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)5
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%
111.137530137538107534537538467554737539190.13
211.167515167512667513910.03
单位质量响应值RSD%判断
67737.5667328.940.43数据可信
供试品溶液-2023052121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1206860-20686027.56829.404.3727.5729.404.36
2235103-23510331.33231.33
3225857-22585730.10030.10
4221033-22103329.45729.46
5220239-22023929.35129.35
6214576-21457628.59628.60
10min1425480-42548056.70357.604.6656.8657.764.66
2471207-47120762.79762.97
3430627-43062757.38957.56
4428175-42817557.06257.23
5425485-42548556.70456.87
6412262-41226254.94255.10
15min1608538-60853881.09978.354.4181.5778.834.40
2628081-62808183.70484.23
3586427-58642778.15278.64
4563825-56382575.14075.62
5562974-56297475.02775.51
6577420-57742076.95277.42
20min1707571-70757194.29793.813.3695.2294.733.36
2746325-74632599.462100.45
3690950-69095092.08293.00
4684491-68449191.22192.12
5684245-68424591.18992.08
6710101-71010194.63495.53
30min1745916-74591699.407102.322.58100.85103.762.55
2786743-786743104.848106.39
3759253-759253101.185102.62
4790942-790942105.408106.81
5776670-776670103.506104.91
6747220-74722099.581101.00
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)5
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%
111.137532047532537527847530977529947530660.03
211.167497927473917485920.23
单位质量响应值RSD%判断
67660.9267078.140.62数据可信
供试品溶液-2023052121批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190178-19017825.40727.976.4225.4127.976.43
2215091-21509128.73528.73
3206621-20662127.60327.60
4200414-20041426.77426.77
5228872-22887230.57630.58
6215170-21517028.74528.75
10min1371333-37133349.60853.605.1749.7553.755.18
2416034-41603455.58055.74
3392159-39215952.39052.54
4387045-38704551.70751.86
5424016-42401656.64656.82
6416554-41655455.64955.81
15min1514162-51416268.68974.816.2069.1175.276.19
2587260-58726078.45478.92
3528148-52814870.55771.00
4549370-54937073.39373.83
5599838-59983880.13580.62
6581212-58121277.64678.12
20min1641299-64129985.67491.022.9786.4791.892.99
2685572-68557291.58892.49
3690453-69045392.24093.08
4682457-68245791.17292.02
5692085-69208592.45893.39
6696200-69620093.00893.91
30min1728105-72810597.27198.992.9198.54100.372.91
2727724-72772497.22098.63
3746372-74637299.711101.06
4721663-72166396.41097.76
5780686-780686104.295105.74
6741471-74147199.056100.47
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