托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.484054464046724048944050584048324049800.08
216.554068944064854066900.08
单位质量响应值RSD%判断
24574.0324573.410.01数据可信
供试品溶液-3A75SDB1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%
5min132602-326027.9608.456.037.968.466.01
232706-327067.9867.99
335301-353018.6198.62
436667-366678.9538.95
537308-373089.1099.11
633158-331588.0968.10
10min168341-6834116.68617.154.7516.7017.164.75
269398-6939816.94416.96
369115-6911516.87516.89
476269-7626918.62218.64
571470-7147017.45017.47
666775-6677516.30416.32
15min1100936-10093624.64525.061.6924.6925.101.69
2102995-10299525.14825.19
3102306-10230624.97925.02
4105486-10548625.75625.80
5103239-10323925.20725.25
6100793-10079324.61024.65
20min1129051-12905131.51031.721.4631.5931.811.46
2129683-12968331.66431.75
3128671-12867131.41731.50
4133105-13310532.49932.59
5131119-13111932.01432.10
6127961-12796131.24331.33
30min1168681-16868141.18641.581.1541.3241.721.15
2169234-16923441.32141.46
3168305-16830541.09441.23
4173437-17343742.34742.49
5171328-17132841.83241.97
6170846-17084641.71441.85
45min1210811-21081151.47252.111.2151.6852.321.21
2211754-21175451.70351.91
3210929-21092951.50151.71
4215411-21541152.59552.81
5216778-21677852.92953.14
6214783-21478352.44252.65
60min1242648-24264859.24659.981.2159.5360.281.21
2244704-24470459.74860.04
3242021-24202159.09359.38
4247581-24758160.45060.75
5248943-24894360.78361.08
6248106-24810660.57860.87
90min1277322-27732267.71269.622.0168.1070.022.01
2280963-28096368.60168.99
3282404-28240468.95369.34
4288305-28830570.39370.80
5290166-29016670.84871.25
6291670-29167071.21571.61
120min1308437-30843775.30976.531.5875.8177.041.57
2310800-31080075.88676.39
3308707-30870775.37575.88
4314404-31440476.76677.29
5319382-31938277.98178.50
6318980-31898077.88378.39
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1321383-32138378.47079.431.5279.1080.071.51
2322553-32255378.75679.39
3319398-31939877.98578.62
4327550-32755079.97680.62
5328875-32887580.29980.95
6332060-33206081.07781.72
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