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%
111.913799623798343799153796793794053797590.06
211.913812103806263809180.11
单位质量响应值RSD%判断
31885.7331983.040.22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%
5min1391154-39115492.84294.642.6292.8494.642.62
2388773-38877392.27792.28
3399658-39965894.86094.86
4407002-40700296.60496.60
5414734-41473498.43998.44
6390943-39094392.79292.79
10min1407615-40761596.74997.402.9896.9097.562.98
2412741-41274197.96698.12
3413934-41393498.24998.41
4412391-41239197.88398.04
5426462-426462101.222101.39
6388980-38898092.32692.48
15min1408620-40862096.98898.501.4497.3098.821.44
2424535-424535100.765101.08
3411225-41122597.60697.93
4413338-41333898.10798.43
5419780-41978099.63699.97
6412386-41238697.88198.19
20min1407318-40731896.67998.141.2197.1698.621.21
2417868-41786899.18399.67
3411746-41174697.73098.21
4412088-41208897.81198.30
5420948-42094899.914100.41
6410891-41089197.52798.00
30min1409347-40934797.16097.540.6897.8098.190.68
2409411-40941197.17597.83
3407604-40760496.74697.39
4414735-41473598.43999.09
5413810-41381098.21998.88
6410876-41087697.52398.16
45min1403464-40346495.76497.331.2196.5698.141.21
2408311-40831196.91497.73
3408910-40891097.05697.87
4409695-40969597.24398.06
5418569-41856999.349100.18
6411470-41147097.66498.46
60min1406395-40639596.45997.340.8697.4298.310.86
2407340-40734096.68497.66
3411005-41100597.55498.52
4411045-41104597.56398.54
5416121-41612198.76899.76
6408753-40875397.01997.98
极限1403041-40304195.66396.970.8896.7898.100.87
2407163-40716396.64297.78
3408455-40845596.94898.08
4412351-41235197.87399.01
5407722-40772296.77497.93
6412583-41258397.92899.05
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%
111.913831803831053833993833063827693831520.07
211.913770523768003769260.05
单位质量响应值RSD%判断
32170.6131647.861.16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%
5min1393976-39397693.59292.404.0993.5992.404.09
2362191-36219186.04186.04
3404692-40469296.13796.14
4388703-38870392.33992.34
5403289-40328995.80495.80
6380835-38083590.47090.47
10min1400193-40019395.06895.832.3595.2295.982.35
2392752-39275293.30193.44
3410074-41007497.41697.58
4413275-41327598.17698.33
5411435-41143597.73997.90
6392562-39256293.25693.41
15min1413063-41306398.12696.743.2098.4497.053.20
2394111-39411193.62493.92
3420539-42053999.902100.22
4419751-41975199.715100.03
5406221-40622196.50096.82
6389742-38974292.58692.89
20min1401379-40137995.35096.222.5195.8396.692.51
2394632-39463293.74794.20
3411697-41169797.80198.29
4415593-41559398.72799.21
5414218-41421898.40098.88
6392702-39270293.28993.75
30min1397564-39756494.44495.182.2495.0895.822.24
2393833-39383393.55894.17
3398445-39844594.65395.31
4414530-41453098.47499.12
5408349-40834997.00697.65
6391281-39128192.95193.57
45min1402206-40220695.54795.722.7296.3496.512.72
2394540-39454093.72694.49
3410258-41025897.45998.27
4415975-41597598.81899.63
5408188-40818896.96897.78
6386344-38634491.77992.55
60min1398873-39887394.75595.672.1995.7196.622.19
2394216-39421693.64994.57
3406304-40630496.52097.49
4413593-41359398.25299.23
5410765-41076597.58098.55
6392508-39250893.24394.17
极限1393992-39399293.59595.582.4694.7196.692.45
2396021-39602194.07795.16
3407016-40701696.68997.82
4411117-41111797.66498.80
5414736-41473698.52399.66
6391190-39119092.93094.01
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