替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00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%
111.235027845031385044235030845029985032850.13
211.255038725042325040520.06
单位质量响应值RSD%判断
44816.1244804.620.02数据可信
供试品溶液-24121101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%
5min1171886-17188634.52337.0810.3634.5237.0810.36
2160276-16027632.19132.19
3195651-19565139.29639.30
4173850-17385034.91734.92
5211957-21195742.57142.57
6194027-19402738.97038.97
10min1339792-33979268.24671.4310.3868.4471.6410.38
2316369-31636963.54263.72
3366306-36630673.57173.79
4319157-31915764.10264.30
5384046-38404677.13477.37
6408216-40821681.98982.21
15min1447313-44731389.84189.125.5690.4189.725.58
2415973-41597383.54784.08
3440582-44058288.48989.12
4416501-41650183.65384.20
5467563-46756393.90894.57
6474305-47430595.26295.93
20min1460603-46060392.51094.191.4893.5895.291.51
2462764-46276492.94493.94
3475875-47587595.57896.70
4470053-47005394.40895.42
5477687-47768795.94297.13
6466757-46675793.74694.95
30min1465490-46549093.49295.021.2895.0896.641.23
2475290-47529095.46096.97
3476413-47641395.68697.34
4480295-48029596.46698.00
5475186-47518695.43997.16
6465815-46581593.55795.28
45min1477978-47797896.00095.831.7698.1097.981.65
2484529-48452997.31699.36
3481978-48197896.80498.98
4481937-48193796.79598.87
5474639-47463995.33097.58
6461613-46161392.71394.96
60min1464701-46470193.33494.230.9495.9796.910.92
2474990-47499095.40097.98
3468285-46828594.05396.77
4467906-46790693.97796.59
5474028-47402895.20797.99
6465012-46501293.39696.15
极限1471265-47126594.65293.082.0497.8196.281.90
2475933-47593395.58998.70
3456384-45638491.66394.90
4466069-46606993.60896.74
5460080-46008092.40595.71
6450861-45086190.55493.83
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