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%
112.113865693833203828753810483808073829240.61
212.143799113797463798280.04
单位质量响应值RSD%判断
31620.4831287.310.75数据可信
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%
5min1373513-37351390.01191.345.7590.0191.345.74
2381252-38125291.87691.88
3340464-34046482.04782.05
4401095-40109596.65896.66
5397927-39792795.89595.89
6379934-37993491.55991.56
10min1401229-40122996.69197.303.1496.8497.453.14
2403588-40358897.25997.41
3385884-38588492.99393.13
4416286-416286100.319100.48
5419700-419700101.142101.30
6395881-39588195.40295.55
15min1404260-40426097.42198.382.8197.7398.692.82
2408215-40821598.37498.69
3395546-39554695.32195.61
4420152-420152101.251101.58
5423387-423387102.030102.36
6397809-39780995.86696.18
20min1404987-40498797.59698.843.2698.0799.323.26
2409668-40966898.72499.20
3396014-39601495.43495.88
4428804-428804103.336103.83
5423263-423263102.000102.50
6398106-39810695.93896.41
30min1403526-40352697.24499.032.8497.8899.672.85
2410472-41047298.91899.56
3400351-40035196.47997.09
4425452-425452102.528103.20
5425055-425055102.432103.10
6400752-40075296.57697.21
45min1404891-40489197.57399.062.6398.3799.872.64
2410939-41093999.03199.84
3400833-40083396.59597.37
4424043-424043102.188103.03
5424387-424387102.271103.11
6401372-40137296.72597.52
60min1403119-40311997.14698.952.7798.1199.932.77
2412611-41261199.433100.41
3401473-40147396.74997.68
4423955-423955102.167103.18
5423931-423931102.161103.17
6398628-39862896.06497.02
极限1402243-40224396.93598.672.6798.0699.812.67
2411555-41155599.179100.32
3400615-40061596.54397.64
4421523-421523101.581102.76
5422863-422863101.904103.08
6397814-39781495.86896.98
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%
112.113903713902053870853864523842363876700.68
212.143804123805793804960.04
单位质量响应值RSD%判断
32012.3931342.341.50数据可信
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%
5min1397786-39778695.19391.955.5295.1991.945.52
2378319-37831990.53490.53
3376423-37642390.08090.08
4404977-40497796.91396.91
5348215-34821583.33083.33
6399608-39960895.62995.63
10min1406802-40680297.35097.611.7997.5197.771.80
2405721-40572197.09197.24
3411377-41137798.44598.60
4418412-418412100.129100.29
5396218-39621894.81794.96
6408865-40886597.84498.00
15min1405031-40503196.92699.041.7897.2599.361.78
2409683-40968398.04098.35
3419163-419163100.308100.62
4420920-420920100.729101.06
5407261-40726197.46097.76
6421213-421213100.799101.12
20min1403591-40359196.58298.931.5497.0699.411.54
2412365-41236598.68199.16
3418465-418465100.141100.62
4421510-421510100.870101.37
5414574-41457499.21099.67
6409964-40996498.10798.60
30min1405957-40595797.14899.501.7597.79100.141.74
2413502-41350298.95499.59
3418696-418696100.196100.84
4424230-424230101.521102.19
5422466-422466101.099101.72
6409749-40974998.05598.71
45min1403710-40371096.61099.472.2597.42100.282.23
2412294-41229498.66499.47
3419752-419752100.449101.26
4421560-421560100.882101.72
5428664-428664102.582103.38
6407891-40789197.61198.43
60min1401993-40199396.19999.302.2997.17100.282.27
2411618-41161898.50399.47
3418518-418518100.154101.14
4420626-420626100.658101.66
5428533-428533102.551103.51
6408515-40851597.76098.74
极限1402615-40261596.34899.152.2997.47100.292.27
2410876-41087698.32599.46
3417724-41772499.964101.11
4419310-419310100.343101.51
5428622-428622102.572103.71
6406775-40677597.34498.49
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