乌帕替尼项目信息
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%
115.331758281760941764641757581756821759650.19
215.311766091770261768180.17
单位质量响应值RSD%判断
11478.4711549.180.44数据可信
供试品溶液-2025081121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%
15min116490-164908.5498.135.688.558.125.71
215032-150327.7937.79
316339-163398.4708.47
416566-165668.5888.59
515086-150867.8217.82
614533-145337.5347.53
30min131510-3151016.33515.903.9516.3515.913.95
230227-3022715.67015.68
331970-3197016.57316.59
431458-3145816.30816.32
530081-3008115.59415.61
628730-2873014.89414.91
45min143423-4342322.51122.183.2822.5522.223.29
242804-4280422.19022.23
344242-4424222.93522.98
443795-4379522.70422.75
541986-4198621.76621.80
640415-4041520.95120.99
60min153265-5326527.61327.452.9927.6927.532.99
253772-5377227.87627.95
354093-5409328.04228.12
454457-5445728.23128.31
551831-5183126.87026.94
650320-5032026.08626.16
75min161886-6188632.08232.072.5232.2132.202.52
263233-6323332.78032.90
362903-6290332.60932.74
462960-6296032.63932.77
561053-6105331.65031.77
659165-5916530.67230.79
90min169863-6986336.21836.603.7336.4036.783.73
271423-7142337.02637.20
374567-7456738.65638.84
471819-7181937.23237.41
569053-6905335.79835.97
666892-6689234.67734.84
105min176693-7669339.75840.102.4140.0040.342.41
278448-7844840.66840.91
378919-7891940.91241.16
479289-7928941.10441.35
576346-7634639.57839.81
674443-7444338.59238.82
120min183579-8357943.32843.632.2743.6343.942.27
285520-8552044.33444.64
385575-8557544.36344.68
486062-8606244.61544.93
583191-8319143.12743.43
681087-8108742.03642.33
极限189351-8935146.32046.632.2646.7047.012.26
291272-9127247.31647.70
391252-9125247.30647.69
492072-9207247.73148.12
589273-8927346.28046.65
686516-8651644.85145.21
乌帕替尼项目信息
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%
115.331768521761331764441763281762631764040.16
215.311757181759721758450.11
单位质量响应值RSD%判断
11507.1111485.630.14数据可信
供试品溶液-1270307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%
15min117093-170938.8759.4314.928.879.4314.94
223626-2362612.26612.27
317875-178759.2819.28
416826-168268.7368.74
516663-166638.6518.65
616901-169018.7758.77
30min130789-3078915.98516.248.1416.0016.268.12
229489-2948915.31015.33
336382-3638218.88918.90
430173-3017315.66615.68
530046-3004615.60015.61
630838-3083816.01116.03
45min141114-4111421.34621.412.3721.3921.462.37
240580-4058021.06921.11
342827-4282722.23522.28
440499-4049921.02721.07
540432-4043220.99221.03
642008-4200821.81021.85
60min150495-5049526.21726.282.9326.2926.362.93
249558-4955825.73025.81
353034-5303427.53527.62
449539-4953925.72025.80
549380-4938025.63825.71
651740-5174026.86326.94
75min158789-5878930.52330.692.9730.6430.812.97
258009-5800930.11830.24
360868-6086831.60231.73
457926-5792630.07530.19
557360-5736029.78129.90
661664-6166432.01532.14
90min166629-6662934.59334.892.1034.7635.062.10
265651-6565134.08534.26
368933-6893335.78935.97
465658-6565834.08934.26
568223-6822335.42135.59
668082-6808235.34835.52
105min174288-7428838.57038.282.3238.8038.522.32
272623-7262337.70537.94
376314-7631439.62139.86
472677-7267737.73337.96
571707-7170737.23037.46
674830-7483038.85139.09
120min179454-7945441.25241.962.8541.5542.262.84
282918-8291843.05043.34
383373-8337343.28643.59
479272-7927241.15741.45
577757-7775740.37140.66
682192-8219242.67342.97
极限185069-8506944.16744.812.2544.5345.172.25
287415-8741545.38545.75
388740-8874046.07346.45
485319-8531944.29744.65
583597-8359743.40343.76
687654-8765445.50945.88
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