盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.807613647606057613847610127614217611570.05
211.797732627711707722160.20
单位质量响应值RSD%判断
64504.8365497.541.08数据可信
长期12月-供试品溶液-2024072721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1755910-75591087.78186.542.0987.7886.542.09
2738697-73869785.78285.78
3720065-72006583.61983.62
4740355-74035585.97585.97
5763856-76385688.70488.70
6752426-75242687.37687.38
10min1790951-79095191.85091.332.3292.0091.472.32
2778091-77809190.35790.50
3754618-75461887.63187.77
4807704-80770493.79693.94
5792717-79271792.05592.20
6794554-79455492.26992.41
15min1809932-80993294.05492.982.2394.3593.282.23
2797727-79772792.63792.93
3766475-76647589.00889.29
4816184-81618494.78095.08
5806110-80611093.61193.91
6807780-80778093.80594.10
20min1815964-81596494.75593.802.1895.2194.252.17
2804864-80486493.46693.91
3773872-77387289.86790.30
4820202-82020295.24795.70
5819648-81964895.18395.64
6811770-81177094.26894.72
30min1822058-82205895.46394.880.7896.0895.490.79
2813413-81341394.45995.06
3807056-80705693.72094.30
4819713-81971395.19095.81
5824325-82432595.72696.34
6815724-81572494.72795.34
45min1825647-82564795.87994.621.8996.6595.381.88
2820115-82011595.23796.00
3784035-78403591.04791.79
4819165-81916595.12795.90
5822550-82255095.52096.30
6817071-81707194.88395.65
60min1828639-82863996.22794.791.8697.1695.721.86
2820922-82092295.33196.25
3786284-78628491.30892.20
4818868-81886895.09296.03
5824176-82417695.70996.64
6818756-81875695.07996.01
极限1828380-82838096.19794.661.9497.2995.751.93
2820127-82012795.23896.32
3783857-78385791.02692.07
4818549-81854995.05596.15
5820335-82033595.26396.36
6819889-81988995.21196.30
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.807694707687537684757676607653777679470.21
211.797688607668467678530.19
单位质量响应值RSD%判断
65080.2565127.480.06数据可信
长期12月-供试品溶液-2024072721批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1778759-77875990.28789.352.9690.2989.352.96
2780550-78055090.49490.49
3801227-80122792.89192.89
4776283-77628389.99990.00
5740757-74075785.88185.88
6746623-74662386.56186.56
10min1825045-82504595.65393.272.7495.8093.422.74
2811828-81182894.12094.27
3828564-82856496.06196.22
4800675-80067592.82792.98
5770414-77041489.31989.46
6790622-79062291.66291.81
15min1827211-82721195.90494.122.0196.2194.422.02
2815529-81552994.55094.86
3829053-82905396.11796.43
4812030-81203094.14494.45
5786052-78605291.13291.42
6800917-80091792.85593.15
20min1833654-83365496.65194.641.6797.1295.101.68
2817236-81723694.74795.21
3829138-82913896.12796.60
4814040-81404094.37794.84
5797057-79705792.40892.85
6806987-80698793.55994.01
30min1830849-83084996.32694.881.3096.9695.501.30
2815182-81518294.50995.13
3831926-83192696.45197.09
4814308-81430894.40895.03
5812338-81233894.18094.78
6805828-80582893.42594.03
45min1833618-83361896.64795.451.2797.4496.221.27
2818633-81863394.90995.69
3838095-83809597.16697.96
4816564-81656494.67095.45
5821628-82162895.25796.01
6811094-81109494.03594.80
60min1827930-82793095.98795.130.9896.9496.070.98
2815537-81553794.55095.49
3828976-82897696.10997.07
4813420-81342094.30595.24
5826154-82615495.78196.69
6811210-81121094.04994.97
极限1831496-83149696.40195.321.0797.5196.411.06
2815893-81589394.59295.69
3827524-82752495.94097.06
4814733-81473394.45795.55
5830796-83079696.32097.39
6812358-81235894.18295.26
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.807602947581097577427570487567287579840.19
211.797654527611507633010.40
单位质量响应值RSD%判断
64235.9364741.390.56数据可信
长期12月-供试品溶液-2024072921批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1818888-81888895.84688.368.7195.8588.368.71
2643344-64334475.30075.30
3800511-80051193.69593.70
4713330-71333083.49183.49
5764790-76479089.51489.51
6788967-78896792.34492.34
10min1841390-84139098.48092.575.6898.6492.725.69
2724834-72483484.83884.96
3815814-81581495.48695.64
4747406-74740687.48087.62
5801969-80196993.86694.02
6813862-81386295.25895.41
15min1836780-83678097.94093.874.1298.2694.174.13
2752406-75240688.06588.33
3822203-82220396.23496.55
4770469-77046990.17990.46
5812053-81205395.04695.35
6818164-81816495.76196.07
20min1838862-83886298.18494.944.0998.6795.404.10
2761838-76183889.16989.58
3821963-82196396.20696.68
4778833-77883391.15891.59
5842863-84286398.65299.12
6822588-82258896.27996.75
30min1837435-83743598.01794.752.7398.6795.372.74
2778573-77857391.12791.69
3822122-82212296.22596.86
4788677-78867792.31092.90
5811340-81134094.96395.59
6819207-81920795.88396.52
45min1842220-84222098.57795.562.1499.3996.332.15
2801316-80131693.78994.50
3823842-82384296.42697.22
4793671-79367192.89593.64
5814480-81448095.33096.12
6823025-82302596.33097.12
60min1836737-83673797.93595.651.4198.9196.581.43
2809892-80989294.79395.66
3819305-81930595.89596.85
4802977-80297793.98494.88
5814266-81426695.30596.25
6819989-81998995.97596.93
极限1834867-83486797.71696.151.3298.8697.241.33
2828799-82879997.00698.03
3820095-82009595.98797.10
4802729-80272993.95595.01
5821381-82138196.13897.24
6821107-82110796.10697.22
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.807600707604887592537583667588887594130.12
211.797616937619547618240.03
单位质量响应值RSD%判断
64357.0364616.120.29数据可信
长期12月-供试品溶液-2024072921批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1768355-76835589.93388.585.7989.9388.585.79
2761239-76123989.10189.10
3669399-66939978.35178.35
4779386-77938691.22591.22
5788252-78825292.26292.26
6774376-77437690.63890.64
10min1811443-81144394.97794.122.0495.1394.272.05
2803347-80334794.02994.18
3774558-77455890.65990.79
4799539-79953993.58393.74
5819928-81992895.97096.12
6815949-81594995.50495.66
15min1822203-82220396.23695.441.4496.5495.751.44
2808232-80823294.60194.91
3800103-80010393.64993.93
4807357-80735794.49894.81
5825872-82587296.66696.98
6828770-82877097.00597.32
20min1823494-82349496.38795.871.6296.8696.341.62
2804430-80443094.15694.62
3810013-81001394.80995.25
4809537-80953794.75495.22
5828394-82839496.96197.44
6838570-83857098.15298.62
30min1834782-83478297.70896.611.8298.3497.231.82
2806472-80647294.39595.01
3820674-82067496.05796.65
4811309-81130994.96195.58
5833942-83394297.61098.25
6844978-84497898.90299.54
45min1838613-83861398.15796.691.7298.9597.481.72
2806293-80629394.37495.15
3814981-81498195.39196.15
4820310-82031096.01596.80
5838405-83840598.13398.93
6838024-83802498.08898.89
60min1826344-82634496.72195.742.9897.6896.682.95
2808270-80827094.60595.54
3831857-83185797.36698.28
4814261-81426195.30796.25
5777695-77769591.02791.99
6849216-84921699.398100.36
极限1831922-83192297.37496.671.6398.4997.771.62
2808889-80888994.67895.77
3831543-83154397.32998.41
4809112-80911294.70495.80
5834053-83405397.62398.74
6839710-83971098.28599.41
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