乌帕替尼缓释片 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%
115.111782891783881782371783811779481782490.11
215.111772421767221769820.21
单位质量响应值RSD%判断
11796.7611712.910.51数据可信
供试品溶液-1234026批-15mg规格-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%
15min119162-191629.7309.614.019.739.624.03
217889-178899.0849.08
319930-1993010.12010.12
419175-191759.7379.74
518179-181799.2319.23
619271-192719.7859.79
30min133941-3394117.23517.203.7517.2517.223.75
232330-3233016.41716.43
335816-3581618.18718.20
433836-3383617.18117.20
532715-3271516.61216.63
634626-3462617.58217.60
45min145855-4585523.28423.393.1723.3323.433.16
244363-4436322.52722.57
348283-4828324.51724.56
445846-4584623.28023.32
544850-4485022.77422.82
647171-4717123.95324.00
60min156023-5602328.44728.592.8328.5328.682.83
254699-5469927.77527.86
358755-5875529.83529.92
456270-5627028.57328.66
554647-5464727.74927.83
657436-5743629.16529.25
75min165299-6529933.15833.162.3733.2933.292.37
263816-6381632.40532.53
367831-6783134.44334.58
465001-6500133.00633.14
563730-6373032.36132.49
666162-6616233.59633.73
90min173599-7359937.37237.421.9637.5637.601.96
273795-7379537.47237.65
375998-7599838.59038.79
472884-7288437.00937.20
571663-7166336.38936.57
674168-7416837.66137.85
105min181366-8136641.31641.101.9641.5641.351.96
279636-7963640.43840.68
383393-8339342.34542.60
480022-8002240.63440.88
579278-7927840.25640.50
681973-8197341.62441.88
120min188075-8807544.72344.862.0745.0445.182.06
287109-8710944.23244.54
390295-9029545.85046.18
487382-8738244.37144.69
586370-8637043.85744.17
690862-9086246.13846.46
极限196620-9662049.06247.921.9849.4548.311.98
292746-9274647.09547.48
396229-9622948.86349.27
493444-9344447.44947.84
592141-9214146.78747.17
695031-9503148.25548.65
乌帕替尼缓释片 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%
115.111784741785821786421790301783681786190.15
215.111782111782041782080.01
单位质量响应值RSD%判断
11821.2411794.040.17数据可信
供试品溶液-1234026批-15mg规格-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%
15min118581-185819.3939.371.879.399.371.87
218020-180209.1099.11
318370-183709.2869.29
419084-190849.6479.65
518570-185709.3879.39
618537-185379.3719.37
30min133718-3371817.04517.031.3317.0617.051.35
232917-3291716.64016.65
333855-3385517.11417.13
433481-3348116.92516.94
534145-3414517.26017.28
634048-3404817.21117.23
45min145943-4594323.22423.120.7623.2723.160.76
245128-4512822.81222.86
345525-4552523.01323.06
445772-4577223.13823.18
546040-4604023.27323.32
645960-4596023.23323.28
60min156215-5621528.41728.641.5628.5028.721.54
258225-5822529.43329.51
355735-5573528.17428.26
456929-5692928.77828.86
556723-5672328.67428.76
656110-5611028.36428.45
75min165446-6544633.08333.050.7433.2133.180.75
265343-6534333.03133.16
364955-6495532.83532.96
464872-6487232.79332.92
566227-6622733.47833.61
665407-6540733.06333.19
90min173544-7354437.17737.070.7737.3637.260.77
273279-7327937.04337.23
372938-7293836.87037.05
472861-7286136.83237.02
574362-7436237.59037.78
673049-7304936.92737.11
105min181463-8146341.18041.281.6841.4341.531.68
280854-8085440.87241.12
380604-8060440.74640.99
480549-8054940.71840.96
582492-8249241.70041.95
684035-8403542.48042.73
120min188397-8839744.68544.640.8645.0044.950.86
288404-8840444.68945.00
387887-8788744.42744.74
487376-8737644.16944.48
589634-8963445.31045.63
688103-8810344.53644.85
极限194084-9408447.56047.480.7347.9547.870.73
294385-9438547.71248.10
393207-9320747.11647.50
493263-9326347.14547.53
594950-9495047.99848.39
693711-9371147.37147.76
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