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%
112.153834353825013832263848383838073835610.23
212.103841263854103847680.24
单位质量响应值RSD%判断
31568.8131799.010.52数据可信
加速6月-供试品溶液-2024072521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%
5min1376896-37689689.78788.096.1089.7988.096.10
2360069-36006985.77985.78
3339675-33967580.92080.92
4396636-39663694.49094.49
5392036-39203693.39493.39
6353299-35329984.16684.17
10min1404329-40432996.32395.443.3196.4795.593.31
2391264-39126493.21093.35
3383587-38358791.38191.52
4422368-422368100.620100.78
5403588-40358896.14696.30
6398727-39872794.98895.13
15min1405681-40568196.64596.812.3196.9597.112.32
2403846-40384696.20896.51
3391928-39192893.36893.66
4421172-421172100.335100.66
5406872-40687296.92997.24
6408632-40863297.34897.65
20min1408088-40808897.21896.932.4497.6997.402.45
2398078-39807894.83495.29
3393579-39357993.76294.20
4421539-421539100.423100.92
5409205-40920597.48497.96
6410845-41084597.87598.34
30min1412131-41213198.18198.232.0698.8198.862.07
2402120-40212095.79696.41
3404392-40439296.33896.94
4424688-424688101.173101.83
5412076-41207698.16898.81
6418700-41870099.746100.37
45min1410215-41021597.72598.851.9998.5299.651.99
2407983-40798397.19397.97
3409231-40923197.49098.25
4425889-425889101.459102.29
5411296-41129697.98298.79
6425123-425123101.276102.07
60min1409766-40976697.61898.962.1498.5899.922.13
2406385-40638596.81297.75
3409354-40935497.52098.44
4424363-424363101.095102.09
5414465-41446598.73799.70
6428140-428140101.995102.95
极限1410878-41087897.88399.272.6499.01100.392.63
2407562-40756297.09398.19
3413227-41322798.44299.53
4425444-425444101.353102.52
5408273-40827397.26298.39
6434782-434782103.577104.71
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%
112.153892173904793907173906463917993905720.24
212.103843643823003833320.39
单位质量响应值RSD%判断
32145.8431680.331.04数据可信
加速6月-供试品溶液-2024072522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%
5min1395848-39584893.62986.7811.2593.6386.7811.24
2385365-38536591.14991.15
3359095-35909584.93684.94
4379466-37946689.75489.75
5394346-39434693.27493.27
6287188-28718867.92867.93
10min1413329-41332997.76495.644.3097.9295.784.31
2404470-40447095.66895.82
3398581-39858194.27594.42
4418144-41814498.90299.05
5418761-41876199.04899.20
6372771-37277188.17088.28
15min1415324-41532498.23596.823.0098.5597.123.01
2406194-40619496.07696.39
3404838-40483895.75596.05
4420149-42014999.37799.69
5420959-42095999.56899.89
6388477-38847791.88592.15
20min1416961-41696198.62397.632.5399.1198.102.55
2408430-40843096.60597.08
3410932-41093297.19797.65
4420783-42078399.527100.01
5424330-424330100.366100.85
6395234-39523493.48493.90
30min1415851-41585198.36098.451.5499.0199.081.55
2412839-41283997.64898.28
3413630-41363097.83598.46
4423254-423254100.111100.76
5424088-424088100.308100.96
6407667-40766796.42496.99
45min1418718-41871899.03899.550.9299.85100.340.92
2419714-41971499.274100.07
3416933-41693398.61699.40
4422316-42231699.889100.70
5427866-427866101.202102.02
6419816-41981699.298100.03
60min1418131-41813198.89999.241.2199.88100.191.20
2412645-41264597.60298.56
3416154-41615498.43299.38
4419830-41983099.301100.28
5426061-426061100.775101.76
6424495-424495100.405101.30
极限1416516-41651698.51799.411.4399.66100.541.41
2411310-41131097.28698.41
3418939-41893999.090100.20
4421854-42185499.780100.92
5426286-426286100.828101.99
6426923-426923100.979102.04
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%
112.153841433837823829063830983837183835290.14
212.103851913845393848650.12
单位质量响应值RSD%判断
31566.1731807.020.54数据可信
加速6月-供试品溶液-2024072621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%
5min1385016-38501691.71488.013.9091.7188.013.90
2359745-35974585.69485.69
3383105-38310591.25991.26
4376068-37606889.58389.58
5348360-34836082.98282.98
6364452-36445286.81686.82
10min1415962-41596299.08697.873.0499.2498.013.03
2403264-40326496.06196.20
3412638-41263898.29498.45
4413139-41313998.41398.56
5428511-428511102.075102.21
6391582-39158293.27893.42
15min1416963-41696399.32497.891.9499.6498.201.93
2406770-40677096.89697.20
3416765-41676599.27799.59
4418470-41847099.683100.00
5408460-40846097.29997.61
6398118-39811894.83595.14
20min1421259-421259100.34898.631.83100.8399.101.84
2411725-41172598.07698.54
3416880-41688099.30499.79
4421412-421412100.384100.86
5411791-41179198.09298.56
6401308-40130895.59596.05
30min1419975-419975100.04299.782.26100.69100.422.25
2416418-41641899.19499.82
3420326-420326100.125100.77
4434256-434256103.444104.09
5417434-41743499.436100.07
6404821-40482196.43297.05
45min1419266-41926699.873100.550.94100.69101.350.93
2420888-420888100.259101.05
3416492-41649299.212100.03
4426440-426440101.582102.40
5426139-426139101.510102.31
6423360-423360100.848101.63
60min1416657-41665799.251100.051.76100.24101.031.75
2421266-421266100.349101.31
3414706-41470698.78799.77
4426132-426132101.508102.50
5430509-430509102.551103.52
6410860-41086097.87098.82
极限1423249-423249100.822100.521.96101.97101.661.95
2427971-427971101.946103.07
3415766-41576699.039100.18
4425835-425835101.438102.60
5430524-430524102.555103.69
6408660-40866097.34698.46
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%
112.153813643865813865983833773830323841900.61
212.103810313832153821230.41
单位质量响应值RSD%判断
31620.5831580.410.09数据可信
加速6月-供试品溶液-BXJVV61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%
5min1364030-36403086.95086.190.9686.9586.190.96
2358125-35812585.54085.54
3355382-35538284.88584.88
4361244-36124486.28586.28
5363746-36374686.88286.88
6362608-36260886.61086.61
10min1388483-38848392.79192.360.8092.9492.510.80
2384427-38442791.82291.96
3384123-38412391.74991.89
4386753-38675392.37892.52
5384426-38442691.82291.97
6391919-39191993.61293.76
15min1395175-39517594.38994.040.5194.6994.340.51
2395053-39505394.36094.66
3392286-39228693.69993.99
4391282-39128293.45993.76
5392296-39229693.70294.00
6396163-39616394.62594.93
20min1396534-39653494.71494.630.7495.1795.080.74
2400816-40081695.73796.19
3395112-39511294.37494.82
4391772-39177293.57694.03
5396364-39636494.67395.13
6396421-39642194.68795.14
30min1400576-40057695.67995.320.9496.2995.930.94
2404873-40487396.70697.32
3397293-39729394.89595.50
4394294-39429494.17994.79
5400699-40069995.70996.32
6396731-39673194.76195.38
45min1399248-39924895.36295.600.8996.1496.370.88
2405358-40535896.82197.60
3398338-39833895.14595.91
4395392-39539294.44195.21
5403094-40309496.28197.05
6400034-40003495.55096.32
60min1400576-40057695.67995.570.9996.6196.500.98
2407226-40722697.26898.20
3397868-39786895.03295.96
4395856-39585694.55295.48
5400823-40082395.73896.67
6398258-39825895.12696.06
极限1400606-40060695.68695.701.0696.7896.791.05
2407505-40750597.33498.43
3396411-39641194.68495.77
4397136-39713694.85895.94
5403630-40363096.40997.50
6398766-39876695.24796.34
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