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%
111.913784623780443782993780173779433781530.06
211.913831483834663833070.06
单位质量响应值RSD%判断
31750.8832183.630.96数据可信
供试品溶液-2024072521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%
5min1403180-40318095.60295.091.0995.6095.091.09
2401688-40168895.24895.25
3408375-40837596.83496.83
4398106-39810694.39994.40
5397922-39792294.35594.36
6396835-39683594.09894.10
10min1416572-41657298.77898.100.4398.9498.260.43
2412955-41295597.92098.08
3414832-41483298.36598.53
4411692-41169297.62197.78
5412506-41250697.81497.97
6413687-41368798.09498.25
15min1415294-41529498.47596.723.5998.8097.043.58
2410588-41058897.35997.68
3415265-41526598.46898.79
4378222-37822289.68490.00
5414334-41433498.24798.57
6413610-41361098.07598.40
20min1416002-41600298.64398.181.8899.1398.661.87
2404607-40460795.94196.42
3427715-427715101.420101.91
4409808-40980897.17497.64
5413850-41385098.13298.62
6412370-41237097.78198.27
30min1414945-41494598.39297.560.7899.0498.210.78
2410035-41003597.22897.87
3414156-41415698.20598.86
4410481-41048197.33397.96
5406307-40630796.34496.99
6412756-41275697.87398.52
45min1428672-428672101.64797.921.91102.4698.721.90
2407575-40757596.64497.45
3410280-41028097.28698.11
4408136-40813696.77797.57
5411298-41129897.52798.34
6411651-41165197.61198.42
60min1410406-41040697.31697.420.5798.3098.390.57
2407329-40732996.58697.55
3414046-41404698.17999.16
4409978-40997897.21498.17
5410725-41072597.39198.36
6412641-41264197.84698.82
极限1413432-41343298.03397.130.8799.1898.270.87
2407044-40704496.51897.65
3410313-41031397.29498.44
4404037-40403795.80596.92
5410274-41027497.28498.42
6412731-41273197.86799.00
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%
111.913775003782753782903778303780963779980.09
211.913777113779793778450.06
单位质量响应值RSD%判断
31737.8731725.020.03数据可信
供试品溶液-2024072521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%
5min1389317-38931792.99793.753.2993.0093.753.29
2402729-40272996.20096.20
3409036-40903697.70797.71
4395337-39533794.43594.43
5372874-37287489.06989.07
6385522-38552292.09092.09
10min1401834-40183495.98796.892.8896.1497.042.88
2420859-420859100.531100.69
3412501-41250198.53598.70
4410657-41065798.09498.25
5387355-38735592.52892.68
6400410-40041095.64795.80
15min1403089-40308996.28697.522.7396.6097.842.73
2422211-422211100.854101.18
3418792-418792100.037100.36
4410892-41089298.15098.47
5392974-39297493.87094.17
6401538-40153895.91696.23
20min1399566-39956695.44597.453.7895.9297.933.77
2435737-435737104.085104.58
3410390-41039098.03098.52
4410411-41041198.03598.52
5391454-39145493.50793.97
6400233-40023395.60496.08
30min1401557-40155795.92197.222.7296.5697.862.72
2421593-421593100.707101.38
3415482-41548299.24799.90
4412326-41232698.49399.14
5393956-39395694.10594.72
6397081-39708194.85195.48
45min1399649-39964995.46597.092.9896.2697.902.98
2425595-425595101.663102.50
3414510-41451099.01599.84
4407930-40793097.44398.25
5393028-39302893.88394.65
6398081-39808195.09095.88
60min1398928-39892895.29397.052.5496.2598.022.54
2419906-419906100.304101.31
3414466-41446699.00499.99
4411528-41152898.30299.28
5395570-39557094.49095.42
6397288-39728894.90195.85
极限1395419-39541994.45496.672.8395.5797.802.83
2421593-421593100.707101.88
3411733-41173398.35199.50
4410186-41018697.98299.12
5395090-39509094.37695.46
6394233-39423394.17195.28
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%
111.913782563788183783093789243788373786290.09
211.913780393776673778530.07
单位质量响应值RSD%判断
31790.8531725.690.15数据可信
供试品溶液-2024072522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%
5min1387470-38747092.47796.693.0892.4896.693.08
2415562-41556299.18299.18
3399980-39998095.46395.46
4401711-40171195.87695.88
5422783-422783100.906100.91
6403292-40329296.25496.25
10min1399454-39945495.33899.522.4095.4999.682.40
2421331-421331100.559100.72
3414082-41408298.82998.99
4415386-41538699.14099.30
5427466-427466102.023102.19
6424064-424064101.211101.37
15min1400075-40007595.48698.512.2995.8098.842.29
2415340-41534099.12999.46
3414054-41405498.82299.15
4413148-41314898.60698.93
5427953-427953102.140102.48
6405997-40599796.89997.23
20min1398615-39861595.13797.533.1095.6198.023.09
2417726-41772699.699100.20
3410034-41003497.86398.35
4395691-39569194.44094.93
5428434-428434102.254102.76
6401364-40136495.79496.28
30min1401385-40138595.79999.072.5796.4399.732.57
2428648-428648102.305102.97
3413728-41372898.74499.40
4416854-41685499.491100.14
5424774-424774101.381102.06
6405197-40519796.70897.36
45min1402397-40239796.04098.712.3296.8399.532.32
2417154-41715499.562100.40
3413524-41352498.69699.51
4417626-41762699.675100.49
5427611-427611102.058102.91
6403154-40315496.22197.03
60min1398952-39895295.21898.923.0996.1799.903.08
2415294-41529499.118100.12
3411572-41157298.23099.21
4432294-432294103.176104.15
5425487-425487101.551102.57
6403070-40307096.20197.17
极限1399307-39930795.30398.112.2096.4199.262.21
2416203-41620399.335100.50
3411956-41195698.32299.47
4412079-41207998.35199.50
5424143-424143101.230102.42
6402647-40264796.10097.23
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