盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
1 11.101940241930761947491943561935941939600.34
2 11.081923511916901920200.25
单位质量响应值RSD%判断
17473.8717330.320.59数据可信
供试品溶液-2025011721批-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%
15min142244-4224421.79121.984.6021.7921.984.59
244723-4472323.07023.07
340861-4086121.07821.08
5min143607-4360722.49423.244.3922.5323.284.39
247306-4730624.40224.44
344244-4424422.82322.86
10min158301-5830130.07430.152.9930.1530.222.99
260250-6025031.08031.16
356767-5676729.28329.36
20min160066-6006630.98531.542.1931.1131.662.19
262630-6263032.30732.44
360709-6070931.31631.44
30min165947-6594734.01834.403.1634.1934.583.16
269069-6906935.62935.81
365058-6505833.56033.73
45min167614-6761434.87835.431.8735.1135.661.89
270105-7010536.16336.41
368323-6832335.24435.47
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
1 11.101949061945561946531943061938041944450.22
2 11.081946981920541933760.97
单位质量响应值RSD%判断
17517.5717452.710.27数据可信
供试品溶液-2025011721批-mnpH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min1467569-467569240.044237.931.23240.04237.931.23
2465821-465821239.146239.15
3456949-456949234.591234.59
5min1415938-415938213.537213.060.34213.94213.460.34
2415695-415695213.412213.81
3413422-413422212.245212.64
10min132941-3294116.91117.8413.4217.6718.6012.85
231269-3126916.05316.81
340049-4004920.56121.31
20min114494-144947.4417.402.538.238.192.31
214739-147397.5678.35
314022-140227.1997.98
30min120506-2050610.52810.2815.8711.3211.0814.71
216640-166408.5439.34
322940-2294011.77712.57
45min113302-133026.8296.529.727.647.348.62
213534-135346.9487.76
311290-112905.7966.61
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