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对照品来源自制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%
112.097697307699627705477701487697667700310.05
212.187671157680337675740.09
单位质量响应值RSD%判断
63691.5663019.210.76数据可信
供试品溶液-2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1298471-29847135.71033.8631.4635.7133.8631.45
2395601-39560147.33047.33
3316825-31682537.90637.91
4123261-12326114.74714.75
5277999-27799933.26033.26
6285760-28576034.18934.19
10min1362584-36258443.38040.5226.2743.4440.5726.28
2438429-43842952.45452.53
3378788-37878845.31945.38
4173418-17341820.74820.77
5346926-34692641.50741.56
6331744-33174439.69039.75
15min1404334-40433448.37545.2423.9048.5145.3623.91
2474734-47473456.79856.96
3420878-42087850.35550.49
4209302-20930225.04125.10
5394973-39497347.25547.38
6364357-36435743.59243.72
20min1442882-44288252.98749.0021.5053.2049.2021.52
2497601-49760159.53459.79
3451504-45150454.01954.24
4244161-24416129.21229.31
5430283-43028351.48051.68
6390924-39092446.77146.97
30min1492131-49213158.87954.7718.1859.1855.0518.22
2539407-53940764.53664.90
3495237-49523759.25159.56
4302838-30283836.23236.38
5484621-48462157.98158.27
6432349-43234951.72752.00
45min1540574-54057464.67560.7314.2165.0761.1014.26
2575065-57506568.80269.27
3537824-53782464.34664.76
4374438-37443844.79845.01
5537802-53780264.34464.73
6479694-47969457.39157.75
60min1569143-56914368.09364.8111.8768.6065.2811.93
2601129-60112971.92072.50
3566101-56610167.72968.25
4423771-42377150.70150.99
5575471-57547168.85069.34
6514680-51468061.57762.03
极限1600762-60076271.87670.288.3172.5070.868.39
2630812-63081275.47176.17
3612762-61276273.31273.94
4500852-50085259.92360.29
5618598-61859874.01074.62
6560641-56064167.07667.63
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对照品来源自制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%
112.097693947686117699997695477695377694180.07
212.187717117721217719160.04
单位质量响应值RSD%判断
63640.8663375.700.30数据可信
供试品溶液-2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1160065-16006519.10436.8739.9619.1036.8739.96
2317116-31711637.84837.85
3399002-39900247.62147.62
4408971-40897148.81148.81
5415573-41557349.59949.60
6152649-15264918.21918.22
10min1222183-22218326.51843.1533.7026.5543.2133.71
2364096-36409643.45543.52
3453514-45351454.12754.21
4460466-46046654.95755.04
5466806-46680655.71455.80
6202004-20200424.10924.14
15min1266648-26664831.82547.7229.5631.9047.8629.58
2406708-40670848.54148.68
3491167-49116758.62158.79
4493669-49366958.92059.09
5499228-49922859.58359.76
6241606-24160628.83628.91
20min1320998-32099838.31151.8525.6338.4452.0625.67
2444835-44483553.09153.31
3519917-51991762.05362.32
4521491-52149162.24062.51
5525509-52550962.72062.99
6273751-27375132.67232.79
30min1412498-41249849.23258.1019.9649.4258.3920.02
2499832-49983259.65559.96
3559412-55941266.76667.14
4560860-56086066.93967.31
5560257-56025766.86767.25
6327705-32770539.11239.28
45min1506491-50649160.45064.9115.9060.7365.3015.96
2558255-55825566.62867.03
3608043-60804372.57073.05
4601793-60179371.82572.31
5602202-60220271.87372.36
6386185-38618546.09246.33
60min1566507-56650767.61369.0713.6267.9969.5713.69
2589186-58918670.32070.84
3635288-63528875.82276.43
4627804-62780474.92975.54
5626021-62602174.71675.33
6427279-42727950.99651.31
极限1639947-63994776.37875.158.4076.8775.778.49
2635374-63537475.83276.47
3666193-66619379.51180.24
4657063-65706378.42179.15
5655077-65507778.18478.92
6524250-52425062.57062.97
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对照品来源自制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%
112.097722217727447722037718787724777723050.05
212.187707307711507709400.04
单位质量响应值RSD%判断
63879.6563295.570.65数据可信
供试品溶液-2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%
5min1772265-77226592.05789.926.0892.0689.926.08
2758213-75821390.38290.38
3664102-66410279.16479.16
4792150-79215094.42794.43
5761642-76164290.79190.79
6777431-77743192.67392.67
10min1813066-81306696.92194.794.0997.0794.944.09
2784492-78449293.51593.67
3734781-73478187.58987.72
4825483-82548398.40198.56
5805958-80595896.07396.22
6807604-80760496.27096.42
15min1824809-82480998.32196.082.9798.6496.392.98
2791497-79149794.35094.66
3765408-76540891.24091.52
4829793-82979398.91599.24
5813506-81350696.97397.28
6811276-81127696.70797.02
20min1829427-82942798.87196.642.2899.3597.112.29
2795240-79524094.79695.26
3783950-78395093.45093.88
4830288-83028898.97499.46
5813537-81353796.97797.45
6811731-81173196.76297.24
30min1828175-82817598.72297.101.5499.3797.721.55
2797206-79720695.03095.65
3806289-80628996.11396.70
4829401-82940198.86899.52
5812217-81221796.82097.45
6813902-81390297.02097.66
45min1831867-83186799.16297.591.6799.9798.381.66
2796853-79685394.98895.77
3828920-82892098.81199.56
4828897-82889798.80899.62
5812151-81215196.81297.61
6813289-81328996.94797.75
60min1830377-83037798.98497.641.9999.9698.601.97
2795494-79549494.82695.76
3839168-839168100.032100.94
4828454-82845498.75599.74
5810823-81082396.65397.61
6810486-81048696.61397.57
极限1827829-82782998.68197.732.3899.8298.852.35
2793590-79359094.59995.70
3850827-850827101.422102.50
4824936-82493698.33699.48
5811080-81108096.68497.80
6810954-81095496.66997.79
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对照品来源自制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%
112.097718867721927728417724997728147724460.06
212.187720857711497716170.09
单位质量响应值RSD%判断
63891.3263351.150.61数据可信
供试品溶液-2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%
5min1784196-78419693.43086.4114.0693.4386.4114.06
2572996-57299668.26768.27
3759035-75903590.43290.43
4811637-81163796.69996.70
5802445-80244595.60495.60
6621483-62148374.04474.04
10min1814701-81470197.06491.8411.6797.2291.9811.68
2632870-63287075.40175.51
3819065-81906597.58497.73
4832687-83268799.20799.37
5844154-844154100.573100.73
6681694-68169481.21781.34
15min1822058-82205897.94193.4110.0198.2693.7010.02
2663307-66330779.02779.27
3827650-82765098.60798.92
4837298-83729899.756100.08
5847243-847243100.941101.27
6706469-70646984.16984.43
20min1825840-82584098.39194.448.4098.8794.898.41
2689645-68964582.16582.54
3829740-82974098.85699.33
4836252-83625299.632100.12
5846703-846703100.877101.37
6727771-72777186.70787.11
30min1828214-82821498.67495.956.3499.3296.566.37
2725798-72579886.47286.98
3832081-83208199.13599.78
4838092-83809299.851100.51
5850716-850716101.355102.02
6757132-75713290.20590.75
45min1828384-82838498.69497.084.3699.5097.854.40
2759432-75943290.47991.13
3831484-83148499.06499.87
4837275-83727599.753100.58
5849804-849804101.246102.08
6782715-78271593.25393.95
60min1825661-82566198.37097.573.0699.3498.503.12
2778084-77808492.70193.50
3829330-82933098.80799.78
4832732-83273299.212100.20
5847126-847126100.927101.93
6800990-80099095.43096.28
极限1824680-82468098.25398.571.4199.3999.661.46
2809654-80965496.46397.42
3825171-82517198.31199.45
4831821-83182199.104100.26
5845549-845549100.739101.91
6827003-82700398.53099.54
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对照品来源自制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%
112.097724847723307727137727667722857725160.03
212.187732417729117730760.04
单位质量响应值RSD%判断
63897.1163470.940.48数据可信
供试品溶液-2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%
5min1778438-77843892.65286.326.5292.6586.326.52
2775016-77501692.24492.24
3659976-65997678.55278.55
4707349-70734984.19084.19
5692048-69204882.36982.37
6738581-73858187.90887.91
10min1810361-81036196.45192.962.9896.6193.102.98
2800894-80089495.32495.48
3747737-74773788.99789.13
4768725-76872591.49591.64
5769892-76989291.63491.77
6788498-78849893.84994.00
15min1812296-81229696.68195.241.7197.0095.541.72
2819182-81918297.50197.81
3784010-78401093.31593.59
4788728-78872893.87694.17
5795176-79517694.64494.93
6801961-80196195.45195.75
20min1816797-81679797.21796.241.9597.6996.701.96
2832639-83263999.10399.58
3791466-79146694.20294.64
4792298-79229894.30194.75
5805004-80500495.81396.26
6813169-81316996.78597.25
30min1814392-81439296.93196.280.8097.5796.900.81
2818698-81869897.44398.08
3807119-80711996.06596.66
4803520-80352095.63796.24
5802101-80210195.46896.08
6807620-80762096.12596.75
45min1815061-81506197.01096.891.5897.8197.671.59
2831474-83147498.96499.77
3811545-81154596.59297.34
4794060-79406094.51195.28
5808710-80871096.25597.02
6823415-82341598.00598.79
60min1817249-81724997.27196.461.1798.2397.401.18
2821043-82104397.72298.69
3807399-80739996.09997.01
4794378-79437894.54995.47
5808295-80829596.20597.13
6814152-81415296.90297.85
极限1820461-82046197.65396.911.4698.7898.011.46
2823850-82385098.05799.19
3821620-82162097.79198.86
4792216-79221694.29195.37
5809828-80982896.38897.47
6817433-81743397.29398.40
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对照品来源自制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%
112.097722967717117722867722797720637721270.04
212.187725557724467725000.01
单位质量响应值RSD%判断
63864.9363423.650.50数据可信
供试品溶液-2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%
5min1764022-76402290.99390.993.2190.9990.983.20
2781731-78173193.10293.10
3772115-77211591.95691.96
4777363-77736392.58192.58
5715517-71551785.21685.22
6773016-77301692.06492.06
10min1799680-79968095.23996.842.1095.3996.992.09
2839922-839922100.032100.19
3797369-79736994.96495.12
4821941-82194197.89198.04
5799892-79989295.26595.41
6819781-81978197.63397.79
15min1809127-80912796.36498.322.4496.6798.632.44
2861603-861603102.614102.94
3807858-80785896.21396.52
4833852-83385299.30999.63
5823111-82311198.03098.33
6817576-81757697.37197.69
20min1804299-80429995.78998.212.5196.2698.692.50
2860595-860595102.494102.99
3810542-81054296.53397.00
4830837-83083798.95099.43
5829650-82965098.80999.27
6812023-81202396.70997.19
30min1811916-81191696.69798.792.5297.3399.432.51
2866743-866743103.226103.89
3815234-81523497.09297.72
4833197-83319799.23199.88
5835187-83518799.468100.10
6814578-81457897.01497.65
45min1811961-81196196.70298.752.3997.4999.562.39
2859146-859146102.322103.16
3808255-80825596.26197.06
4835443-83544399.499100.31
5841963-841963100.275101.07
6818124-81812497.43698.24
60min1799928-79992895.26998.362.5896.2299.322.57
2856157-856157101.966102.97
3804857-80485795.85696.81
4826401-82640198.42299.40
5840971-840971100.157101.12
6826753-82675398.46499.43
极限1795412-79541294.73198.242.4895.8499.372.48
2848300-848300101.030102.21
3807759-80775996.20197.32
4827660-82766098.57299.71
5844188-844188100.540101.67
6825888-82588898.36199.49
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