精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.863178883177353175033179063178633177790.06
29.923193963194243194100.01
单位质量响应值RSD%判断
32229.1132198.590.07数据可信
长期6月-供试品溶液-pH2.0盐酸溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023091921118350618345218347997.1998.002.5495.40%~100.61%
2188890188842188866100.04
318445418441418443497.70
4189512189372189442100.35
517679917667317673693.62
618717818708418713199.13
20230920211189294189487189390100.3299.981.0598.89%~101.08%
2191592191557191574101.48
318613018637618625398.66
418666218679718673098.91
5189537189503189520100.39
6189018189061189040100.14
2023092022118845918846818846499.83100.351.4198.88%~101.83%
218570618577018573898.39
3188988189017189002100.12
4191052191240191146101.25
518881418872518877099.99
6193507193646193576102.54
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