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对照品来源自制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%
112.117621707578617579067573447576637585890.27
212.147514197522107518140.08
单位质量响应值RSD%判断
62641.5461928.670.81数据可信
供试品溶液-BXJX091批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1653876-65387679.57681.573.4179.5881.573.40
2670599-67059981.61181.61
3658904-65890480.18780.19
4682993-68299383.11983.12
5646479-64647978.67578.68
6708622-70862286.23886.24
10min1711884-71188486.63589.392.5086.7789.532.49
2732963-73296389.20089.34
3753467-75346791.69691.83
4737476-73747689.75089.89
5715822-71582287.11487.25
6755509-75550991.94492.09
15min1726033-72603388.35792.402.6788.6392.692.67
2763856-76385692.96093.24
3777837-77783794.66194.95
4765576-76557693.16993.46
5744894-74489490.65290.93
6777573-77757394.62994.93
20min1733786-73378689.30093.632.6989.7294.072.69
2768780-76878093.55994.00
3793399-79339996.55597.00
4776632-77663294.51594.96
5761400-76140092.66193.09
6782289-78228995.20395.66
30min1745256-74525690.69694.712.5791.2795.302.56
2775829-77582994.41795.01
3804951-80495197.96198.57
4788992-78899296.01996.62
5771643-77164393.90894.49
6782676-78267695.25095.86
45min1754769-75476991.85495.772.4892.5896.522.47
2786171-78617195.67696.43
3814610-81461099.13799.91
4786214-78621495.68196.44
5783830-78383095.39196.13
6795905-79590596.86097.63
60min1757532-75753292.19095.992.5893.0796.902.58
2781245-78124595.07695.99
3816522-81652299.369100.30
4795024-79502496.75397.67
5780751-78075195.01695.91
6801443-80144397.53498.47
90min1766469-76646993.27896.732.0094.3197.802.00
2792966-79296696.50397.57
3811788-81178898.79399.89
4803681-80368197.80798.89
5803103-80310397.73698.79
6791210-79121096.28997.38
120min1-0.0000.00-1.191.232.16
2-0.0001.23
3-0.0001.26
4-0.0001.24
5-0.0001.22
6-0.0001.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.191.232.16
2-0.0001.23
3-0.0001.26
4-0.0001.24
5-0.0001.22
6-0.0001.26
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对照品来源自制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%
112.117639087644397641767649477636247642190.07
212.147676447682217679320.06
单位质量响应值RSD%判断
63106.4463256.340.17数据可信
供试品溶液-BXJX091批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1164119-16411919.68922.457.3619.6922.457.36
2183172-18317221.97521.97
3182084-18208421.84421.84
4194333-19433323.31423.31
5202503-20250324.29424.29
6196587-19658723.58423.58
10min1263438-26343831.60433.134.4031.6433.174.40
2266931-26693132.02332.06
3265126-26512631.80731.84
4285264-28526434.22334.26
5287203-28720334.45534.50
6288912-28891234.66034.70
15min1290874-29087434.89638.556.5734.9838.646.57
2312422-31242237.48137.57
3307125-30712536.84536.93
4333124-33312439.96440.06
5341102-34110240.92141.02
6343348-34334841.19141.29
20min1321645-32164538.58742.506.5138.7342.666.51
2345762-34576241.48041.63
3336156-33615640.32840.48
4369541-36954144.33344.50
5375356-37535645.03145.20
6376944-37694445.22145.39
30min1366926-36692644.01948.336.4144.2348.566.41
2391360-39136046.95147.17
3383261-38326145.97946.20
4421609-42160950.58050.82
5429166-42916651.48651.73
6424751-42475150.95751.20
45min1413720-41372049.63354.406.7949.9154.706.78
2440329-44032952.82553.13
3428631-42863151.42251.72
4467800-46780056.12156.44
5494084-49408459.27459.60
6475973-47597357.10257.43
60min1441352-44135252.94858.716.7153.3159.116.71
2477263-47726357.25657.64
3466073-46607355.91456.29
4510580-51058061.25361.67
5521522-52152262.56662.99
6519493-51949362.32362.74
90min1498873-49887359.84965.346.0360.3065.836.03
2528549-52854963.40963.89
3521288-52128862.53863.01
4566445-56644567.95568.47
5579000-57900069.46169.99
6573478-57347868.79969.32
120min1541833-54183365.00369.955.3465.5570.555.35
2569856-56985668.36568.95
3557693-55769366.90567.48
4604335-60433572.50173.13
5621314-62131474.53875.18
6603234-60323472.36973.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1649002-64900277.85980.672.6178.5281.402.64
2657472-65747278.87679.58
3667538-66753880.08380.77
4679209-67920981.48382.23
5687851-68785182.52083.29
6693641-69364183.21583.98
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