枸橼酸西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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.164856074856514856894855184852394855410.04
214.074847364844194845780.05
单位质量响应值RSD%判断
34289.6234440.510.32数据可信
供试品溶液-2024041221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1315012-31501258.01963.6010.8258.0263.6010.82
2312913-31291357.63257.63
3398516-39851673.39973.40
4329314-32931460.65360.65
5386306-38630671.15071.15
6329776-32977660.73860.74
5min1486833-48683389.66590.274.2589.6690.274.25
2464831-46483185.61385.61
3520023-52002395.77895.78
4473168-47316887.14887.15
5508103-50810393.58293.58
6487847-48784789.85289.85
10min1518563-51856395.50995.871.3695.5195.871.36
2511035-51103594.12294.12
3525109-52510996.71596.71
4515903-51590395.01995.02
5521378-52137896.02796.03
6531113-53111397.82097.82
15min1520796-52079695.92096.441.1895.9296.441.18
2516166-51616695.06795.07
3525550-52555096.79696.80
4520128-52012895.79795.80
5524808-52480896.65996.66
6534104-53410498.37198.37
20min1521585-52158596.06696.701.1196.0796.701.11
2518567-51856795.51095.51
3527763-52776397.20397.20
4522690-52269096.26996.27
5524558-52455896.61396.61
6535156-53515698.56598.57
30min1523502-52350296.41996.791.1696.4296.791.16
2518492-51849295.49695.50
3528293-52829397.30197.30
4522369-52236996.21096.21
5524498-52449896.60296.60
6536047-53604798.72998.73
45min1524021-52402196.51496.941.1696.5196.941.16
2519961-51996195.76695.77
3530704-53070497.74597.75
4521921-52192196.12796.13
5525070-52507096.70796.71
6536275-53627598.77198.77
极限1534462-53446298.43798.410.9098.4498.410.91
2528369-52836997.31597.31
3537224-53722498.94698.95
4530012-53001297.61897.62
5534179-53417998.38598.39
6541604-54160499.75399.75
枸橼酸西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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.164845254848084848304846794842694846220.05
214.074837284836234836760.02
单位质量响应值RSD%判断
34224.7234376.400.32数据可信
供试品溶液-2024041221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1326318-32631860.21463.729.5560.2163.729.55
2372214-37221468.68368.68
3302386-30238655.79855.80
4385579-38557971.14971.15
5321933-32193359.40559.41
6363602-36360267.09467.09
5min1520348-52034896.01894.262.6796.0294.262.67
2508660-50866093.86193.86
3509077-50907793.93893.94
4523229-52322996.55096.55
5485826-48582689.64889.65
6517723-51772395.53495.53
10min1532516-53251698.26397.961.1198.2697.961.11
2526482-52648297.15097.15
3535364-53536498.78998.79
4539518-53951899.55599.56
5526490-52649097.15197.15
6524856-52485696.85096.85
15min1532835-53283598.32297.671.0798.3297.661.07
2526974-52697497.24197.24
3534756-53475698.67798.68
4534487-53448798.62798.63
5525847-52584797.03397.03
6520764-52076496.09596.09
20min1533456-53345698.43798.061.0398.4498.061.03
2526943-52694397.23597.23
3532959-53295998.34598.34
4539915-53991599.62999.63
5530797-53079797.94697.95
6524442-52444296.77396.77
30min1536033-53603398.91298.350.9998.9198.350.99
2528072-52807297.44397.44
3536238-53623898.95098.95
4539394-53939499.53299.53
5532632-53263298.28598.28
6525647-52564796.99697.00
45min1535390-53539098.79498.461.0198.7998.461.01
2528581-52858197.53797.54
3537515-53751599.18699.19
4540406-54040699.71999.72
5533402-53340298.42798.43
6526331-52633197.12297.12
极限1539295-53929599.51498.931.5199.5198.931.52
2531812-53181298.13398.13
3542557-542557100.116100.12
4547056-547056100.946100.95
5526221-52622197.10297.10
6529863-52986397.77497.77
枸橼酸西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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.164844464846554833034835554833914838700.14
214.074809504847194828340.56
单位质量响应值RSD%判断
34171.6134316.560.30数据可信
供试品溶液-B736402批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1372106-37210668.77755.0042.3368.7855.0042.32
2351686-35168665.00265.00
3425472-42547278.64078.64
4117205-11720521.66321.66
5161961-16196129.93529.94
6356993-35699365.98365.98
5min1534276-53427698.75195.992.7598.7595.992.75
2518326-51832695.80295.80
3538771-53877199.58199.58
4511282-51128294.50194.50
5510425-51042594.34294.34
6502913-50291392.95492.95
10min1542950-542950100.35498.372.65100.3598.382.65
2526187-52618797.25597.26
3551295-551295101.896101.90
4535422-53542298.96298.96
5526034-52603497.22797.23
6511579-51157994.55594.56
15min1543115-543115100.38498.352.65100.3898.352.65
2526554-52655497.32397.32
3550554-550554101.759101.76
4535479-53547998.97398.97
5526112-52611297.24297.24
6510897-51089794.42994.43
20min1541789-541789100.13998.322.51100.1498.322.51
2526231-52623197.26497.26
3550205-550205101.695101.69
4534750-53475098.83898.84
5526431-52643197.30197.30
6512237-51223794.67794.68
30min1541805-541805100.14298.322.55100.1498.322.55
2526149-52614997.24897.25
3549826-549826101.625101.62
4534413-53441398.77698.78
5528669-52866997.71497.71
6510791-51079194.41094.41
45min1541464-541464100.07998.312.64100.0898.312.65
2526123-52612397.24497.24
3550270-550270101.707101.71
4534470-53447098.78698.79
5529782-52978297.92097.92
6509277-50927794.13094.13
极限1542111-542111100.19998.322.32100.2098.322.32
2525939-52593997.21097.21
3547210-547210101.141101.14
4534790-53479098.84698.85
5528921-52892197.76197.76
6512676-51267694.75894.76
枸橼酸西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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.164862174857824864904868144869624864530.10
214.074832204866364849280.50
单位质量响应值RSD%判断
34354.0334465.390.23数据可信
供试品溶液-B736402批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1372544-37254468.52667.2911.1368.5367.2911.13
2351278-35127864.61464.61
3356695-35669565.61165.61
4303011-30301155.73655.74
5385426-38542670.89570.90
6425898-42589878.34078.34
5min1534521-53452198.32095.532.7398.3295.522.73
2510623-51062393.92493.92
3538405-53840599.03599.03
4503325-50332592.58292.58
5518488-51848895.37195.37
6510633-51063393.92693.93
10min1511911-51191194.16197.772.6094.1697.772.60
2525316-52531696.62796.63
3525526-52552696.66696.67
4532584-53258497.96497.96
5550304-550304101.223101.22
6543437-54343799.96099.96
15min1542332-54233299.75798.122.6599.7698.122.65
2528069-52806997.13397.13
3550940-550940101.340101.34
4509471-50947193.71293.71
5535056-53505698.41998.42
6534615-53461598.33798.34
20min1541541-54154199.61197.772.5399.6197.772.53
2526080-52608096.76796.77
3549935-549935101.155101.16
4534176-53417698.25798.26
5525572-52557296.67496.67
6511861-51186194.15294.15
30min1540927-54092799.49897.712.3999.5097.712.39
2528861-52886197.27997.28
3511099-51109994.01294.01
4532758-53275897.99698.00
5525869-52586996.72996.73
6547623-547623100.730100.73
45min1524453-52445396.46897.602.5696.4797.602.56
2528630-52863097.23797.24
3508792-50879293.58893.59
4532926-53292698.02798.03
5541821-54182199.66399.66
6546970-546970100.610100.61
极限1542352-54235299.76197.652.3999.7697.652.39
2510647-51064793.92993.93
3528583-52858397.22897.23
4534268-53426898.27498.27
5545105-545105100.267100.27
6524369-52436996.45396.45
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