盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.882062402064742066342070362071512067070.19
215.952078662081882080270.11
单位质量响应值RSD%判断
13016.8113042.450.14数据可信
供试品溶液-2024042721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%
5min111358-113585.84113.3341.035.8413.3341.04
222565-2256511.60411.60
320852-2085210.72310.72
440740-4074020.95120.95
535630-3563018.32318.32
624371-2437112.53312.53
10min185922-8592244.18648.819.6944.2248.889.69
2101928-10192852.41752.48
384071-8407143.23443.29
490568-9056846.57546.69
5101363-10136352.12652.23
6105595-10559554.30254.37
15min1114996-11499659.13760.107.1559.4160.447.15
2125654-12565464.61864.97
3104822-10482253.90554.20
4110051-11005156.59456.97
5124328-12432863.93664.33
6121386-12138662.42362.79
20min1113523-11352358.37962.887.0858.9963.567.09
2131319-13131967.53168.25
3114091-11409158.67159.27
4117688-11768860.52161.21
5133494-13349468.64969.40
6123498-12349863.50964.23
30min1125547-12554764.56366.646.1565.4967.666.18
2137256-13725670.58471.67
3118887-11888761.13862.06
4123964-12396463.74964.77
5138744-13874471.34972.48
6133079-13307968.43669.51
45min1128561-12856166.11367.895.3467.4069.285.38
2138209-13820971.07472.56
3122420-12242062.95564.22
4127220-12722065.42366.80
5140564-14056472.28573.81
6135092-13509269.47170.92
60min1128151-12815165.90268.806.4367.5670.586.44
2141445-14144572.73874.62
3123712-12371263.61965.23
4127708-12770865.67467.42
5145361-14536174.75276.68
6136327-13632770.10671.94
极限1134709-13470969.27469.885.8371.3072.045.81
2142306-14230673.18175.46
3130350-13035067.03369.00
4123584-12358463.55365.66
5144307-14430774.21076.55
6140049-14004972.02074.25
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