乌帕替尼片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941713801714321712501709181719521713860.22
214.991713881711201712540.12
单位质量响应值RSD%判断
11471.6211424.550.30数据可信
供试品溶液-2025081121批-0.05yc
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min113548-135487.0647.164.957.067.164.97
213033-130336.7956.80
313006-130066.7816.78
413843-138437.2177.22
514209-142097.4087.41
614741-147417.6867.69
30min128705-2870514.96614.593.7014.9814.603.69
227458-2745814.31614.33
326326-2632613.72613.74
427731-2773114.45814.47
528411-2841114.81314.83
629233-2923315.24215.25
45min139899-3989920.80320.722.5520.8420.762.56
239646-3964620.67120.71
338202-3820219.91819.95
439167-3916720.42120.46
540320-4032021.02221.06
641176-4117621.46821.51
60min150451-5045126.30426.002.4926.3826.072.49
249939-4993926.03726.11
347842-4784224.94425.01
449125-4912525.61325.68
550522-5052226.34126.41
651365-5136526.78126.85
75min159385-5938530.96230.782.1631.0830.902.17
259035-5903530.78030.89
357046-5704629.74329.85
458227-5822730.35930.47
559865-5986531.21331.33
660678-6067831.63631.76
90min167429-6742935.15635.041.8635.3235.211.86
267595-6759535.24335.41
365227-6522734.00834.17
466305-6630534.57034.73
568105-6810535.50935.68
668622-6862235.77835.95
105min174952-7495239.07938.921.9239.3039.151.92
274596-7459638.89339.12
372460-7246037.77937.99
473782-7378238.46938.69
575565-7556539.39839.63
676571-7657139.92340.15
120min181793-8179342.64542.411.8642.9442.701.87
281453-8145342.46842.76
378875-7887541.12441.40
480608-8060842.02842.31
581956-8195642.73043.02
683393-8339343.48043.78
极限187915-8791545.83745.691.0546.2046.051.06
287519-8751945.63145.99
386524-8652445.11245.46
486665-8666545.18645.54
588271-8827146.02346.39
688869-8886946.33546.70
乌帕替尼片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941704891706351709451710431709191708060.14
214.991706551703281704920.14
单位质量响应值RSD%判断
11432.8011373.720.37数据可信
供试品溶液-1270307批-0.05yc
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min114939-149397.8207.802.007.827.801.98
214855-148557.7767.78
314558-145587.6207.62
414810-148107.7527.75
514763-147637.7277.73
615443-154438.0838.08
30min127754-2775414.52714.372.1614.5414.382.17
227738-2773814.51914.53
327942-2794214.62614.64
426897-2689714.07914.09
526539-2653913.89113.90
627889-2788914.59814.61
45min137799-3779919.78519.841.0819.8219.881.07
238060-3806019.92219.96
338296-3829620.04520.08
437765-3776519.76719.80
537222-3722219.48319.52
638295-3829520.04520.08
60min146735-4673524.46324.571.2624.5324.641.25
247213-4721324.71324.78
347777-4777725.00825.08
446862-4686224.52924.60
546000-4600024.07824.15
647070-4707024.63824.71
75min154318-5431828.43228.821.5628.5428.941.57
255107-5510728.84528.96
356652-5665229.65429.77
455121-5512128.85228.96
554322-5432228.43428.54
654875-5487528.72328.84
90min161181-6118132.02432.651.6432.1832.811.64
262858-6285832.90233.06
363872-6387233.43333.59
462971-6297132.96133.12
561591-6159132.23932.39
661789-6178932.34232.50
105min167917-6791735.55036.161.3335.7636.371.33
269103-6910336.17136.39
370422-7042236.86137.08
469759-6975936.51436.73
568329-6832935.76635.98
668929-6892936.08036.29
120min174363-7436338.92439.932.2139.2040.202.19
275473-7547339.50539.78
377470-7747040.55040.83
476431-7643140.00740.28
578906-7890641.30241.57
675050-7505039.28439.56
极限179186-7918641.44942.481.5541.7842.821.56
281899-8189942.86943.21
382837-8283743.36043.71
481594-8159442.70943.05
580614-8061442.19642.53
680769-8076942.27742.62
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