盐酸伐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2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.073812183812353813243813203813233812840.02
212.153800833800273800550.02
单位质量响应值RSD%判断
31589.4031280.250.70数据可信
长期3月-供试品溶液-2023120221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%
2min1357717-35771786.25787.612.8486.2687.612.84
2377955-37795591.13791.14
3362886-36288687.50387.50
4369870-36987089.18789.19
5347753-34775383.85483.85
6363690-36369087.69787.70
5min1409293-40929398.69399.431.2098.6999.431.20
2406997-40699798.14098.14
3409339-40933998.70498.70
4419443-419443101.141101.14
5411853-41185399.31199.31
6417258-417258100.614100.61
10min1413287-41328799.656100.341.2099.66100.341.20
2410005-41000598.86598.87
3411948-41194899.33499.33
4422079-422079101.776101.78
5419642-419642101.189101.19
6419815-419815101.231101.23
15min1412311-41231199.421100.681.5099.42100.681.51
2411195-41119599.15299.15
3412701-41270199.51599.52
4424960-424960102.471102.47
5424234-424234102.296102.30
6419820-419820101.232101.23
20min1411176-41117699.147100.661.4499.15100.661.44
2412199-41219999.39499.39
3413029-41302999.59499.59
4423748-423748102.179102.18
5424013-424013102.243102.24
6420482-420482101.391101.39
30min1413178-41317899.630101.061.6099.63101.061.60
2413645-41364599.74399.74
3413740-41374099.76699.77
4425347-425347102.564102.56
5428507-428507103.326103.33
6420235-420235101.332101.33
45min1412946-41294699.574101.051.4899.57101.051.48
2414612-41461299.97699.98
3413540-41354099.71799.72
4425298-425298102.553102.55
5426736-426736102.899102.90
6421339-421339101.598101.60
极限1412866-41286699.555101.051.4999.55101.051.50
2414100-41410099.85299.85
3413667-41366799.74899.75
4425158-425158102.519102.52
5426609-426609102.869102.87
6422006-422006101.759101.76
盐酸伐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2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.073802603803963805543805213805013804460.04
212.153803063804443803750.03
单位质量响应值RSD%判断
31519.9731306.580.49数据可信
长期3月-供试品溶液-2023120521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%
2min1320779-32077977.40283.565.3177.4083.565.31
2338604-33860481.70381.70
3348497-34849784.09084.09
4377125-37712590.99891.00
5343166-34316682.80482.80
6349615-34961584.36084.36
5min1394307-39430795.14498.053.3695.1498.053.36
2411052-41105299.18499.18
3420500-420500101.464101.46
4422026-422026101.832101.83
5389403-38940393.96093.96
6400938-40093896.74496.74
10min1401153-40115396.79698.853.2496.8098.853.24
2407375-40737598.29798.30
3424819-424819102.506102.51
4426555-426555102.925102.93
5393594-39359494.97294.97
6404439-40443997.58997.59
15min1403138-40313897.27599.283.0097.2799.283.00
2408774-40877498.63598.63
3425815-425815102.746102.75
4427274-427274103.099103.10
5397180-39718095.83795.84
6406548-40654898.09798.10
20min1404952-40495297.71299.612.9597.7199.612.95
2409203-40920398.73898.74
3427983-427983103.270103.27
4428079-428079103.293103.29
5400008-40000896.51996.52
6406705-40670598.13598.14
30min1406542-40654298.096100.052.9198.10100.052.91
2410431-41043199.03499.03
3430695-430695103.924103.92
4428618-428618103.423103.42
5401778-40177896.94696.95
6409845-40984598.89398.89
45min1409181-40918198.733100.112.5698.73100.112.56
2410968-41096899.16499.16
3427984-427984103.270103.27
4428397-428397103.369103.37
5403696-40369697.40997.41
6409143-40914398.72498.72
极限1409810-40981098.885100.302.4898.88100.302.48
2411009-41100999.17499.17
3428286-428286103.343103.34
4429163-429163103.554103.55
5405700-40570097.89397.89
6410111-41011198.95798.96
盐酸伐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2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.073795723804873809633807233806783804850.15
212.153818253819013818630.02
单位质量响应值RSD%判断
31523.2031429.050.22数据可信
长期3月-供试品溶液-2023120621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%
2min1366061-36606188.15190.864.2488.1590.864.24
2392340-39234094.47994.48
3368786-36878688.80788.81
4375580-37558090.44390.44
5400963-40096396.55696.56
6360249-36024986.75186.75
5min1425098-425098102.368100.712.41102.37100.712.41
2419594-419594101.042101.04
3405226-40522697.58297.58
4409602-40960298.63698.64
5432724-432724104.204104.20
6416959-416959100.408100.41
10min1424717-424717102.276100.962.48102.28100.962.48
2420830-420830101.340101.34
3408058-40805898.26498.26
4409179-40917998.53498.53
5435788-435788104.942104.94
6416906-416906100.395100.39
15min1424815-424815102.300101.302.41102.30101.302.41
2421343-421343101.463101.46
3408993-40899398.48998.49
4409710-40971098.66298.66
5435831-435831104.952104.95
6423248-423248101.922101.92
20min1424589-424589102.245101.062.53102.25101.062.53
2420127-420127101.171101.17
3408656-40865698.40898.41
4410014-41001498.73598.74
5437419-437419105.335105.33
6417136-417136100.450100.45
30min1424789-424789102.293101.082.63102.29101.082.63
2420004-420004101.141101.14
3408766-40876698.43598.43
4410031-41003198.73998.74
5438548-438548105.607105.61
6416363-416363100.264100.26
45min1425611-425611102.491101.172.66102.49101.172.66
2419894-419894101.115101.11
3408220-40822098.30398.30
4410167-41016798.77298.77
5438738-438738105.652105.65
6418214-418214100.710100.71
极限1426442-426442102.691101.152.73102.69101.152.74
2420770-420770101.325101.33
3407611-40761198.15798.16
4409968-40996898.72498.72
5438717-438717105.647105.65
6416709-416709100.348100.35
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