盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.303940693937133929033935843932923935120.12
212.273930893928083929480.06
单位质量响应值RSD%判断
31992.8532025.100.08数据可信
长期6月-供试品溶液-2023120221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%
2min1311168-31116873.68575.2215.0473.6875.2215.04
2333261-33326178.91678.92
3346783-34678382.11882.12
4372274-37227488.15588.15
5232635-23263555.08855.09
6309896-30989673.38473.38
5min1394981-39498193.53293.724.2193.5393.724.21
2408835-40883596.81296.81
3409885-40988597.06197.06
4404427-40442795.76895.77
5365520-36552086.55586.56
6390888-39088892.56292.56
10min1394879-39487993.50894.322.9593.5194.322.95
2409110-40911096.87796.88
3413927-41392798.01898.02
4395356-39535693.62093.62
5395540-39554093.66493.66
6381018-38101890.22590.23
15min1392796-39279693.01496.262.2693.0196.262.27
2414139-41413998.06898.07
3413190-41319097.84497.84
4409673-40967397.01197.01
5397104-39710494.03494.03
6412149-41214997.59797.60
20min1404027-40402795.67498.211.4695.6798.211.47
2412461-41246197.67197.67
3416904-41690498.72398.72
4421821-42182199.88799.89
5415930-41593098.49298.49
6417339-41733998.82698.83
30min1402735-40273595.36898.732.3395.3798.732.33
2414745-41474598.21298.21
3417515-41751598.86898.87
4422350-422350100.013100.01
5431618-431618102.207102.21
6412682-41268297.72397.72
45min1405003-40500395.90598.912.0295.9098.912.02
2418513-41851399.10499.10
3414092-41409298.05798.06
4425623-425623100.788100.79
5428175-428175101.392101.39
6414871-41487198.24298.24
60min1406233-40623396.19699.091.6296.2099.091.62
2419610-41961099.36499.36
3418296-41829699.05399.05
4425046-425046100.651100.65
5424237-424237100.460100.46
6417214-41721498.79698.80
极限1404310-40431095.74199.041.9395.7499.041.93
2417469-41746998.85798.86
3419189-41918999.26499.26
4424455-424455100.511100.51
5427602-427602101.256101.26
6416476-41647698.62298.62
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.303925323923643922703926113941213927800.20
212.273912263935523923890.42
单位质量响应值RSD%判断
31933.3331979.540.11数据可信
长期6月-供试品溶液-2023120521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%
2min1338863-33886380.37574.836.0080.3774.836.00
2320664-32066476.05876.06
3329691-32969178.19978.20
4291884-29188469.23269.23
5294256-29425669.79569.79
6317577-31757775.32675.33
5min1397534-39753494.29193.432.2394.2993.442.23
2381240-38124090.42690.43
3402892-40289295.56295.56
4397608-39760894.30994.31
5384722-38472291.25291.25
6399543-39954394.76894.77
10min1399516-39951694.76194.371.1494.7694.381.14
2394114-39411493.48093.48
3400804-40080495.06795.07
4404510-40451095.94695.95
5392672-39267293.13893.14
6395683-39568393.85293.85
15min1403326-40332695.66594.512.2395.6694.512.23
2387049-38704991.80491.80
3399038-39903894.64894.65
4411289-41128997.55497.55
5389924-38992492.48692.49
6400099-40009994.89994.90
20min1400493-40049394.99394.482.8994.9994.482.89
2387170-38717091.83391.83
3409034-40903497.01997.02
4412188-41218897.76797.77
5383374-38337490.93290.93
6397761-39776194.34594.34
30min1404863-40486396.02994.482.8496.0394.482.84
2377743-37774389.59789.60
3409767-40976797.19397.19
4403126-40312695.61795.62
5394376-39437693.54293.54
6399984-39998494.87294.87
45min1404682-40468295.98696.171.8795.9996.171.87
2393714-39371493.38593.38
3411816-41181697.67997.68
4415060-41506098.44898.45
5401629-40162995.26295.26
6405786-40578696.24896.25
60min1404625-40462595.97395.511.9995.9795.511.99
2388104-38810492.05492.05
3405056-40505696.07596.08
4412126-41212697.75297.75
5405191-40519196.10796.11
6400947-40094795.10195.10
极限1396922-39692294.14696.072.5394.1596.072.53
2392901-39290193.19293.19
3417767-41776799.09099.09
4416461-41646198.78098.78
5400852-40085295.07895.08
6405354-40535496.14696.15
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.303914703916023918703927323912873917920.15
212.273921153923103922120.04
单位质量响应值RSD%判断
31853.0131965.120.25数据可信
长期6月-供试品溶液-2023120621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%
2min1315512-31551274.94878.2110.0274.9578.2110.01
2328242-32824277.97177.97
3304712-30471272.38272.38
4366738-36673887.11687.12
5370354-37035487.97587.97
6289949-28994968.87568.88
5min1396084-39608494.08795.132.0894.0995.132.08
2400001-40000195.01795.02
3404520-40452096.09196.09
4413714-41371498.27598.27
5399547-39954794.90994.91
6388939-38893992.39092.39
10min1399667-39966794.93896.542.5994.9496.542.59
2399437-39943794.88394.88
3408914-40891497.13497.13
4425065-425065100.971100.97
5408834-40883497.11597.12
6396471-39647194.17994.18
15min1394657-39465793.74896.563.8393.7596.563.83
2403898-40389895.94395.94
3417449-41744999.16299.16
4427984-427984101.664101.66
5410049-41004997.40497.40
6384845-38484591.41791.42
20min1390515-39051592.76496.873.3592.7696.873.35
2405950-40595096.43096.43
3420639-42063999.92099.92
4426061-426061101.208101.21
5407341-40734196.76196.76
6396362-39636294.15394.15
30min1403579-40357995.86797.443.0295.8797.443.02
2406151-40615196.47896.48
3420000-42000099.76899.77
4429566-429566102.040102.04
5406398-40639896.53796.54
6395471-39547193.94193.94
45min1403349-40334995.81397.323.4195.8197.323.41
2407446-40744696.78696.79
3421711-421711100.174100.17
4431236-431236102.437102.44
5395195-39519593.87693.88
6399122-39912294.80894.81
60min1406955-40695596.66997.353.8096.6797.353.80
2398114-39811494.56994.57
3423742-423742100.657100.66
4431516-431516102.503102.50
5408638-40863897.06997.07
6389896-38989692.61792.62
极限1399207-39920794.82997.062.8194.8397.062.81
2402142-40214295.52695.53
3419023-41902399.53699.54
4424764-424764100.900100.90
5410243-41024397.45097.45
6396224-39622494.12094.12
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.303947143950553951183951083944713948930.08
212.273909993910423910200.01
单位质量响应值RSD%判断
32105.1231867.970.53数据可信
长期6月-供试品溶液-2205008609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%
2min1198997-19899747.15645.1815.0847.1645.1815.08
2190877-19087745.23245.23
3143952-14395234.11234.11
4180025-18002542.66042.66
5198202-19820246.96846.97
6231990-23199054.97554.97
5min1367506-36750687.08886.793.5587.0986.793.55
2379542-37954289.94089.94
3355869-35586984.33084.33
4382072-38207290.53990.54
5348946-34894682.69082.69
6363555-36355586.15286.15
10min1384152-38415291.03292.672.8491.0392.672.84
2404342-40434295.81795.82
3396760-39676094.02094.02
4401051-40105195.03795.04
5382951-38295190.74890.75
6377124-37712489.36789.37
15min1407223-40722396.49994.144.8696.5094.144.86
2416961-41696198.80798.81
3364020-36402086.26286.26
4411778-41177897.57997.58
5392700-39270093.05893.06
6391019-39101992.66092.66
20min1409941-40994197.14495.262.6197.1495.262.61
2410751-41075197.33697.34
3403389-40338995.59195.59
4409696-40969697.08697.09
5386539-38653991.59891.60
6391643-39164392.80892.81
30min1414169-41416998.14595.693.4198.1595.693.41
2421107-42110799.79099.79
3402432-40243295.36495.36
4406138-40613896.24296.24
5381682-38168290.44790.45
6397359-39735994.16294.16
45min1411956-41195697.62196.572.2597.6296.572.25
2420193-42019399.57399.57
3398673-39867394.47394.47
4414082-41408298.12598.12
5402154-40215495.29895.30
6398162-39816294.35294.35
60min1400860-40086094.99295.322.8894.9995.322.88
2420851-42085199.72999.73
3402943-40294395.48595.49
4408194-40819496.73096.73
5389223-38922392.23492.23
6391466-39146692.76692.77
极限1397174-39717494.11894.963.9194.1294.963.91
2419882-41988299.49999.50
3407191-40719196.49296.49
4410131-41013197.18997.19
5395322-39532293.67993.68
6374573-37457388.76288.76
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