枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)1.0补液体积(ml)0
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200
标示量(mg)50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%
114.164816584816614817944816444825524818620.09
214.074812264812304812280.01
单位质量响应值RSD%判断
34029.8034202.420.36数据可信
供试品溶液-C090402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%
2min1428866-42886679.56577.433.1479.5777.433.14
2421117-42111778.12778.13
3414695-41469576.93676.94
4431546-43154680.06280.06
5395582-39558273.39073.39
6412415-41241576.51376.51
5min1531027-53102798.51897.840.7498.6197.930.74
2525623-52562397.51697.60
3520997-52099796.65896.74
4527221-52722197.81297.90
5531494-53149498.60598.69
6528020-52802097.96198.05
10min1533430-53343098.96498.700.5799.1698.900.57
2529195-52919598.17998.37
3528335-52833598.01998.21
4532046-53204698.70798.91
5536704-53670499.57299.76
6532416-53241698.77698.97
15min1532827-53282798.85298.620.6699.1698.930.66
2527349-52734997.83698.14
3528469-52846998.04498.35
4530887-53088798.49298.80
5537044-53704499.63599.94
6532959-53295998.87799.18
20min1531651-53165198.63498.091.2599.0598.511.24
2526782-52678297.73198.14
3527451-52745197.85598.27
4517353-51735395.98296.40
5536081-53608199.45699.87
6533047-53304798.89399.31
30min1533885-53388599.04998.790.7299.5899.320.72
2528440-52844098.03898.56
3528513-52851398.05298.57
4531155-53115598.54299.07
5538003-53800399.813100.34
6535073-53507399.26999.79
45min1533352-53335298.95098.680.7999.5999.320.79
2527801-52780197.92098.55
3527255-52725597.81998.45
4531258-53125898.56199.19
5538539-53853999.912100.55
6533265-53326598.93499.57
极限1532112-53211298.72098.820.5499.4799.560.53
2530749-53074998.46799.21
3530488-53048898.41899.16
4531725-53172598.64899.39
5538188-53818899.847100.59
6532563-53256398.80399.55
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)1.0补液体积(ml)0
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200
标示量(mg)50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%
114.164825464818594817044818344817664819420.08
214.074805744801144803440.07
单位质量响应值RSD%判断
34035.4534139.590.22数据可信
供试品溶液-C090402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%
2min1385325-38532571.54775.224.7571.5575.224.74
2398285-39828573.95373.95
3415865-41586577.21777.22
4436909-43690981.12581.12
5388410-38841072.12072.12
6405879-40587975.36375.36
5min1524888-52488897.46197.641.8197.5497.721.81
2520905-52090596.72196.80
3517170-51717096.02896.11
4543550-543550100.926101.02
5520272-52027296.60496.68
6528200-52820098.07698.16
10min1531134-53113498.62098.621.7198.8198.821.71
2525446-52544697.56497.75
3523192-52319297.14697.34
4546984-546984101.564101.77
5524588-52458897.40597.59
6535517-53551799.43499.63
15min1531131-53113198.62098.571.6998.9298.871.69
2526348-52634897.73298.03
3522448-52244897.00897.31
4547709-547709101.698102.01
5525854-52585497.64097.94
6531539-53153998.69699.00
20min1531129-53112998.62098.721.5899.0399.141.58
2527095-52709597.87198.28
3523259-52325997.15897.57
4546255-546255101.428101.86
5526553-52655397.77098.17
6535875-53587599.50199.91
30min1530428-53042898.48998.621.6699.0199.141.66
2524539-52453997.39697.91
3523916-52391697.28097.80
4546567-546567101.486102.03
5525583-52558397.59098.10
6535866-53586699.499100.02
45min1531910-53191098.76598.751.8599.3999.381.85
2524220-52422097.33797.96
3523865-52386597.27197.90
4549121-549121101.960102.61
5525551-52555197.58498.21
6536410-53641099.600100.23
极限1531390-53139098.66898.811.7899.4099.551.78
2526314-52631497.72698.46
3522835-52283597.08097.81
4548573-548573101.859102.63
5526693-52669397.79698.53
6537176-53717699.742100.49
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)1.0补液体积(ml)0
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200
标示量(mg)50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%
114.164802884798824810614801584801184803010.10
214.074809394802664806020.10
单位质量响应值RSD%判断
33919.5634157.920.50数据可信
供试品溶液-C090402批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1443580-44358082.48278.544.2582.4878.544.25
2431597-43159780.25480.25
3433936-43393680.68980.69
4394371-39437173.33273.33
5420772-42077278.24178.24
6410014-41001476.24176.24
5min1505691-50569194.03295.471.1294.1295.561.12
2519711-51971196.63996.73
3508318-50831894.52094.61
4518925-51892596.49396.57
5512022-51202295.20995.30
6515882-51588295.92796.01
10min1525959-52595997.80198.401.2898.0098.591.28
2520970-52097096.87397.07
3534354-53435499.36299.56
4537825-537825100.007100.20
5523180-52318097.28497.48
6532674-53267499.04999.24
15min1530920-53092098.72398.311.0999.0398.611.08
2525015-52501597.62597.93
3525341-52534197.68697.99
4538421-538421100.118100.42
5522541-52254197.16597.47
6529935-52993598.54098.84
20min1529691-52969198.49498.350.9398.9198.760.93
2522940-52294097.23997.65
3528244-52824498.22598.64
4536969-53696999.848100.26
5524960-52496097.61598.02
6530732-53073298.68899.10
30min1527329-52732998.05598.160.9198.5898.680.91
2523138-52313897.27697.80
3526038-52603897.81598.34
4535554-53555499.585100.11
5523748-52374897.38997.91
6531469-53146998.82599.35
45min1529918-52991898.53798.400.8899.1799.030.87
2524242-52424297.48198.11
3531758-53175898.87999.51
4536096-53609699.685100.32
5523976-52397697.43298.06
6529057-52905798.37799.01
极限1528870-52887098.34298.271.0199.0899.011.01
2523327-52332797.31198.05
3525522-52552297.71998.46
4537463-53746399.940100.68
5524392-52439297.50998.24
6531474-53147498.82699.57
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)1.0补液体积(ml)0
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200
标示量(mg)50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%
114.164821304822694822044811184823234820090.11
214.074815284815384815330.01
单位质量响应值RSD%判断
34040.1834224.090.39数据可信
供试品溶液-C090402批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1426047-42604779.00574.217.4479.0174.217.44
2343656-34365663.72763.73
3403695-40369574.86074.86
4421701-42170178.19978.20
5397159-39715973.64873.65
6408854-40885475.81775.82
5min1520552-52055296.53096.531.3796.6296.611.37
2513657-51365795.25195.32
3522021-52202196.80296.89
4523372-52337297.05397.14
5531643-53164398.58698.67
6512053-51205394.95495.04
10min1519793-51979396.38996.931.1996.5897.121.19
2520833-52083396.58296.76
3523676-52367697.10997.30
4524663-52466397.29297.49
5532958-53295898.83099.02
6514384-51438495.38695.58
15min1520626-52062696.54396.881.2496.8597.181.24
2519582-51958296.35096.63
3522471-52247196.88697.18
4525649-52564997.47597.78
5532896-53289698.81999.12
6513572-51357295.23595.53
20min1511779-51177994.90396.661.6495.3197.061.63
2520425-52042596.50696.90
3521207-52120796.65197.06
4527241-52724197.77098.18
5534026-53402699.02899.44
6512761-51276195.08595.49
30min1521620-52162096.72896.861.1497.2497.371.14
2519816-51981696.39396.89
3520866-52086696.58897.10
4524988-52498897.35297.87
5532202-53220298.69099.21
6514506-51450695.40995.92
45min1521216-52121696.65396.881.2597.2897.501.25
2518942-51894296.23196.84
3520733-52073396.56397.18
4525417-52541797.43298.06
5533739-53373998.97599.61
6514727-51472795.45096.06
极限1523468-52346897.07097.021.4897.8097.751.48
2515222-51522295.54196.25
3523207-52320797.02297.75
4529535-52953598.19698.93
5533802-53380298.98799.73
6514093-51409395.33296.05
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