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500
标示量(mg)20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%
112.233837773843123838223839523837733839270.06
212.283835253834393834820.02
单位质量响应值RSD%判断
31392.2331228.180.38数据可信
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%
5min1409106-40910699.03999.421.1899.0499.421.18
2417966-417966101.184101.18
3404307-40430797.87797.88
4412285-41228599.80999.81
5407237-40723798.58798.59
6413277-413277100.049100.05
10min1425045-425045102.898100.561.59103.06100.721.59
2418930-418930101.417101.59
3406522-40652298.41498.58
4415458-415458100.577100.74
5409843-40984399.21899.38
6416423-416423100.811100.98
15min1406038-40603898.296100.412.1398.63100.742.12
2419177-419177101.477101.81
3405884-40588498.25998.59
4429044-429044103.866104.20
5412259-41225999.802100.13
6416179-416179100.751101.09
20min1405207-40520798.09599.461.3598.6099.961.34
2418672-418672101.355101.86
3405142-40514298.08098.57
4413257-413257100.044100.55
5408290-40829098.84299.34
6414586-414586100.366100.87
30min1403531-40353197.69099.341.3698.35100.011.36
2417326-417326101.029101.70
3404876-40487698.01598.67
4413461-413461100.093100.77
5408554-40855498.90699.57
6414423-414423100.326101.00
45min1402654-40265497.47799.131.4198.3099.961.40
2417258-417258101.013101.86
3403896-40389697.77898.60
4412004-41200499.741100.58
5407505-40750598.65299.48
6413461-413461100.093100.93
60min1401256-40125697.13998.821.4598.1399.811.44
2416116-416116100.736101.75
3402935-40293597.54598.53
4409903-40990399.232100.24
5405659-40565998.20599.19
6413210-413210100.033101.04
极限1400693-40069397.00398.691.4798.1599.851.47
2415442-415442100.573101.75
3402233-40223397.37598.52
4409020-40902099.018100.19
5405251-40525198.10699.26
6413355-413355100.068101.24
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500
标示量(mg)20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%
112.237676667675977680877674527675347676670.04
212.287675237669747672480.06
单位质量响应值RSD%判断
62769.1762479.480.33数据可信
供试品溶液-BXJX091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%
5min1827957-827957100.212100.301.49100.21100.301.49
2847754-847754102.608102.61
3829157-829157100.358100.36
4823542-82354299.67899.68
5810116-81011698.05398.05
6833462-833462100.879100.88
10min1838141-838141101.445101.511.48101.61101.681.48
2855794-855794103.582103.75
3835137-835137101.081101.25
4842978-842978102.030102.20
5817928-81792898.99899.16
6842284-842284101.946102.11
15min1837108-837108101.320101.501.63101.66101.841.62
2856645-856645103.685104.03
3836285-836285101.220101.56
4843636-843636102.110102.45
5815221-81522198.67199.00
6842864-842864102.017102.35
20min1835483-835483101.123101.251.67101.63101.761.67
2856148-856148103.624104.14
3833766-833766100.915101.42
4840077-840077101.679102.19
5813182-81318298.42498.92
6840413-840413101.720102.23
30min1832204-832204100.726101.341.73101.40102.021.73
2852761-852761103.215103.90
3830445-830445100.513101.19
4853601-853601103.316103.99
5815697-81569798.72899.39
6838960-838960101.544102.22
45min1832106-832106100.715100.901.55101.56101.751.56
2850543-850543102.946103.81
3831158-831158100.600101.44
4839290-839290101.584102.43
5811430-81143098.21299.03
6837438-837438101.360102.21
60min1830698-830698100.544100.761.61101.55101.771.61
2850662-850662102.960103.99
3831065-831065100.589101.60
4836943-836943101.300102.32
5809529-80952997.98298.97
6836027-836027101.189102.20
极限1827857-827857100.200100.411.60101.38101.591.60
2847558-847558102.585103.79
3826073-82607399.984101.16
4835512-835512101.127102.31
5807432-80743297.72898.88
6833041-833041100.828102.01
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500
标示量(mg)20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%
112.233831573828103831223831693826163829750.07
212.283817963818793818380.02
单位质量响应值RSD%判断
31314.3931094.300.50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%
5min1413961-413961100.555101.381.18100.56101.381.17
2423923-423923102.975102.97
3420179-420179102.065102.07
4420071-420071102.039102.04
5415436-415436100.913100.91
6410597-41059799.73899.74
10min1419795-419795101.972102.361.15102.14102.521.15
2424600-424600103.139103.31
3423519-423519102.877103.05
4427216-427216103.775103.94
5419568-419568101.917102.09
6413528-413528100.450100.62
15min1418153-418153101.573102.341.39101.91102.681.39
2424414-424414103.094103.44
3423872-423872102.963103.30
4425151-425151103.273103.62
5425507-425507103.360103.70
6410758-41075899.777100.11
20min1418209-418209101.587102.121.64102.09102.631.64
2423387-423387102.845103.36
3424411-424411103.093103.61
4429917-429917104.431104.95
5416051-416051101.063101.57
6410501-41050199.715100.21
30min1416681-416681101.216101.661.26101.89102.341.26
2423351-423351102.836103.52
3421468-421468102.379103.06
4423452-423452102.861103.55
5416005-416005101.052101.73
6410032-41003299.601100.27
45min1415487-415487100.926101.441.36101.77102.291.36
2422333-422333102.589103.45
3421078-421078102.284103.14
4422902-422902102.727103.59
5415594-415594100.952101.80
6408141-40814199.14199.97
60min1413079-413079100.341101.121.24101.35102.141.24
2420722-420722102.197103.23
3419649-419649101.937102.96
4420956-420956102.254103.29
5415388-415388100.902101.92
6408051-40805199.119100.12
极限1413577-413577100.462101.792.60101.64102.982.58
2420259-420259102.085103.28
3439081-439081106.657107.85
4419559-419559101.915103.12
5414386-414386100.658101.84
6407423-40742398.967100.13
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500
标示量(mg)20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%
112.237665297675347685917681347673067676190.11
212.287655727665907660810.10
单位质量响应值RSD%判断
62765.2562384.450.44数据可信
供试品溶液-2024073021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%
5min1835579-835579101.215100.621.09101.22100.621.09
2822801-82280199.66799.67
3823322-82332299.73199.73
4825502-82550299.99599.99
5830375-830375100.585100.58
6846200-846200102.502102.50
10min1842872-842872102.099101.570.83102.27101.740.83
2831222-831222100.687100.85
3833108-833108100.916101.08
4834876-834876101.130101.30
5839288-839288101.665101.83
6849534-849534102.906103.08
15min1844306-844306102.272101.630.90102.61101.960.90
2835480-835480101.203101.54
3831528-831528100.725101.06
4832556-832556100.849101.18
5838960-838960101.625101.96
6851023-851023103.086103.43
20min1841219-841219101.898101.361.25102.41101.871.25
2827754-827754100.267100.77
3830780-830780100.634101.14
4830976-830976100.658101.16
5834197-834197101.048101.55
6855912-855912103.678104.19
30min1844946-844946102.350101.121.06103.03101.791.06
2825946-825946100.048100.72
3827956-827956100.292100.96
4830447-830447100.594101.26
5832814-832814100.880101.56
6846574-846574102.547103.23
45min1840627-840627101.827100.980.96102.68101.820.96
2826400-826400100.103100.94
3825709-825709100.020100.86
4829448-829448100.473101.31
5834181-834181101.046101.89
6845265-845265102.389103.25
60min1837196-837196101.411100.600.93102.43101.610.93
2821876-82187699.555100.56
3825188-82518899.957100.96
4826359-826359100.098101.10
5830280-830280100.573101.58
6841907-841907101.982103.01
极限1836280-836280101.300100.341.03102.49101.521.03
2820376-82037699.374100.54
3821074-82107499.458100.63
4823020-82302099.694100.87
5828512-828512100.359101.54
6840714-840714101.837103.04
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