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%
115.331797611791921792281793961787221792600.21
215.311794621799761797190.21
单位质量响应值RSD%判断
11693.4111738.670.28数据可信
供试品溶液-2025081121批-含5%乙醇pH1.2盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min113877-138777.0707.216.867.077.216.87
215354-153547.8227.82
314602-146027.4397.44
414586-145867.4317.43
513968-139687.1167.12
612489-124896.3636.36
30min127704-2770414.11414.345.8614.1314.365.87
229748-2974815.15515.17
329823-2982315.19415.21
428806-2880614.67514.69
527324-2732413.92013.93
625515-2551512.99913.01
45min139764-3976420.25820.304.2220.2920.334.23
241615-4161521.20121.24
341211-4121120.99521.03
440566-4056620.66720.70
538816-3881619.77519.81
637099-3709918.90018.93
60min150061-5006125.50425.583.6525.5725.653.66
252278-5227826.63326.71
351702-5170226.34026.41
450944-5094425.95426.03
548949-4894924.93725.01
647361-4736124.12824.19
75min159213-5921330.16630.113.3430.2830.223.34
261519-6151931.34131.46
360393-6039330.76830.88
459826-5982630.47930.59
557659-5765929.37529.48
656047-5604728.55428.66
90min167727-6772734.50434.173.1034.6734.343.11
269240-6924035.27535.45
368800-6880035.05135.22
467636-6763634.45834.62
564813-6481333.01933.18
664248-6424832.73232.88
105min174899-7489938.15838.514.4438.3838.734.43
279041-7904140.26840.50
376744-7674439.09839.32
479251-7925140.37540.60
571830-7183036.59436.81
671740-7174036.54836.75
120min181845-8184541.69741.353.0241.9841.633.02
283719-8371942.65142.95
383233-8323342.40442.70
481795-8179541.67141.96
577732-7773239.60139.88
678621-7862140.05440.32
极限187058-8705844.35244.332.7044.7044.692.71
289641-8964145.66846.04
389199-8919945.44345.81
487678-8767844.66845.03
583924-8392442.75643.10
684616-8461643.10843.44
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%
115.331794201793171789951794561793501793080.11
215.311797831800381799100.11
单位质量响应值RSD%判断
11696.5411751.140.33数据可信
供试品溶液-1270307批-含20%乙醇pH1.2盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min114464-144647.3647.533.057.367.533.04
215007-150077.6407.64
315279-152797.7797.78
414872-148727.5727.57
514060-140607.1587.16
615072-150727.6737.67
30min125983-2598313.22813.833.7713.2413.843.76
228794-2879414.66014.67
327479-2747913.99014.00
427058-2705813.77613.79
526197-2619713.33713.35
627518-2751814.01014.02
45min135841-3584118.24719.063.3118.2819.093.31
238244-3824419.47119.51
339117-3911719.91519.95
437376-3737619.02919.06
536213-3621318.43718.47
637805-3780519.24719.28
60min144637-4463722.72623.752.5922.7923.812.59
247287-4728724.07524.14
348247-4824724.56324.63
446838-4683823.84623.91
546154-4615423.49823.56
646706-4670623.77923.85
75min152515-5251526.73627.772.9226.8427.872.92
256069-5606928.54628.66
356448-5644828.73928.85
454580-5458027.78827.89
552943-5294326.95427.06
654667-5466727.83227.94
90min160461-6046130.78231.591.9930.9331.741.99
262235-6223531.68531.84
364004-6400432.58632.74
462451-6245131.79531.95
561020-6102031.06631.22
662100-6210031.61631.77
105min167162-6716234.19335.032.1634.3935.232.16
268787-6878735.02135.23
371102-7110236.19936.41
469371-6937135.31835.52
567199-6719934.21234.41
669174-6917435.21835.42
120min173492-7349237.41638.232.0037.6738.492.00
275059-7505938.21438.48
377584-7758439.49939.77
475265-7526538.31938.58
573588-7358837.46537.72
675518-7551838.44838.71
极限179212-7921240.32841.141.9340.6541.461.94
280651-8065141.06141.39
383436-8343642.47942.82
481230-8123041.35641.68
579244-7924440.34540.66
681013-8101341.24541.57
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%
115.331796881797061796381795231797181796550.05
215.311793021788851790940.17
单位质量响应值RSD%判断
11719.1811697.840.13数据可信
供试品溶液-2025081121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min110259-102595.2305.473.055.235.463.04
211033-110335.6245.62
310589-105895.3985.40
410478-104785.3425.34
511046-110465.6315.63
610922-109225.5685.57
30min121873-2187311.15011.898.8711.1611.908.86
223141-2314111.79711.81
321995-2199511.21311.22
427407-2740713.97213.98
522458-2245811.44911.46
623096-2309611.77411.78
45min132203-3220316.41716.801.7116.4416.821.71
233184-3318416.91716.95
332605-3260516.62116.65
432908-3290816.77616.81
532916-3291616.78016.81
633868-3386817.26517.29
60min141321-4132121.06521.482.4021.1221.542.41
242052-4205221.43721.49
341320-4132021.06421.12
442498-4249821.66521.72
541631-4163121.22321.28
643976-4397622.41822.48
75min149054-4905425.00725.431.6725.1025.531.67
250305-5030525.64525.74
349152-4915225.05725.15
450662-5066225.82725.92
549268-4926825.11625.21
650916-5091625.95626.05
90min155879-5587928.48629.111.9328.6229.241.93
257817-5781729.47429.61
356157-5615728.62828.76
457910-5791029.52229.66
556342-5634228.72228.86
658477-5847729.81129.95
105min162701-6270131.96432.752.5332.1432.932.53
264127-6412732.69132.88
363156-6315632.19632.38
465050-6505033.16133.35
563325-6332532.28232.46
667094-6709434.20334.39
120min169013-6901335.18235.671.5535.4135.911.56
270203-7020335.78836.03
368693-6869335.01935.25
470764-7076436.07436.32
569614-6961435.48835.72
671553-7155336.47736.72
极限174382-7438237.91938.421.4738.2138.721.47
275397-7539738.43638.74
374255-7425537.85438.15
476076-7607638.78239.09
574978-7497838.22338.52
677157-7715739.33339.64
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%
115.331791861794521799151786161795281793390.27
215.311796271794761795520.06
单位质量响应值RSD%判断
11698.5611727.760.18数据可信
供试品溶液-1270307批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min111480-114805.8506.082.985.856.082.97
212266-122666.2516.25
312368-123686.3036.30
411784-117846.0056.00
511636-116365.9295.93
612047-120476.1396.14
30min121768-2176811.09311.623.8811.1011.633.89
224347-2434712.40712.42
323046-2304611.74411.75
422312-2231211.37011.38
522437-2243711.43311.44
622940-2294011.69011.70
45min130280-3028015.43016.062.5915.4616.092.59
232585-3258516.60516.64
331965-3196516.28916.32
430910-3091015.75115.78
531644-3164416.12516.15
631742-3174216.17516.20
60min137850-3785019.28820.012.4019.3420.072.40
240495-4049520.63520.69
339916-3991620.34020.40
438638-3863819.68919.74
539195-3919519.97320.03
639554-3955420.15620.21
75min145074-4507422.96923.652.2423.0523.742.25
247518-4751824.21424.31
346457-4645723.67423.76
445331-4533123.10023.19
547484-4748424.19724.29
646656-4665623.77523.87
90min151018-5101825.99826.792.3126.1226.922.31
254433-5443327.73827.87
352406-5240626.70526.84
451640-5164026.31526.44
552571-5257126.78926.92
653332-5333227.17727.31
105min157689-5768929.39730.031.7829.5630.201.79
260463-6046330.81130.99
358700-5870029.91230.09
458025-5802529.56829.74
558914-5891430.02130.20
659784-5978430.46530.64
120min162904-6290432.05532.771.7232.2732.991.73
265813-6581333.53733.77
364411-6441132.82333.05
463387-6338732.30132.52
564030-6403032.62832.85
665280-6528033.26533.49
极限167756-6775634.52735.321.7434.8035.601.75
271080-7108036.22136.51
369486-6948635.40935.69
468581-6858134.94835.22
568771-6877135.04435.32
670233-7023335.78936.07
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