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%
111.115060605080995070795068225064325068980.16
211.195067655100465084060.46
单位质量响应值RSD%判断
45625.3845433.960.30数据可信
供试品溶液-24102901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%
5min1100291-10029119.82521.557.7219.8221.557.72
2124054-12405424.52224.52
3102833-10283320.32720.33
4111923-11192322.12422.12
5107737-10773721.29721.30
6107180-10718021.18721.19
10min1173094-17309434.21634.933.6434.3335.053.64
2188281-18828137.21837.35
3171055-17105533.81333.93
4178163-17816335.21835.34
5177756-17775635.13835.26
6171797-17179733.96034.08
15min1237863-23786347.01946.113.4047.3246.423.38
2241345-24134547.70848.05
3240912-24091247.62247.92
4227290-22729044.92945.25
5222270-22227043.93744.25
6229851-22985145.43645.74
20min1282053-28205355.75555.737.8556.3256.307.79
2291028-29102857.52958.14
3321287-32128763.51064.08
4263970-26397052.18052.75
5263282-26328252.04452.60
6269854-26985453.34353.90
30min1404909-40490980.04078.594.6380.9179.474.60
2379797-37979775.07676.00
3429786-42978684.95885.88
4384835-38483576.07276.93
5399595-39959578.99079.84
6386608-38660876.42277.28
45min1470659-47065993.03794.181.1994.3595.501.20
2479983-47998394.88096.22
3483471-48347195.57096.96
4476795-47679594.25095.53
5468915-46891592.69293.98
6478897-47889794.66695.95
60min1482635-48263595.40493.921.9697.2495.761.94
2480119-48011994.90796.78
3477577-47757794.40596.33
4468698-46869892.64994.45
5459327-45932790.79792.60
6482272-48227295.33397.14
极限1483580-48358095.59194.431.9297.9596.781.90
2477458-47745894.38196.78
3481724-48172495.22497.67
4470566-47056693.01995.34
5463837-46383791.68993.99
6488920-48892096.64798.98
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