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%
112.233837773843123838223839523837733839270.06
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%
5min1409106-40910698.62399.011.1898.6299.011.18
2417966-417966100.759100.76
3404307-40430797.46697.47
4412285-41228599.39099.39
5407237-40723798.17398.17
6413277-41327799.62999.63
10min1425045-425045102.466100.131.59102.63100.301.59
2418930-418930100.992101.16
3406522-40652298.00098.16
4415458-415458100.155100.32
5409843-40984398.80198.96
6416423-416423100.387100.55
15min1406038-40603897.88499.992.1398.22100.322.12
2419177-419177101.051101.39
3405884-40588497.84798.17
4429044-429044103.430103.76
5412259-41225999.38399.71
6416179-416179100.328100.66
20min1405207-40520797.68399.051.3598.1899.541.34
2418672-418672100.929101.43
3405142-40514297.66898.16
4413257-41325799.624100.13
5408290-40829098.42798.92
6414586-41458699.944100.44
30min1403531-40353197.27998.931.3697.9499.591.36
2417326-417326100.605101.28
3404876-40487697.60498.26
4413461-41346199.673100.34
5408554-40855498.49099.15
6414423-41442399.905100.57
45min1402654-40265497.06898.711.4197.8999.541.40
2417258-417258100.589101.43
3403896-40389697.36798.18
4412004-41200499.322100.16
5407505-40750598.23799.06
6413461-41346199.673100.51
60min1401256-40125696.73198.401.4597.7299.391.44
2416116-416116100.313101.32
3402935-40293597.13698.11
4409903-40990398.81599.82
5405659-40565997.79298.78
6413210-41321099.613100.61
极限1400693-40069396.59598.281.4797.7499.431.47
2415442-415442100.151101.33
3402233-40223396.96698.10
4409020-40902098.60399.77
5405251-40525197.69498.84
6413355-41335599.648100.81
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%
112.237676667675977680877674527675347676670.04
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%
5min1827957-82795799.79299.881.4999.7999.881.49
2847754-847754102.178102.18
3829157-82915799.93699.94
4823542-82354299.25999.26
5810116-81011697.64197.64
6833462-833462100.455100.46
10min1838141-838141101.019101.091.48101.19101.261.48
2855794-855794103.147103.32
3835137-835137100.657100.82
4842978-842978101.602101.77
5817928-81792898.58398.75
6842284-842284101.518101.69
15min1837108-837108100.894101.081.63101.23101.411.63
2856645-856645103.249103.59
3836285-836285100.795101.13
4843636-843636101.681102.02
5815221-81522198.25798.58
6842864-842864101.588101.92
20min1835483-835483100.699100.821.67101.20101.321.67
2856148-856148103.189103.70
3833766-833766100.492100.99
4840077-840077101.252101.76
5813182-81318298.01198.50
6840413-840413101.293101.80
30min1832204-832204100.303100.911.73100.97101.591.73
2852761-852761102.781103.47
3830445-830445100.091100.76
4853601-853601102.882103.56
5815697-81569798.31498.97
6838960-838960101.118101.79
45min1832106-832106100.292100.481.55101.13101.321.55
2850543-850543102.514103.37
3831158-831158100.177101.01
4839290-839290101.157102.00
5811430-81143097.80098.62
6837438-837438100.934101.78
60min1830698-830698100.122100.341.61101.13101.351.61
2850662-850662102.528103.56
3831065-831065100.166101.17
4836943-836943100.875101.89
5809529-80952997.57098.55
6836027-836027100.764101.78
极限1827857-82785799.77999.991.60100.95101.161.60
2847558-847558102.154103.35
3826073-82607399.564100.74
4835512-835512100.702101.88
5807432-80743297.31898.46
6833041-833041100.404101.58
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%
112.233831573828103831223831693826163829750.07
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%
5min1413961-413961100.133100.961.18100.13100.961.18
2423923-423923102.543102.54
3420179-420179101.637101.64
4420071-420071101.611101.61
5415436-415436100.490100.49
6410597-41059799.31999.32
10min1419795-419795101.544101.931.15101.71102.091.15
2424600-424600102.706102.88
3423519-423519102.445102.61
4427216-427216103.339103.51
5419568-419568101.489101.66
6413528-413528100.028100.19
15min1418153-418153101.147101.911.39101.48102.251.39
2424414-424414102.661103.00
3423872-423872102.530102.87
4425151-425151102.840103.18
5425507-425507102.926103.26
6410758-41075899.35899.69
20min1418209-418209101.160101.691.64101.67102.201.64
2423387-423387102.413102.93
3424411-424411102.661103.17
4429917-429917103.992104.51
5416051-416051100.638101.15
6410501-41050199.29699.79
30min1416681-416681100.791101.231.26101.46101.911.26
2423351-423351102.404103.09
3421468-421468101.949102.63
4423452-423452102.429103.11
5416005-416005100.627101.30
6410032-41003299.18299.85
45min1415487-415487100.502101.011.36101.34101.861.36
2422333-422333102.158103.01
3421078-421078101.854102.71
4422902-422902102.296103.15
5415594-415594100.528101.37
6408141-40814198.72599.55
60min1413079-41307999.919100.701.24100.93101.721.24
2420722-420722101.768102.79
3419649-419649101.509102.53
4420956-420956101.825102.85
5415388-415388100.478101.49
6408051-40805198.70399.70
极限1413577-413577100.040101.362.60101.22102.542.58
2420259-420259101.656102.85
3439081-439081106.209107.40
4419559-419559101.487102.68
5414386-414386100.236101.41
6407423-40742398.55199.71
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%
112.237665297675347685917681347673067676190.11
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%
5min1835579-835579100.790100.191.09100.79100.191.09
2822801-82280199.24999.25
3823322-82332299.31299.31
4825502-82550299.57599.57
5830375-830375100.163100.16
6846200-846200102.071102.07
10min1842872-842872101.670101.140.83101.84101.310.82
2831222-831222100.265100.43
3833108-833108100.492100.66
4834876-834876100.705100.87
5839288-839288101.238101.40
6849534-849534102.474102.64
15min1844306-844306101.843101.200.90102.18101.530.90
2835480-835480100.778101.11
3831528-831528100.302100.63
4832556-832556100.426100.76
5838960-838960101.198101.53
6851023-851023102.653102.99
20min1841219-841219101.471100.941.25101.98101.441.25
2827754-82775499.846100.35
3830780-830780100.211100.71
4830976-830976100.235100.74
5834197-834197100.624101.13
6855912-855912103.243103.75
30min1844946-844946101.920100.691.06102.60101.371.06
2825946-82594699.628100.30
3827956-82795699.871100.54
4830447-830447100.171100.84
5832814-832814100.457101.13
6846574-846574102.116102.80
45min1840627-840627101.399100.550.96102.25101.390.96
2826400-82640099.683100.52
3825709-82570999.600100.43
4829448-829448100.051100.89
5834181-834181100.622101.46
6845265-845265101.959102.81
60min1837196-837196100.985100.170.93102.00101.180.93
2821876-82187699.137100.14
3825188-82518899.537100.54
4826359-82635999.678100.68
5830280-830280100.151101.16
6841907-841907101.554102.58
极限1836280-836280100.87599.921.03102.06101.091.03
2820376-82037698.956100.12
3821074-82107499.041100.21
4823020-82302099.275100.44
5828512-82851299.938101.11
6840714-840714101.410102.60
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