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%
111.803693223692453692763687963691193691520.06
211.793690203684203687200.12
单位质量响应值RSD%判断
31284.0731273.960.03数据可信
中间条件12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%
5min1314985-31498576.00985.666.4776.0185.666.47
2377409-37740991.07291.07
3371970-37197089.76089.76
4342598-34259882.67282.67
5359454-35945486.74086.74
6363340-36334087.67787.68
10min1353955-35395585.41395.035.2885.5495.185.28
2408677-40867798.61798.77
3408858-40885898.66198.81
4396730-39673095.73595.87
5404000-40400097.48997.63
6390749-39074994.29194.44
15min1368000-36800088.80297.224.5089.0797.524.51
2416223-416223100.438100.75
3416824-416824100.583100.90
4405354-40535497.81698.11
5409475-40947598.81099.12
6401340-40134096.84797.15
20min1378231-37823191.27198.383.8091.6998.843.81
2419585-419585101.250101.73
3419972-419972101.343101.82
4407387-40738798.30698.77
5413914-41391499.881100.35
6407008-40700898.21598.68
30min1391479-39147994.46799.532.9195.04100.152.91
2420409-420409101.449102.10
3425797-425797102.749103.40
4408876-40887698.66599.29
5416877-416877100.596101.23
6411210-41121099.22999.86
45min1403319-40331997.325100.282.2498.05101.072.26
2421246-421246101.650102.47
3429690-429690103.688104.51
4409021-40902198.70099.49
5417012-417012100.629101.43
6413021-41302199.666100.46
60min1408058-40805898.468100.661.9699.36101.621.98
2420752-420752101.531102.52
3430493-430493103.882104.88
4409396-40939698.79199.74
5416700-416700100.554101.53
6417485-417485100.743101.70
极限1412844-41284499.623100.521.72100.68101.641.72
2420486-420486101.467102.63
3428395-428395103.376104.54
4408069-40806998.47199.59
5416510-416510100.508101.65
6412976-41297699.655100.78
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%
111.803691153685193680403688543688053686670.12
211.793694143682893688520.22
单位质量响应值RSD%判断
31242.9731285.160.10数据可信
中间条件12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%
5min1378527-37852791.38687.789.0091.3987.789.00
2324048-32404878.23378.23
3402520-40252097.17897.18
4354182-35418285.50885.51
5392255-39225594.70094.70
6329975-32997579.66479.66
10min1396226-39622695.65994.625.6995.8194.775.70
2360085-36008586.93387.06
3418375-418375101.006101.17
4389632-38963294.06794.21
5412871-41287199.67799.84
6374357-37435790.37990.51
15min1402718-40271897.22696.564.4497.5496.864.44
2376862-37686290.98491.26
3422979-422979102.118102.45
4398144-39814496.12296.42
5415242-415242100.250100.57
6383769-38376992.65192.93
20min1404453-40445397.64597.393.8398.1297.853.84
2384147-38414792.74393.17
3423652-423652102.280102.78
4402707-40270797.22397.68
5416937-416937100.659101.15
6388366-38836693.76194.20
30min1406444-40644498.12698.333.1198.7698.963.12
2392814-39281494.83595.42
3426110-426110102.873103.54
4405876-40587697.98898.61
5416981-416981100.669101.33
6395457-39545795.47396.07
45min1407195-40719598.30798.992.4299.1199.782.44
2402323-40232397.13197.87
3427004-427004103.089103.93
4407974-40797498.49599.28
5415636-415636100.345101.17
6400037-40003796.57997.33
60min1405378-40537897.86899.072.2098.83100.032.22
2406106-40610698.04498.95
3426153-426153102.884103.90
4408659-40865998.66099.61
5415002-415002100.192101.19
6400857-40085796.77797.69
极限1404441-40444197.64299.042.2698.77100.162.27
2409479-40947998.85899.92
3425997-425997102.846104.03
4407123-40712398.29099.40
5414859-414859100.157101.32
6399597-39959796.47397.55
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%
111.803693023687203677623691463687493687360.17
211.793694983686493690740.17
单位质量响应值RSD%判断
31248.8131303.990.13数据可信
中间条件12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%
5min1348724-34872484.15788.575.4184.1688.575.40
2384089-38408992.69292.69
3340262-34026282.11582.12
4385629-38562993.06493.06
5382431-38243192.29292.29
6360841-36084187.08287.08
10min1384383-38438392.76394.873.4492.9095.023.45
2402035-40203597.02397.18
3376830-37683090.94091.08
4408189-40818998.50898.66
5405140-40514097.77297.93
6382095-38209592.21192.36
15min1390722-39072294.29396.472.6794.5996.782.67
2407678-40767898.38598.70
3389792-38979294.06894.36
4412135-41213599.46099.78
5408317-40831798.53998.86
6389926-38992694.10194.40
20min1397527-39752795.93597.322.1696.3997.782.17
2408562-40856298.59899.08
3393889-39388995.05795.50
4414040-41404099.920100.41
5410216-41021698.99799.48
6395263-39526395.38995.84
30min1400265-40026596.59698.181.6897.2198.811.69
2412927-41292799.651100.30
3400500-40050096.65297.26
4413833-41383399.870100.52
5412225-41222599.482100.13
6401129-40112996.80497.42
45min1408048-40804898.47498.871.2499.2599.661.26
2413988-41398899.907100.72
3405255-40525597.80098.56
4413557-41355799.803100.62
5414528-414528100.038100.85
6402658-40265897.17397.95
60min1409709-40970998.87598.950.8699.8199.900.88
2413577-41357799.808100.79
3407334-40733498.30299.23
4412128-41212899.459100.44
5412730-41273099.604100.58
6404524-40452497.62498.56
极限1388640-38864093.79098.242.4694.8999.362.45
2413486-41348699.786100.93
3410255-41025599.007100.10
4413360-41336099.756100.91
5414088-41408899.932101.08
6402587-40258797.15698.26
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%
111.803692563696623682873692063688393690500.15
211.793680103681873680980.04
单位质量响应值RSD%判断
31275.4231221.200.13数据可信
中间条件12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%
5min1382580-38258092.41191.105.0592.4191.105.05
2357781-35778186.42186.42
3360255-36025587.01887.02
4364696-36469688.09188.09
5402716-40271697.27597.27
6394794-39479495.36195.36
10min1404120-40412097.61497.511.6897.7797.661.68
2391897-39189794.66194.81
3404964-40496497.81897.96
4401043-40104396.87097.02
5410880-41088099.24799.41
6409123-40912398.82298.98
15min1405390-40539097.92098.811.5098.2499.131.50
2399971-39997196.61296.91
3409876-40987699.00499.31
4408962-40896298.78399.09
5417891-417891100.940101.27
6412469-41246999.63099.95
20min1405620-40562097.97699.261.5398.4699.741.53
2402391-40239197.19697.66
3412327-41232799.596100.07
4412552-41255299.650100.12
5420372-420372101.539102.04
6412351-41235199.602100.09
30min1406512-40651298.191100.472.7298.83101.122.71
2406123-40612398.09898.72
3411546-41154699.407100.05
4420167-420167101.490102.13
5436273-436273105.380106.05
6415056-415056100.255100.91
45min1406979-40697998.304100.191.8699.11101.001.86
2408056-40805698.56499.35
3411558-41155899.410100.22
4424128-424128102.447103.25
5424380-424380102.507103.35
6413559-41355999.894100.72
60min1405973-40597398.061100.051.9399.03101.031.93
2407848-40784898.51499.47
3411075-41107599.294100.26
4424964-424964102.649103.63
5423173-423173102.216103.23
6412294-41229499.588100.58
极限1405564-40556497.96399.852.0399.10100.992.03
2406507-40650798.19099.31
3410943-41094399.262100.40
4425462-425462102.769103.92
5422151-422151101.969103.15
6409522-40952298.919100.07
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%
111.803674283668433671893674033669893671700.07
211.793677203671813674500.11
单位质量响应值RSD%判断
31116.1031166.240.12数据可信
中间条件12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%
5min1348423-34842384.45084.418.6684.4584.418.66
2362063-36206387.75687.76
3338443-33844382.03182.03
4385913-38591393.53793.54
5296043-29604371.75471.75
6358641-35864186.92686.93
10min1384227-38422793.12892.376.8993.2792.526.90
2400775-40077597.13997.29
3382454-38245492.69892.83
4396829-39682996.18296.34
5329511-32951179.86679.99
6392921-39292195.23595.38
15min1396858-39685896.18994.745.6196.4995.045.62
2405847-40584798.36898.68
3394300-39430095.56995.86
4399321-39932196.78697.10
5346932-34693284.08884.34
6402098-40209897.45997.76
20min1404006-40400697.92296.094.7398.3896.554.74
2407181-40718198.69199.16
3400692-40069297.11997.57
4401807-40180797.38997.87
5358600-35860086.91787.31
6406471-40647198.51998.99
30min1409297-40929799.20497.962.8699.8298.572.87
2408206-40820698.94099.58
3409349-40934999.21799.83
4404885-40488598.13598.77
5381141-38114192.38092.92
6412139-41213999.893100.52
45min1416003-416003100.83098.771.83101.6199.541.84
2407894-40789498.86499.67
3410871-41087199.586100.36
4404616-40461698.07098.87
5394442-39444295.60496.30
6411113-41111399.644100.44
60min1417525-417525101.19999.471.10102.15100.411.10
2409219-40921999.185100.15
3412630-412630100.012100.96
4404983-40498398.15999.13
5406647-40664798.56299.41
6411280-41128099.685100.65
极限1417967-417967101.30699.401.27102.43100.511.25
2407870-40787098.85899.99
3411046-41104699.628100.74
4402019-40201997.44098.57
5411173-41117399.659100.67
6410666-41066699.536100.67
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