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%
112.117615507617957614377610627599167611520.10
212.147616597603367609980.13
单位质量响应值RSD%判断
62853.1862685.170.19数据可信
供试品溶液-2024073021批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1721109-72110987.07889.591.8387.0889.591.83
2747101-74710190.21790.22
3748147-74814790.34390.34
4743453-74345389.77689.78
5759597-75959791.72691.73
6731930-73193088.38588.38
10min1783635-78363594.62994.021.7494.7794.171.74
2790773-79077395.49195.64
3781168-78116894.33194.48
4767603-76760392.69392.84
5791148-79114895.53695.69
6757216-75721691.43891.59
15min1757053-75705391.41994.232.1791.7294.542.17
2802512-80251296.90897.22
3775399-77539993.63493.94
4786205-78620594.93995.24
5793403-79340395.80896.12
6767671-76767192.70193.00
20min1794062-79406295.88895.861.7096.3496.321.70
2812146-81214698.07198.54
3794758-79475895.97296.44
4783283-78328394.58695.05
5803775-80377597.06197.53
6774750-77475093.55694.01
30min1783782-78378294.64695.871.5495.2696.501.54
2804272-80427297.12197.76
3798613-79861396.43797.06
4795043-79504396.00696.63
5806637-80663797.40698.04
6775209-77520993.61194.22
45min1789820-78982095.37595.291.6796.1596.071.67
2797659-79765996.32297.12
3801852-80185296.82897.61
4776369-77636993.75194.53
5799005-79900596.48597.28
6769897-76989792.97093.74
60min1779664-77966494.14996.041.7895.0896.981.78
2805247-80524797.23898.20
3800901-80090196.71497.66
4788749-78874995.24696.18
5815352-81535298.45999.42
6782130-78213094.44795.37
极限1791396-79139695.56695.772.3996.6596.872.38
2801167-80116796.74697.86
3792124-79212495.65496.76
4785329-78532994.83395.93
5823119-82311999.397100.52
6765502-76550292.43993.52
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%
112.117615117615057621567629577617427619740.09
212.147600187588027594100.12
单位质量响应值RSD%判断
62921.0662554.370.42数据可信
供试品溶液-2024073021批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1769950-76995093.02391.003.1193.0291.003.12
2787612-78761295.15795.16
3755451-75545191.27291.27
4742857-74285789.75089.75
5742808-74280889.74489.74
6720715-72071587.07587.07
10min1807568-80756897.56895.992.7997.7296.142.79
2821101-82110199.20399.36
3798349-79834996.45496.61
4767360-76736092.71092.86
5804663-80466397.21797.37
6767843-76784392.76992.91
15min1807754-80775497.59197.211.9597.9197.521.95
2822415-82241599.36299.69
3800763-80076396.74697.06
4795444-79544496.10396.41
5820145-82014599.08899.40
6780938-78093894.35194.65
20min1810821-81082197.96196.371.4698.4496.841.46
2810951-81095197.97798.47
3797010-79701096.29396.77
4795068-79506896.05896.52
5790456-79045695.50195.98
6781429-78142994.41094.87
30min1811026-81102697.98697.621.4998.6398.251.50
2822304-82230499.349100.00
3820585-82058599.14199.78
4794961-79496196.04596.67
5803752-80375297.10797.74
6795238-79523896.07996.69
45min1803785-80378597.11197.681.7397.9298.481.73
2835284-835284100.917101.74
3811388-81138898.03098.83
4802349-80234996.93897.72
5800676-80067696.73697.53
6797453-79745396.34697.12
60min1797571-79757196.36097.581.6197.3398.541.61
2824468-82446899.610100.60
3800174-80017496.67597.64
4798916-79891696.52397.47
5824330-82433099.593100.55
6800745-80074596.74497.68
极限1818395-81839598.87697.781.63100.0198.911.62
2825864-82586499.779100.93
3807370-80737097.54498.67
4793188-79318895.83196.94
5815997-81599798.58799.71
6795343-79534396.09197.19
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%
112.113822093824143823743821423827513823780.07
212.143817903818163818030.01
单位质量响应值RSD%判断
31575.3931450.000.29数据可信
供试品溶液-2024072621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1370619-37061989.14583.607.9389.1583.607.93
2298156-29815671.71671.72
3366585-36658588.17588.17
4334395-33439580.43280.43
5351582-35158284.56684.57
6363977-36397787.54887.55
10min1407299-40729997.96892.903.4198.1293.043.42
2366177-36617788.07788.20
3388130-38813093.35793.50
4384586-38458692.50592.64
5383065-38306592.13992.28
6388223-38822393.38093.53
15min1417568-417568100.43895.073.49100.7595.363.49
2374260-37426090.02190.29
3395327-39532795.08895.39
4394995-39499595.00895.30
5392471-39247194.40194.70
6396845-39684595.45395.75
20min1416411-416411100.16095.592.75100.6496.042.76
2383224-38322492.17792.59
3396707-39670795.42095.88
4397736-39773695.66896.11
5391777-39177794.23494.69
6398573-39857395.86996.33
30min1419908-419908101.00195.992.98101.6596.602.99
2385354-38535492.68993.26
3398323-39832395.80996.43
4403602-40360297.07997.68
5392110-39211094.31494.92
6395249-39524995.06995.69
45min1422568-422568101.64195.273.41102.4696.053.41
2384536-38453692.49393.22
3396011-39601195.25396.03
4392090-39209094.31095.08
5391664-39166494.20794.97
6389726-38972693.74194.52
60min1421811-421811101.45896.082.87102.4497.012.88
2389764-38976493.75094.63
3398796-39879695.92396.86
4395346-39534695.09396.02
5392876-39287694.49995.42
6398129-39812995.76296.70
极限1426038-426038102.47597.403.24103.6398.493.23
2397660-39766095.64996.68
3411468-41146898.971100.07
4405570-40557097.55298.64
5387540-38754093.21594.30
6401297-40129796.52497.62
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%
112.113813753815673817283817213815613815900.04
212.143820443816343818390.08
单位质量响应值RSD%判断
31510.3231452.970.13数据可信
供试品溶液-2024072621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1372361-37236189.65288.204.5689.6588.204.55
2395457-39545795.21395.21
3355099-35509985.49685.50
4347203-34720383.59583.60
5364850-36485087.84487.84
6363079-36307987.41787.42
10min1402060-40206096.80394.872.3196.9595.012.32
2408062-40806298.24898.41
3383966-38396692.44692.59
4391129-39112994.17194.31
5389233-38923393.71493.86
6389643-38964393.81393.96
15min1403851-40385197.23495.832.2297.5496.142.22
2406217-40621797.80498.13
3383844-38384492.41792.71
4405563-40556397.64697.94
5393458-39345894.73295.03
6395284-39528495.17195.47
20min1409648-40964898.63097.352.6999.1097.812.69
2421667-421667101.524102.01
3390472-39047294.01394.46
4405352-40535297.59598.05
5396329-39632995.42395.88
6402490-40249096.90697.37
30min1411188-41118899.00196.943.1299.6497.563.12
2421111-421111101.390102.04
3390220-39022093.95294.56
4407531-40753198.12098.74
5394228-39422894.91795.54
6391460-39146094.25194.87
45min1402859-40285996.99596.483.5797.8097.273.56
2425251-425251102.386103.21
3388273-38827393.48394.25
4405775-40577597.69798.48
5395813-39581395.29996.08
6386270-38627093.00193.78
60min1411826-41182699.15497.352.97100.1298.302.96
2418105-418105100.666101.66
3386375-38637593.02693.95
4411256-41125699.01799.96
5394188-39418894.90795.84
6404311-40431197.34598.28
极限1401782-40178296.73696.892.6797.8698.002.67
2415768-415768100.103101.27
3388191-38819193.46494.54
4413973-41397399.671100.78
5395016-39501695.10796.20
6399812-39981296.26297.36
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