富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.101682951685061683161686201685051684480.09
210.081682971685121684040.10
单位质量响应值RSD%判断
16678.0216706.750.13数据可信
供试品溶液-25020401批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1183753-18375398.87698.791.7498.8898.791.74
2183604-18360498.79698.80
3184246-18424699.14199.14
4187961-187961101.140101.14
5178009-17800995.78595.78
6183953-18395398.98398.98
10min1188601-188601101.48499.811.97101.6599.981.97
2183755-18375598.87799.04
3185198-18519899.65399.82
4190186-190186102.337102.51
5179885-17988596.79496.95
6185339-18533999.72999.89
15min1188179-188179101.25799.551.56101.5999.881.56
2184017-18401799.01899.35
3184499-18449999.27799.61
4188139-188139101.236101.57
5180510-18051097.13197.45
6184697-18469799.38499.71
20min1188436-188436101.39699.201.92101.9099.701.92
2183175-18317598.56599.06
3183918-18391898.96499.46
4187721-187721101.011101.52
5178644-17864496.12796.61
6184243-18424399.13999.64
30min1186844-186844100.53998.841.83101.2199.501.83
2182309-18230998.09998.76
3183310-18331098.63799.30
4187508-187508100.896101.57
5178254-17825495.91796.56
6183853-18385398.92999.59
45min1185288-18528899.70298.121.79100.5498.951.79
2181474-18147497.64998.47
3182039-18203997.95398.78
4185976-185976100.072100.92
5176845-17684595.15995.96
6182461-18246198.18099.01
极限1184166-18416699.09897.651.80100.1098.641.80
2180632-18063297.19698.18
3180880-18088097.33098.32
4185292-18529299.704100.71
5175986-17598694.69695.66
6181861-18186197.85898.85
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