达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.311984011990641981891997601992731989370.33
212.272001881982871992380.68
单位质量响应值RSD%判断
16160.6016237.820.34数据可信
供试品溶液-WA3063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%
5min1127873-12787363.46668.288.3063.4768.288.30
2119187-11918759.15559.16
3142642-14264270.79770.80
4142442-14244270.69770.70
5145120-14512072.02672.03
6148186-14818673.54873.55
10min1161981-16198180.39584.535.9680.4984.635.96
2162660-16266080.73280.82
3163177-16317780.98981.09
4177062-17706287.88087.99
5169705-16970584.22984.34
6187304-18730492.96393.07
15min1167317-16731783.04388.275.5383.2688.505.53
2178610-17861088.64888.86
3169050-16905083.90384.13
4183434-18343491.04391.28
5174853-17485386.78487.02
6193783-19378396.17996.43
20min1168982-16898283.87090.695.1684.2191.055.16
2188154-18815493.38593.73
3174835-17483586.77587.13
4184974-18497491.80792.18
5184184-18418491.41591.78
6195214-19521496.88997.28
30min1175569-17556987.13993.454.5787.6193.954.56
2193795-19379596.18596.67
3180613-18061389.64290.13
4188554-18855493.58494.10
5193264-19326495.92196.42
6197949-19794998.24798.79
45min1185320-18532091.97995.033.1792.5895.663.17
2195598-19559897.08097.71
3184474-18447491.55992.18
4188968-18896893.78994.44
5195201-19520196.88397.53
6199200-19920098.86899.55
60min1191284-19128494.93995.902.6695.6796.682.66
2196934-19693497.74398.52
3185330-18533091.98492.74
4190297-19029794.44995.24
5196778-19677897.66698.46
6198745-19874598.64299.48
极限1199165-19916598.85098.151.2399.7399.081.23
2197041-19704197.79698.72
3193837-19383796.20697.10
4200868-20086899.695100.63
5196857-19685797.70598.64
6198801-19880198.67099.65
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