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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50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%
111.917565177569317566307560257561067564420.05
211.917494147488477491300.06
单位质量响应值RSD%判断
63513.1862899.240.69数据可信
供试品溶液-2024073021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%
5min1822010-82201098.57897.581.7198.5897.581.71
2814079-81407997.62797.63
3827393-82739399.22499.22
4796754-79675495.55095.55
5825268-82526898.96998.97
6796763-79676395.55195.55
10min1835504-835504100.19799.501.20100.3699.661.20
2835490-835490100.195100.36
3834314-834314100.054100.22
4820459-82045998.39298.55
5838107-838107100.509100.67
6814106-81410697.63197.79
15min1835885-835885100.24299.521.45100.5799.841.45
2833991-833991100.015100.34
3844503-844503101.276101.61
4817292-81729298.01398.34
5834104-834104100.029100.36
6813225-81322597.52597.85
20min1843068-843068101.10499.111.75101.6099.611.74
2833205-83320599.921100.42
3840079-840079100.745101.25
4807839-80783996.87997.37
5820213-82021398.36398.86
6814382-81438297.66498.15
30min1831098-83109899.66898.901.49100.3499.561.49
2815495-81549597.79798.46
3840156-840156100.755101.42
4816356-81635697.90098.55
5834877-834877100.121100.78
6810008-81000897.13997.79
45min1829824-82982499.51598.801.72100.3599.631.72
2830028-83002899.540100.37
3839953-839953100.730101.57
4813057-81305797.50598.32
5829333-82933399.457100.29
6801121-80112196.07396.88
60min1830737-83073799.62599.001.32100.6299.991.32
2830084-83008499.547100.54
3835299-835299100.172101.18
4814389-81438997.66498.64
5833284-83328499.930100.93
6809242-80924297.04798.02
极限1835381-835381100.18299.332.00101.35100.491.99
2831013-83101399.658100.82
3837742-837742100.465101.64
4808260-80826096.92998.07
5848931-848931101.807102.97
6808525-80852596.96198.09
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50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%
111.917555517558357547577554367555207554200.06
211.917555817549097552450.07
单位质量响应值RSD%判断
63427.3763412.680.02数据可信
供试品溶液-2024073021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%
5min1815443-81544397.45995.581.4497.4695.581.44
2810259-81025996.83996.84
3799993-79999395.61295.61
4793924-79392494.88794.89
5794276-79427694.92994.93
6784451-78445193.75593.75
10min1825935-82593598.71398.051.4998.8898.211.48
2829113-82911399.09399.25
3815787-81578797.50097.66
4820262-82026298.03598.19
5798824-79882495.47395.63
6832458-83245899.49299.65
15min1826867-82686798.82498.041.3799.1598.371.36
2830821-83082199.29799.62
3808658-80865896.64896.97
4819351-81935197.92698.25
5805399-80539996.25896.58
6830910-83091099.30799.63
20min1828321-82832198.99897.751.3399.4998.241.34
2826323-82632398.75999.25
3812407-81240797.09697.58
4816196-81619697.54998.03
5799612-79961295.56796.04
6824561-82456198.54999.04
30min1822977-82297798.35997.711.3099.0298.361.30
2827084-82708498.85099.51
3810369-81036996.85297.50
4817341-81734197.68698.33
5800285-80028595.64796.28
6827031-82703198.84499.50
45min1823251-82325198.39297.771.4099.2198.581.40
2830745-83074599.288100.11
3807784-80778496.54397.35
4819288-81928897.91898.73
5801128-80112895.74896.54
6826183-82618398.74299.56
60min1823173-82317398.38397.661.3999.3798.631.38
2829298-82929899.115100.10
3808773-80877396.66297.63
4819462-81946297.93998.91
5798636-79863695.45096.41
6823169-82316998.38299.36
极限1823448-82344898.41697.591.1799.5698.731.17
2821887-82188798.22999.38
3809199-80919996.71397.84
4819628-81962897.95999.10
5800790-80079095.70896.82
6824465-82446598.53799.68
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50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%
111.913756953754673756063754063752933754930.05
211.913759143755863757500.07
单位质量响应值RSD%判断
31527.5431549.120.05数据可信
供试品溶液-2024072621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%
5min1410550-41055098.66995.192.5198.6795.192.51
2396679-39667995.33695.34
3390676-39067693.89393.89
4403349-40334996.93996.94
5392950-39295094.43994.44
6382273-38227391.87391.87
10min1416809-416809100.17397.421.65100.3497.581.66
2405101-40510197.36097.52
3403379-40337996.94697.10
4408085-40808598.07798.24
5401448-40144896.48296.64
6397272-39727295.47895.63
15min1396898-39689895.38896.651.2995.7296.971.29
2402072-40207296.63296.95
3406149-40614997.61197.93
4409034-40903498.30598.63
5403167-40316796.89597.21
6395654-39565495.08995.40
20min1409607-40960798.44397.240.9698.9397.720.96
2403146-40314696.89097.37
3407672-40767297.97898.46
4401034-40103496.38296.87
5406300-40630097.64898.13
6399889-39988996.10796.58
30min1416092-416092100.00196.692.48100.6697.332.47
2402268-40226896.67997.32
3404844-40484497.29897.94
4405823-40582397.53398.18
5399091-39909195.91596.56
6385720-38572092.70293.33
45min1415167-41516799.77996.911.61100.6097.721.61
2401705-40170596.54397.35
3404413-40441397.19498.00
4402838-40283896.81697.63
5398281-39828195.72196.52
6396987-39698795.41096.19
60min1413384-41338499.35097.071.32100.3498.041.32
2401720-40172096.54797.51
3402943-40294396.84197.81
4406322-40632297.65398.63
5399127-39912795.92496.89
6399929-39992996.11797.06
极限1412299-41229999.09097.401.66100.2498.531.64
2399344-39934495.97697.10
3403168-40316896.89598.02
4402616-40261696.76297.90
5399337-39933795.97497.10
6414919-41491999.719100.82
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