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0100320240115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%
111.174964774964344963584967714966484965380.04
211.264968404964434966420.06
单位质量响应值RSD%判断
44452.8244106.750.56数据可信
供试品溶液-24110101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%
5min197404-9740419.79820.213.2319.8020.213.22
297343-9734319.78619.79
3105637-10563721.47121.47
499635-9963520.25120.25
597358-9735819.78919.79
699286-9928620.18020.18
10min1171883-17188334.93634.661.6035.0534.771.61
2167113-16711333.96734.08
3174593-17459335.48735.61
4171582-17158234.87534.99
5168256-16825634.19934.31
6169684-16968434.48934.60
15min1223592-22359245.44645.581.9945.7545.881.98
2217477-21747744.20444.50
3226629-22662946.06446.38
4230785-23078546.90847.21
5222240-22224045.17245.47
6224807-22480745.69346.00
20min1266819-26681954.23354.262.6554.7954.822.62
2261278-26127853.10653.65
3266171-26617154.10154.67
4265364-26536453.93754.50
5261538-26153853.15953.71
6280517-28051757.01757.57
30min1338638-33863868.83069.052.1169.6969.902.10
2337096-33709668.51769.36
3347149-34714970.56071.43
4345222-34522270.16871.03
5327347-32734766.53567.38
6342756-34275669.66770.54
45min1404321-40432182.18186.283.6083.4287.523.56
2416722-41672284.70185.92
3438914-43891489.21290.48
4445728-44572890.59791.85
5422244-42224485.82487.04
6419001-41900185.16586.43
60min1457736-45773693.03897.072.9494.7398.792.92
2468196-46819695.16496.85
3481052-48105297.77799.54
4485790-48579098.740100.50
5474686-47468696.48398.18
6497920-497920101.205102.94
极限1467908-46790895.10598.362.5697.32100.622.54
2485096-48509698.599100.82
3483285-48328598.231100.53
4490811-49081199.760102.07
5473705-47370596.28398.51
6502805-502805102.198104.49
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