替米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)0
对照品批号100629-202204对照品来源中检院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1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.767816237810047805037814397801427809420.08
211.547803717782307793000.20
单位质量响应值RSD%判断
66406.6367530.331.19数据可信
长期12月-供试品溶液-pH7.5
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024070321批174159574217474188499.71100.451.0299.38%～101.52%
2755033754345754689101.43
3746219746569746394100.32
4758541758119758330101.92
573893173907773900499.32
674358674437374398099.99
2024070421批1765774765979765876102.93101.860.96100.84%～102.89%
2750669750877750773100.90
3761505762631762068102.42
4747203747120747162100.42
5760691760822760756102.25
6760970760879760924102.27
2024070521批172093471998772046096.8399.582.6496.83%～102.33%
2753641753373753507101.27
3760027760125760076102.16
473459473567473513498.80
5759131759614759372102.06
671737571625371681496.34
替米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)0
对照品批号100629-202204对照品来源中检院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1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.767820207814917805537792917789327804570.18
211.547801227807077804140.06
单位质量响应值RSD%判断
66365.3967626.861.34数据可信
中间条件12月-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024070321批1749561751008750284100.80101.221.10100.06%～102.39%
2754786755518755152101.45
3764655763154763904102.63
4761559761388761474102.30
574229174357574293399.81
6746866747152747009100.36
2024070421批1758605758103758354101.88102.510.80101.65%～103.36%
2754529754203754366101.35
3771345771212771278103.62
4762467762739762603102.45
5767674766315766994103.04
6766155762744764450102.70
2024070521批1760726760303760514102.17101.801.53100.17%～103.44%
2771090771381771236103.61
374047674043474045599.48
4769368768551768960103.31
5754431754608754520101.37
6751229750693750961100.89
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