厄贝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左氨氯地平需分装，厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
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%
113.863165831608316673148131480315790.30
213.973188132072319760.43
单位质量响应值RSD%判断
2278.432288.900.33数据可信
影响因素30天-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
2024042411批裸放高温132085318103194888.3391.443.1888.39%～94.49%
232063317783192088.25
332838328653285290.83
433974340963403594.10
533296331293321291.82
634506344223446495.29
2024042411批裸放高湿132949326143278290.6388.762.3986.54%～90.99%
231226314403133386.63
331371312983133486.63
432154320743211488.79
533091333383321491.83
631978317333185688.07
2024042411批裸放光照129867298572986282.5681.103.8077.87%～84.33%
228229284542834278.36
329632297482969082.09
428668287972873279.44
528216282682824278.08
631153311173113586.08
厄贝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100607-201804对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.022059534206239420578622053493205757120581710.16
215.082053667205717620554220.13
单位质量响应值RSD%判断
137028.70136301.190.38数据可信
影响因素30天-供试品溶液-厄贝沙坦-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024042411批裸放高温117796541766629177314277.8580.021.8978.43%～81.60%
218054231796405180091479.07
318058601804350180510579.25
418636951853943185881981.61
518518331851140185148681.29
618499051841239184557281.03
2024042411批裸放高湿116707781677448167411373.5071.781.4770.67%～72.88%
216204461627526162398671.30
316177831614553161616870.96
416457741645791164578272.26
516395421641699164062072.03
616091731607595160838470.61
2024042411批裸放光照117869651785028178599678.4179.081.3377.99%～80.18%
218322901814065182317880.04
318294001830439182992080.34
417843921787337178586478.41
517717511769411177058177.73
618184971806214181235679.57
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