45min1513286-51328694.65995.470.9595.4596.270.95
2514978-51497894.97195.76
3521799-52179996.22997.03
4515126-51512694.99995.80
5515286-51528695.02895.82
6525619-52561996.93497.74
极限1513726-51372694.74095.250.8395.6996.200.83
2514555-51455594.89395.84
3520155-52015595.92696.89
4512908-51290894.59095.55
5514060-51406094.80295.75
6523439-52343996.53297.50
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%
117.154689884687134685984684044682564685920.07
217.054702464701494701980.02
单位质量响应值RSD%判断
27323.1527577.600.66数据可信
长期24月-供试品溶液-2022051602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%
5min1508144-50814493.73492.891.1293.7392.891.12
2506678-50667893.46393.46
3501651-50165192.53692.54
4499397-49939792.12092.12
5495516-49551691.40491.40
6510040-51004094.08394.08
10min1519704-51970495.86695.131.0096.0295.281.00
2511655-51165594.38194.54
3515722-51572295.13195.29
4519814-51981495.88696.04
5507532-50753293.62193.77
6519714-51971495.86896.02
15min1522075-52207596.30395.631.6196.6295.951.61
2512105-51210594.46494.78
3517935-51793595.54095.85
4519672-51967295.86096.17
5507427-50742793.60193.91
6531445-53144598.03298.35
20min1521239-52123996.14995.281.0596.6395.761.05
2511042-51104294.26894.74
3517345-51734595.43195.90
4519117-51911795.75896.23
5508809-50880993.85694.32
6521732-52173296.24096.72
30min1521696-52169696.23395.451.0996.8796.091.09
2512583-51258394.55295.18
3521032-52103296.11196.74
4518443-51844395.63396.27
5508647-50864793.82694.45
6522450-52245096.37397.01
45min1519939-51993995.90995.201.0896.7195.991.08
2509229-50922993.93494.72
3520679-52067996.04696.84
4518214-51821495.59196.38
5508778-50877893.85194.63
6519772-51977295.87996.68
极限1517711-51771195.49895.051.0796.4696.001.07
2509329-50932993.95294.89
3519920-51992095.90696.86
4517656-51765695.48896.44
5507339-50733993.58594.52
6519640-51964095.85496.81
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%
117.154673574673244670064671514665274670730.08
217.054683284684474683880.02
单位质量响应值RSD%判断
27234.5827471.440.62数据可信
长期24月-供试品溶液-2022051701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%
5min1524353-52435397.06895.771.1497.0795.771.14
2514081-51408195.16695.17
3515765-51576595.47895.48
4523523-52352396.91496.91
5517480-51748095.79595.80
6508902-50890294.20794.21
10min1531755-53175598.43897.251.3798.6097.411.37
2516606-51660695.63395.79
3526841-52684197.52897.69
4532400-53240098.55798.72
5527934-52793497.73097.89
6516422-51642295.59995.76
15min1532806-53280698.63297.841.1198.9698.161.11
2517727-51772795.84196.16
3528611-52861197.85698.18
4534479-53447998.94299.27
5528105-52810597.76298.08
6529395-52939598.00198.32
20min1532519-53251998.57997.561.4499.0798.041.44
2516853-51685395.67996.16
3528803-52880397.89198.38
4534944-53494499.02899.52
5530417-53041798.19098.68
6518434-51843495.97296.45
30min1530862-53086298.27397.581.2298.9398.231.21
2517572-51757295.81296.45
3528062-52806297.75498.40
4535267-53526799.08899.74
5529192-52919297.96398.61
6521925-52192596.61897.26
45min1530312-53031298.17197.820.7998.9998.630.79
2522251-52225196.67897.48
3528546-52854697.84498.65
4533376-53337698.73899.56
5531103-53110398.31799.13
6524964-52496497.18197.98
极限1528895-52889597.90897.670.6098.8998.640.60
2526188-52618897.40798.37
3526378-52637897.44298.42
4531785-53178598.44399.43
5529468-52946898.01498.99
6522803-52280396.78197.74
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