阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.034806047931479334796847988479760.11
212.024760547617476110.02
单位质量响应值RSD%判断
3988.033960.980.49数据可信
供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
24051501批1493624928949326100.30100.883.2897.41%～104.35%
248572486174859498.81
349186490944914099.92
4493314923249282100.21
548448485124848098.58
6528855282352854107.47
24051502批147015466954685595.27100.482.9097.43%～103.53%
2494624916949316100.28
3499125012650019101.71
449122490414908299.80
5501985024650222102.12
6509755102751001103.71
24051503批1502875027050278102.24102.242.8999.15%～105.34%
2495124947249492100.64
3518725166651769105.27
4512905141551352104.42
547737479014781997.24
6509485099150970103.64
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.173897233899093900513899893898693899080.04
211.153878773883313881040.09
单位质量响应值RSD%判断
34906.7134807.530.21数据可信
供试品溶液-阿齐沙坦-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
24051501批1394726394838394782101.63100.441.4798.90%～101.98%
2395674395693395684101.86
338286838345438316198.63
438228038385338306698.61
5391644390479391062100.67
6393748392955393352101.26
24051502批1396090396851396470102.06101.341.3599.91%～102.78%
2392942393948393445101.28
338545038699538622299.42
4397857396688397272102.27
5398969400974399972102.96
6388544388863388704100.06
24051503批1387584389512388548100.02100.731.4499.22%～102.24%
2394677395919395298101.76
338839738793138816499.92
4387791389402388596100.03
5400318401414400866103.19
638663238609438636399.46
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