阿齐沙坦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%
110.312844642845912845862845152846842845680.03
210.242844462845642845050.03
单位质量响应值RSD%判断
27601.1627783.690.47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
2024030121129142829123329133094.4095.962.9792.97%～98.94%
228107228128728118091.11
330130330113330121897.60
429681329672829677096.16
530056430078830067697.43
630544530591430568099.05
2024030221128957328974928966193.8692.131.7790.42%～93.84%
227699427728427713989.80
328589028595828592492.65
428802128815028808693.35
528599128593328596292.66
627931527895827913690.45
2024030321129926829938929932896.9994.573.1291.48%～97.67%
227678727644727661789.63
329930529961929946297.03
429778329818529798496.55
528635828623328629692.77
629176329134829155694.47
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.816946969751695316952469344695240.22
214.837016769505698360.68
单位质量响应值RSD%判断
4694.404709.100.23数据可信
供试品溶液-氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121160786607386076283.7992.725.1487.72%～97.72%
266745666066667691.94
369193688406901695.17
469947697736986096.33
569953699696996196.47
667110672226716692.62
2024030221168042680406804193.8289.927.1883.15%～96.69%
269214690056911095.30
360836609636090083.98
457809580565793279.88
566599662836644191.62
668910687576883494.92
2024030321166631666766665491.9190.864.4786.60%～95.11%
262647629526280086.60
367854677226778893.48
466085663356621091.30
562202620076210485.64
669672698706977196.21
阿齐沙坦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%
110.312840962842532842642842022843712842370.04
210.242849082853542851310.12
单位质量响应值RSD%判断
27569.0627844.820.71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
20240301211313019312921312970101.36102.141.65100.38%～103.90%
2310781310254310518100.56
3324618324841324730105.17
4312089312451312270101.13
5314062313964314013101.70
6317810317749317780102.92
20240302211314958315798315378102.14102.291.70100.47%～104.11%
2312813313089312951101.35
3322320322083322202104.35
430715030797530756299.61
5315614316476316045102.35
6320657321144320900103.93
20240303211319167319153319160103.36102.011.18100.75%～103.27%
2310912311072310992100.72
3318925319317319121103.35
4314675314843314759101.94
5310679310727310703100.62
6316486313794315140102.06
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.817016169803700356993869920699710.20
214.837016270194701780.04
单位质量响应值RSD%判断
4724.584732.160.12数据可信
供试品溶液-氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121169941700206998095.9595.721.7893.94%～97.51%
269463697106958695.41
369958702037008096.09
471063711087108697.47
570723705147061896.83
667482675546751892.58
2024030221170186697446996595.9396.082.7393.33%～98.83%
270403704567043096.57
370351702227028696.37
466420665886650491.19
572302719997215098.93
671036711337108497.47
2024030321171021710187102097.3895.452.6292.83%～98.06%
266443667996662191.35
369906699046990595.85
468417688156861694.08
569827697126977095.67
671766716947173098.35
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