氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83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0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.89 1782561783841786021784371784961784350.08
213.89 1790301795131792720.20
单位质量响应值RSD%判断
12846.2912906.550.34数据可信
供试品溶液-2757904批-枸橼酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min120031-2003110.9969.6736.6811.009.6736.70
217445-174459.5769.58
39842-98425.4035.40
428813-2881315.81615.82
515436-154368.4738.47
614118-141187.7507.75
5min180570-8057044.22848.706.5344.2348.706.53
288878-8887848.78848.79
384292-8429246.27146.27
488359-8835948.50348.50
595293-9529352.31052.31
694917-9491752.10352.10
10min1118730-11873065.17571.615.6565.1771.615.65
2131606-13160672.24372.24
3133612-13361273.34473.34
4125128-12512868.68768.69
5134275-13427573.70873.71
6139364-13936476.50276.50
15min1130171-13017171.45579.156.2071.4679.146.20
2150383-15038382.55082.55
3143076-14307678.53978.54
4137616-13761675.54275.54
5151479-15147983.15283.15
6152356-15235683.63383.63
20min1139397-13939776.52084.136.0776.5284.136.07
2161478-16147888.64188.64
3157616-15761686.52186.52
4143646-14364678.85278.85
5158041-15804186.75486.75
6159429-15942987.51687.52
30min1150266-15026682.48688.864.8482.4988.864.84
2170294-17029493.48093.48
3166035-16603591.14291.14
4154142-15414284.61484.61
5165208-16520890.68890.69
6165333-16533390.75790.76
45min1157582-15758286.50292.234.8286.5092.234.82
2176510-17651096.89296.89
3172357-17235794.61394.61
4158124-15812486.80086.80
5172514-17251494.69994.70
6171050-17105093.89593.90
60min1161376-16137688.58592.914.5288.5892.914.52
2175949-17594996.58496.58
3176535-17653596.90696.91
4158881-15888187.21587.22
5174120-17412095.58095.58
6168644-16864492.57492.57
极限1158696-15869687.11493.384.5687.1193.384.56
2178437-17843797.95097.95
3174396-17439695.73295.73
4162604-16260489.25989.26
5174902-17490296.01096.01
6171674-17167494.23894.24
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