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%
112.307861107851227874657874677855637863450.14
212.257827527837937832720.10
单位质量响应值RSD%判断
63930.4963940.570.02数据可信
供试品溶液-2024062221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%
5min1367962-36796243.62342.628.7943.6242.628.79
2393361-39336146.63446.63
3395127-39512746.84346.84
4351394-35139441.65941.66
5322457-32245738.22838.23
6326833-32683338.74738.75
10min1455042-45504253.94753.464.5254.0253.534.52
2466795-46679555.34055.42
3474775-47477556.28656.36
4456176-45617654.08154.15
5426625-42662550.57850.64
6426097-42609750.51550.58
15min1523774-52377462.09561.893.3362.2662.053.33
2529799-52979962.80962.98
3544670-54467064.57264.74
4530745-53074562.92163.08
5505228-50522859.89660.04
6498185-49818559.06159.21
20min1574279-57427968.08268.032.1168.3568.302.12
2575666-57566668.24768.52
3586658-58665869.55069.83
4586800-58680069.56769.83
5561488-56148866.56666.81
6558228-55822866.18066.43
30min1642732-64273276.19875.721.3576.5876.101.35
2633225-63322575.07175.46
3642675-64267576.19176.59
4651970-65197077.29377.67
5632351-63235174.96775.33
6629245-62924574.59974.96
45min1696251-69625182.54381.750.9083.0582.250.90
2690416-69041681.85182.36
3687850-68785081.54782.07
4696296-69629682.54883.06
5686168-68616881.34781.83
6680448-68044880.66981.15
60min1724657-72465785.91085.261.0786.5585.891.07
2718083-71808385.13185.78
3713278-71327884.56185.22
4731873-73187386.76687.41
5713399-71339984.57585.19
6713506-71350684.58885.20
90min1749166-74916688.81688.250.5789.6089.030.57
2744629-74462988.27889.07
3740813-74081387.82588.62
4749695-74969588.87889.67
5739912-73991287.71988.48
6742305-74230588.00288.76
120min1761286-76128690.25389.400.9791.1990.330.98
2755081-75508189.51790.46
3755268-75526889.53990.48
4760720-76072090.18591.13
5750424-75042488.96589.87
6741710-74171087.93288.84
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1781903-78190392.69792.650.3893.7893.720.38
2777848-77784892.21693.30
3780216-78021692.49793.59
4785617-78561793.13794.23
5784059-78405992.95294.01
6779202-77920292.37793.43
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