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%
112.303969303977753970153973693974513973080.09
212.253914523898583906550.29
单位质量响应值RSD%判断
32301.4631890.200.91数据可信
供试品溶液-24062601(YD1)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%
5min1385405-38540591.02191.565.2491.0291.565.24
2397099-39709993.78393.78
3378980-37898089.50389.50
4396933-39693393.74393.74
5354068-35406883.62083.62
6413645-41364597.69097.69
10min1397996-39799693.99495.314.4994.1595.464.49
2414248-41424897.83397.99
3399710-39971094.39994.55
4407402-40740296.21696.37
5374061-37406188.34288.48
6427896-427896101.056101.22
15min1402685-40268595.10295.803.7595.4196.113.75
2415445-41544598.11598.43
3395920-39592093.50493.81
4408979-40897996.58896.90
5383684-38368490.61490.90
6427159-427159100.882101.21
20min1403544-40354495.30596.463.2195.7796.933.21
2416817-41681798.43998.92
3400055-40005594.48194.94
4410712-41071296.99897.48
5391292-39129292.41192.85
6428226-428226101.134101.63
30min1406261-40626195.94697.312.3596.5797.942.36
2417115-41711598.51099.16
3406833-40683396.08196.70
4412516-41251697.42498.06
5401230-40123094.75895.35
6428237-428237101.136101.80
45min1407371-40737196.20897.372.2296.9998.162.23
2418166-41816698.75899.57
3403347-40334795.25896.04
4410088-41008896.85097.65
5406840-40684096.08396.83
6427925-427925101.063101.90
60min1408305-40830596.42997.301.9397.3898.261.94
2416227-41622798.30099.28
3403823-40382395.37196.31
4409273-40927396.65897.62
5408317-40831796.43297.34
6425924-425924100.590101.60
极限1405578-40557895.78597.092.0296.8998.212.03
2414950-41495097.99899.14
3401873-40187394.91096.01
4409633-40963396.74397.87
5409200-40920096.64097.71
6425489-425489100.487101.66
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