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%
111.973804083805243805003806543802743804720.04
211.993855103854293854700.02
单位质量响应值RSD%判断
31785.4632149.290.81数据可信
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%
5min1369287-36928787.56491.035.0687.5691.035.06
2375534-37553489.04589.05
3370145-37014587.76787.77
4372529-37252988.33388.33
5415789-41578998.59098.59
6400237-40023794.90394.90
10min1391542-39154292.84195.413.1792.9995.563.18
2396657-39665794.05494.20
3397540-39754094.26394.41
4393085-39308593.20793.35
5424049-424049100.549100.71
6411499-41149997.57397.73
15min1397772-39777294.31896.852.5394.6297.162.54
2402418-40241895.42095.72
3405292-40529296.10196.40
4403419-40341995.65795.96
5425276-425276100.840101.17
6416467-41646798.75199.07
20min1402174-40217495.36297.512.1695.8297.982.17
2404120-40412095.82396.29
3407834-40783496.70497.17
4409707-40970797.14897.61
5425356-425356100.859101.36
6418193-41819399.16099.65
30min1405664-40566496.18998.041.9296.8198.671.93
2405612-40561296.17796.80
3409630-40963097.13097.75
4414857-41485798.36998.99
5424805-424805100.728101.40
6420172-42017299.630100.28
45min1407978-40797896.73898.221.7997.5299.011.80
2405406-40540696.12896.91
3410034-41003497.22698.01
4417950-41795099.10399.89
5423890-423890100.511101.35
6419978-41997899.584100.40
60min1414574-41457498.30298.732.0499.2499.692.04
2405078-40507896.05196.99
3409253-40925397.04197.99
4418466-41846699.225100.18
5423264-423264100.363101.37
6427598-427598101.390102.37
极限1407818-40781896.70097.951.7997.8099.071.79
2403985-40398595.79196.90
3408182-40818296.78797.90
4417280-41728098.944100.06
5422354-422354100.147101.32
6418816-41881699.308100.46
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%
111.973809953813793812683808563807173810430.08
211.993813923818373816140.09
单位质量响应值RSD%判断
31833.1731827.690.02数据可信
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%
5min1373849-37384989.02491.616.8089.0291.616.80
2337097-33709780.27280.27
3397880-39788094.74794.75
4398335-39833594.85594.85
5409761-40976197.57697.58
6391254-39125493.16993.17
10min1386792-38679292.10695.124.3392.2595.284.34
2372130-37213088.61588.75
3407130-40713096.94997.11
4408922-40892297.37697.53
5420291-420291100.083100.25
6401497-40149795.60895.76
15min1398546-39854694.90596.543.0695.2196.853.07
2385470-38547091.79192.07
3410217-41021797.68498.00
4410133-41013397.66497.98
5422075-422075100.508100.84
6405994-40599496.67996.99
20min1395417-39541794.16097.213.0994.6297.683.10
2392329-39232993.42593.86
3420732-420732100.188100.67
4410160-41016097.67198.15
5422996-422996100.727101.22
6407677-40767797.08097.56
30min1390947-39094793.09697.392.5493.7198.022.54
2407990-40799097.15497.74
3413369-41336998.43599.08
4409772-40977297.57898.22
5422762-422762100.672101.34
6409093-40909397.41798.05
45min1398767-39876794.95897.951.9295.7398.751.93
2409606-40960697.53998.29
3412649-41264998.26499.08
4415581-41558198.96299.77
5422532-422532100.617101.45
6408925-40892597.37798.18
60min1410790-41079097.82198.081.1698.7599.041.16
2411730-41173098.04598.96
3411644-41164498.02499.00
4408355-40835597.24198.21
5420993-420993100.250101.25
6407882-40788297.12898.09
极限1413266-41326698.41098.241.2299.5099.361.21
2414296-41429698.65699.73
3413150-41315098.38399.52
4407168-40716896.95898.09
5420407-420407100.111101.28
6407054-40705496.93198.06
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%
111.973803403803283804763805873805473804560.04
211.993814863814433814640.01
单位质量响应值RSD%判断
31784.1331815.180.07数据可信
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%
5min1296249-29624970.61490.0911.5770.6190.0911.57
2378113-37811390.12790.13
3369508-36950888.07688.08
4401267-40126795.64695.65
5415509-41550999.04099.04
6407079-40707997.03197.03
10min1370261-37026188.25595.574.0988.3795.724.10
2398253-39825394.92795.08
3403369-40336996.14796.29
4406361-40636196.86097.02
5417455-41745599.50499.67
6410088-41008897.74897.91
15min1383055-38305591.30596.593.0791.5796.903.08
2401090-40109095.60395.91
3411791-41179198.15498.46
4405173-40517396.57796.90
5418373-41837399.723100.05
6411888-41188898.17798.50
20min1393342-39334293.75797.072.2094.1797.542.22
2403454-40345496.16796.63
3415652-41565299.07499.55
4403555-40355596.19196.67
5417218-41721899.44899.94
6410230-41023097.78298.27
30min1403644-40364496.21297.881.6196.7998.511.61
2408360-40836097.33697.96
3420958-420958100.339100.97
4405195-40519596.58297.22
5415754-41575499.09999.76
6409872-40987297.69798.35
45min1411840-41184098.16698.181.8598.9098.971.84
2406425-40642596.87597.67
3424515-424515101.187101.99
4403816-40381696.25397.06
5416524-41652499.282100.11
6408171-40817197.29198.11
60min1414635-41463598.83298.321.7299.7399.281.70
2406980-40698097.00797.96
3424332-424332101.143102.12
4404283-40428396.36597.33
5414137-41413798.71399.71
6410505-41050597.84898.82
极限1415089-41508998.94098.351.81100.0099.471.79
2406078-40607896.79297.91
3425510-425510101.424102.56
4406230-40623096.82997.95
5414476-41447698.79499.95
6408316-40831697.32698.47
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%
111.973808703809953808153807543808323808530.03
211.993809763807283808520.05
单位质量响应值RSD%判断
31817.2931764.140.12数据可信
供试品溶液-2024072521批-pH1.05
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1396067-39606794.43390.406.0394.4390.406.03
2371293-37129388.52688.53
3396692-39669294.58294.58
4400855-40085595.57495.57
5342473-34247381.65581.65
6367555-36755587.63587.63
10min1408068-40806897.29496.533.5697.4596.683.56
2418267-41826799.72699.87
3417127-41712799.45499.61
4409869-40986997.72497.88
5380939-38093990.82690.96
6395023-39502394.18494.33
15min1407912-40791297.25797.333.6597.5897.643.65
2420291-420291100.208100.52
3427489-427489101.925102.25
4410276-41027697.82198.14
5396153-39615394.45394.74
6387290-38729092.34092.64
20min1408463-40846397.38897.952.1397.8798.422.14
2421159-421159100.415100.90
3421428-421428100.480100.97
4409433-40943397.62098.10
5400417-40041795.47095.91
6404035-40403596.33396.79
30min1407441-40744197.14598.251.8697.7998.891.87
2421004-421004100.378101.03
3422630-422630100.766101.43
4409205-40920597.56598.21
5406757-40675796.98297.59
6405478-40547896.67797.29
45min1406823-40682396.99798.581.6597.8099.381.65
2421090-421090100.399101.21
3422443-422443100.722101.55
4407956-40795697.26798.08
5413297-41329798.54199.31
6409242-40924297.57498.35
60min1406888-40688897.01398.701.5197.9899.661.50
2420666-420666100.298101.28
3421020-421020100.382101.38
4407297-40729797.11098.08
5415450-41545099.05499.98
6412407-41240798.32999.27
极限1405667-40566796.72298.311.8297.8599.441.82
2419755-419755100.081101.23
3420253-420253100.199101.36
4406565-40656596.93698.07
5417251-41725199.484100.58
6404484-40448496.44097.54
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