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%
111.803749373743513752333762443742293749990.22
211.793758003756733757360.03
单位质量响应值RSD%判断
31779.5831869.040.20数据可信
长期12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%
5min1406205-40620596.34295.021.4196.3495.021.41
2404033-40403395.82695.83
3404743-40474395.99595.99
4398536-39853694.52394.52
5399236-39923694.68994.69
6391049-39104992.74792.75
10min1426719-426719101.20799.461.25101.3799.621.25
2419536-41953699.50399.66
3422113-422113100.115100.27
4419534-41953499.50399.66
5417232-41723298.95799.11
6411003-41100397.48097.63
15min1427160-427160101.312100.111.08101.64100.431.08
2419831-41983199.57399.90
3427905-427905101.488101.82
4421013-42101399.854100.18
5420324-42032499.690100.01
6416306-41630698.73799.05
20min1430491-430491102.102100.311.34102.60100.801.34
2420857-42085799.817100.31
3428838-428838101.710102.21
4421670-421670100.010100.50
5420145-42014599.648100.14
6415547-41554798.55799.04
30min1430883-430883102.195100.451.31102.86101.101.31
2422199-422199100.135100.79
3429446-429446101.854102.52
4422223-422223100.141100.80
5419349-41934999.459100.11
6416973-41697398.89699.54
45min1430904-430904102.200100.361.31103.04101.181.31
2421142-42114299.884100.71
3428726-428726101.683102.52
4421798-421798100.040100.86
5419590-41959099.516100.34
6416649-41664998.81999.63
60min1429631-429631101.898100.161.42102.91101.161.42
2420849-42084999.815100.81
3429135-429135101.780102.78
4421412-42141299.948100.94
5418162-41816299.178100.16
6414706-41470698.35899.33
极限1428974-428974101.74299.901.33102.92101.061.33
2420233-42023399.669100.83
3426833-426833101.234102.41
4419458-41945899.485100.64
5417440-41744099.006100.16
6414380-41438098.28199.42
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%
111.803752733756313755223735613732663746510.31
211.793764353757723761040.13
单位质量响应值RSD%判断
31750.0831900.250.34数据可信
长期12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%
5min1356933-35693384.65489.826.3984.6589.826.39
2402369-40236995.43095.43
3394038-39403893.45493.45
4359015-35901585.14785.15
5405138-40513896.08696.09
6354853-35485384.16084.16
10min1396352-39635294.00396.244.0294.1496.394.02
2423015-423015100.326100.49
3410142-41014297.27397.43
4395682-39568293.84493.99
5424943-424943100.783100.94
6384515-38451591.19591.34
15min1409634-40963497.15397.803.2097.4598.113.20
2426787-426787101.221101.55
3414862-41486298.39398.71
4403164-40316495.61895.92
5426350-426350101.117101.45
6393283-39328393.27593.57
20min1412402-41240297.80998.432.7198.2798.902.71
2426080-426080101.053101.55
3415521-41552198.54999.03
4406539-40653996.41996.88
5429388-429388101.838102.33
6400163-40016394.90695.35
30min1419166-41916699.41399.332.16100.0499.972.17
2429089-429089101.767102.43
3416395-41639598.75699.40
4408390-40839096.85897.48
5429545-429545101.875102.54
6410264-41026497.30297.91
45min1423123-423123100.35299.781.77101.14100.581.77
2428972-428972101.739102.57
3413138-41313897.98498.79
4413977-41397798.18398.96
5429262-429262101.808102.64
6415704-41570498.59299.36
60min1421213-42121399.89999.631.50100.85100.591.51
2428093-428093101.531102.53
3414960-41496098.41699.39
4412870-41287097.92098.86
5426578-426578101.171102.18
6416643-41664398.81599.75
极限1422189-422189100.13099.641.58101.25100.781.59
2426152-426152101.070102.24
3412288-41228897.78298.92
4414532-41453298.31499.42
5428771-428771101.691102.87
6416846-41684698.86399.96
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%
111.803766793760953768813767443768043766410.09
211.793755913756773756340.02
单位质量响应值RSD%判断
31918.7331860.390.13数据可信
长期12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%
5min1374456-37445688.63090.591.9288.6390.591.92
2394500-39450093.37493.37
3383144-38314490.68690.69
4376675-37667589.15589.15
5387206-38720691.64891.65
6380398-38039890.03690.04
10min1402983-40298395.38295.581.7595.5395.741.74
2415843-41584398.42698.58
3403136-40313695.41895.57
4393888-39388893.22993.38
5404697-40469795.78795.94
6402454-40245495.25795.41
15min1409160-40916096.84496.182.0697.1596.502.05
2419276-41927699.23899.56
3402250-40225095.20895.52
4393899-39389993.23293.54
5406935-40693596.31796.63
6406708-40670896.26396.57
20min1410750-41075097.22096.431.9097.6996.901.90
2420585-42058599.548100.03
3404368-40436895.71096.18
4397597-39759794.10794.57
5406837-40683796.29496.77
6404423-40442395.72396.19
30min1412584-41258497.65496.641.7598.2897.271.75
2419108-41910899.19899.85
3403818-40381895.57996.21
4398437-39843794.30694.92
5408465-40846596.67997.31
6407333-40733396.41197.04
45min1414166-41416698.02996.661.7998.8297.451.79
2418794-41879499.12499.94
3403546-40354695.51596.30
4398467-39846794.31395.09
5407176-40717696.37497.17
6408038-40803896.57897.37
60min1411495-41149597.39696.361.5998.3597.311.59
2416643-41664398.61599.60
3402812-40281295.34196.29
4398302-39830294.27495.20
5405910-40591096.07597.03
6407489-40748996.44897.40
极限1413210-41321097.80295.902.0598.9297.012.05
2415045-41504598.23799.38
3399095-39909594.46295.57
4393237-39323793.07594.16
5404073-40407395.64096.76
6406285-40628596.16397.27
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%
111.803752253757523735633734783750563746150.28
211.793758223756783757500.03
单位质量响应值RSD%判断
31747.0331870.230.28数据可信
长期12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%
5min1412254-41225497.82593.594.2497.8293.594.24
2367205-36720587.13587.13
3396352-39635294.05194.05
4411210-41121097.57797.58
5390948-39094892.76992.77
6388416-38841692.16892.17
10min1419538-41953899.55396.463.6499.7296.623.64
2382806-38280690.83790.98
3407981-40798196.81196.97
4423826-423826100.571100.73
5406008-40600896.34396.50
6398797-39879794.63194.79
15min1420507-42050799.78396.623.43100.1196.943.43
2384544-38454491.24991.55
3407419-40741996.67797.00
4423144-423144100.409100.74
5405013-40501396.10696.42
6402561-40256195.52595.84
20min1420167-42016799.70297.003.20100.2097.483.20
2387456-38745691.94092.39
3409794-40979497.24197.72
4424132-424132100.643101.14
5407848-40784896.77997.25
6403233-40323395.68496.15
30min1419351-41935199.50997.023.06100.1797.663.06
2388517-38851792.19292.79
3408116-40811696.84397.48
4424063-424063100.627101.29
5408917-40891797.03397.67
6404126-40412695.89696.53
45min1418763-41876399.36996.632.92100.2097.442.92
2388385-38838592.16192.92
3407645-40764596.73197.53
4420705-42070599.830100.66
5406482-40648296.45597.25
6401456-40145695.26296.05
60min1416758-41675898.89396.632.9099.8997.602.90
2388640-38864092.22193.13
3404885-40488596.07697.04
4422259-422259100.199101.20
5408504-40850496.93597.89
6402316-40231695.46696.42
极限1414896-41489698.45296.442.8999.6197.572.90
2386933-38693391.81692.88
3406479-40647996.45497.58
4420493-42049399.780100.95
5409087-40908797.07398.19
6400692-40069295.08196.19
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