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%
112.153854013843683859653866393867273858200.26
212.103860763869813865280.17
单位质量响应值RSD%判断
31754.7331944.460.43数据可信
加速6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%
5min1390309-39030992.49989.894.1092.5089.894.10
2355537-35553784.25884.26
3374921-37492188.85288.85
4399884-39988494.76894.77
5383432-38343290.86990.87
6371623-37162388.07088.07
10min1410960-41096097.39396.662.6397.5596.822.63
2402826-40282695.46595.61
3396358-39635893.93294.08
4427394-427394101.287101.45
5406753-40675396.39696.55
6402976-40297695.50195.65
15min1409506-40950697.04896.931.0497.3697.241.04
2410461-41046197.27497.57
3400970-40097095.02595.33
4413595-41359598.01798.34
5410208-41020897.21497.53
6409260-40926096.99097.30
20min1413400-41340097.97197.600.8498.4598.070.84
2412459-41245997.74898.21
3404883-40488395.95296.42
4412633-41263397.78998.28
5413650-41365098.03098.50
6413972-41397298.10698.57
30min1416608-41660898.73198.460.9099.3799.090.89
2417540-41754098.95299.58
3411370-41137097.49098.11
4412090-41209097.66098.31
5413951-41395198.10198.74
6421160-42116099.810100.44
45min1416741-41674198.76399.492.3499.57100.292.32
2418970-41897099.291100.08
3410002-41000297.16697.95
4412707-41270797.80798.62
5437459-437459103.673104.47
6423067-423067100.262101.06
60min1424056-424056100.49699.091.27101.47100.061.26
2421470-42147099.883100.84
3411337-41133797.48298.43
4412751-41275197.81798.80
5416904-41690498.80199.78
6422261-422261100.071101.04
极限1414341-41434198.19498.481.4099.3399.611.39
2422358-422358100.094101.22
3409504-40950497.04898.16
4408990-40899096.92698.07
5416195-41619598.63399.77
6421899-42189999.985101.12
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%
112.153878573870423873553886213856963873140.28
212.103886533869073877800.32
单位质量响应值RSD%判断
31877.7032047.930.38数据可信
加速6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%
5min1397530-39753093.87691.305.1393.8891.305.13
2418451-41845198.81698.82
3359402-35940284.87284.87
4382229-38222990.26390.26
5382776-38277690.39290.39
6379238-37923889.55689.56
10min1424747-424747100.30397.681.67100.4697.831.67
2418568-41856898.84499.01
3407945-40794596.33696.48
4407300-40730096.18396.33
5413529-41352997.65497.80
6409703-40970396.75196.90
15min1424639-424639100.27898.481.19100.6098.801.19
2418141-41814198.74399.07
3415503-41550398.12098.42
4409374-40937496.67396.98
5418011-41801198.71399.03
6416565-41656598.37198.68
20min1424860-424860100.33098.690.90100.8299.160.90
2418592-41859298.85099.34
3415134-41513498.03398.50
4414580-41458097.90298.37
5416446-41644698.34398.82
6417771-41777198.65699.13
30min1424950-424950100.35199.050.97101.0199.690.96
2416272-41627298.30298.96
3420098-42009899.20599.83
4417478-41747898.58799.22
5414635-41463597.91598.56
6423182-42318299.934100.57
45min1423693-423693100.05499.080.75100.8899.890.75
2416764-41676498.41899.24
3420639-42063999.333100.13
4416314-41631498.31299.11
5417482-41748298.58899.39
6422493-42249399.771100.58
60min1424946-424946100.35098.981.12101.3499.951.11
2414784-41478497.95198.94
3420715-42071599.351100.31
4418387-41838798.80199.76
5412942-41294297.51698.48
6423082-42308299.910100.88
极限1422707-42270799.82298.670.89100.9899.800.88
2413289-41328997.59798.75
3419074-41907498.964100.09
4416657-41665798.39399.52
5414338-41433897.84598.98
6420817-42081799.375100.51
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%
112.153887513879113858663879413868663874670.29
212.103863673852623858140.21
单位质量响应值RSD%判断
31890.2931885.450.02数据可信
加速6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%
5min1392943-39294393.01090.293.4893.0190.293.48
2386493-38649391.48491.48
3369038-36903887.35287.35
4393916-39391693.24193.24
5384791-38479191.08191.08
6361488-36148885.56585.56
10min1417058-41705898.71897.292.4298.8797.442.42
2415504-41550498.35098.50
3401426-40142695.01895.16
4421198-42119899.69899.85
5414979-41497998.22698.38
6396004-39600493.73593.88
15min1423011-423011100.12798.721.95100.4599.041.95
2421169-42116999.691100.01
3409446-40944696.91797.22
4425318-425318100.673101.00
5418622-41862299.08999.40
6404887-40488795.83796.14
20min1424463-424463100.47199.151.82100.9699.631.82
2420952-42095299.640100.12
3411577-41157797.42197.89
4424059-424059100.375100.86
5425103-425103100.623101.10
6407224-40722496.39196.85
30min1424881-424881100.57099.591.50101.22100.231.51
2423155-423155100.161100.81
3413960-41396097.98598.61
4424804-424804100.552101.21
5426042-426042100.845101.49
6411506-41150697.40498.02
45min1425727-425727100.77099.981.37101.59100.781.38
2425825-425825100.793101.61
3415615-41561598.37799.17
4426574-426574100.971101.79
5426203-426203100.883101.70
6414282-41428298.06198.84
60min1427125-427125101.10199.831.79102.09100.811.79
2426864-426864101.039102.02
3414447-41444798.10099.06
4425184-425184100.642101.63
5426939-426939101.057102.04
6410033-41003397.05598.00
极限1424361-424361100.447100.001.30101.60101.141.30
2424718-424718100.531101.68
3412378-41237897.61198.73
4424326-424326100.439101.60
5428223-428223101.361102.51
6420835-42083599.612100.72
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%
112.153868753867843862063884613876883872030.23
212.103896463857043876750.72
单位质量响应值RSD%判断
31868.5632039.260.38数据可信
加速6月-供试品溶液-BXJVV61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%
5min1393278-39327892.89888.814.1292.9088.814.11
2358571-35857184.70084.70
3386745-38674591.35591.35
4366453-36645386.56186.56
5389304-38930491.95991.96
6361576-36157685.40985.41
10min1416868-41686898.47094.792.3998.6294.932.39
2396898-39689893.75393.89
3407479-40747996.25296.40
4391842-39184292.55992.70
5401630-40163094.87195.02
6392951-39295192.82192.96
15min1416233-41623398.32096.191.2198.6496.501.21
2408878-40887896.58396.88
3406738-40673896.07796.39
4403507-40350795.31495.61
5402926-40292695.17795.49
6405124-40512495.69695.99
20min1416883-41688398.47496.751.1298.9697.221.12
2412441-41244197.42497.88
3405827-40582795.86296.33
4407362-40736296.22596.68
5404819-40481995.62496.09
6410187-41018796.89297.35
30min1416665-41666598.42297.780.7899.0798.400.77
2417177-41717798.54399.16
3409727-40972796.78397.42
4411968-41196897.31397.93
5411666-41166697.24197.87
6416423-41642398.36598.98
45min1414434-41443497.89597.281.2798.7198.071.27
2419370-41937099.06199.85
3407843-40784396.33897.13
4411251-41125197.14397.92
5404516-40451695.55296.34
6413569-41356997.69198.47
60min1416290-41629098.33497.461.6499.3198.421.63
2419334-41933499.053100.00
3406963-40696396.13097.08
4412986-41298697.55398.49
5402141-40214194.99195.94
6417940-41794098.72399.67
极限1411123-41112397.11397.032.0798.2598.142.05
2420953-42095399.435100.55
3405090-40509095.68896.80
4407812-40781296.33197.44
5399470-39947094.36095.47
6420181-42018199.253100.36
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