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%
115.331781731780801768881773681766071774230.40
215.311780681789631785160.36
单位质量响应值RSD%判断
11573.5811660.090.53数据可信
供试品溶液-2025081121批-含40%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%
15min110153-101535.2174.778.785.224.778.76
210106-101065.1935.19
38389-83894.3104.31
49472-94724.8674.87
58262-82624.2454.25
69281-92814.7694.77
30min122273-2227311.44410.429.3711.4510.439.36
219774-1977410.16010.17
319238-192389.8859.89
422900-2290011.76611.77
517955-179559.2269.23
619581-1958110.06110.07
45min131470-3147016.17015.344.5216.2015.374.53
229048-2904814.92514.95
330941-3094115.89815.92
430485-3048515.66415.69
527853-2785314.31114.33
629363-2936315.08715.11
60min139810-3981020.45519.533.3120.5119.583.31
236698-3669818.85618.91
338217-3821719.63619.69
438820-3882019.94620.00
536511-3651118.76018.81
637956-3795619.50219.55
75min147024-4702424.16223.172.5924.2523.262.60
243906-4390622.55922.64
345286-4528623.26923.35
445608-4560823.43423.52
543953-4395322.58422.66
644837-4483723.03823.12
90min153586-5358627.53326.872.7927.6626.992.78
250711-5071126.05626.18
352901-5290127.18127.30
452958-5295827.21127.34
550199-5019925.79325.91
653396-5339627.43627.56
105min159617-5961730.63229.892.4730.8130.062.48
256280-5628028.91729.08
357588-5758829.58929.76
459387-5938730.51430.69
556908-5690829.24029.40
659269-5926930.45330.62
120min164646-6464633.21632.472.1033.4432.682.11
261942-6194231.82732.04
362781-6278132.25832.47
464069-6406932.91933.14
561435-6143531.56631.77
664240-6424033.00733.22
极限169013-6901335.46035.171.6435.7435.441.63
266333-6633334.08334.35
368107-6810734.99435.26
469254-6925435.58435.86
569163-6916335.53735.80
668846-6884635.37435.65
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%
115.331779441780591775041770401770311775160.28
215.311778871770341774600.34
单位质量响应值RSD%判断
11579.6511591.120.08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%
15min113581-135816.9975.3915.867.005.3915.85
210166-101665.2385.24
310853-108535.5915.59
49327-93274.8054.81
59738-97385.0175.02
69062-90624.6694.67
30min119929-1992910.26710.192.9310.2810.202.92
219849-1984910.22610.23
320099-2009910.35510.36
419203-192039.8939.90
519003-190039.7909.80
620558-2055810.59210.60
45min127721-2772114.28214.655.7614.3114.685.76
228717-2871714.79514.82
331640-3164016.30116.33
427458-2745814.14614.17
527553-2755314.19514.22
627553-2755314.19514.22
60min137309-3730919.22218.273.3119.2718.323.31
235444-3544418.26118.31
336325-3632518.71518.77
434134-3413417.58617.63
534625-3462517.83917.89
634959-3495918.01118.06
75min141317-4131721.28721.494.3921.3721.574.38
241784-4178421.52721.61
345239-4523923.30723.39
440109-4010920.66420.74
540607-4060720.92121.00
641162-4116221.20721.29
90min148073-4807324.76724.581.6424.8924.701.64
248987-4898725.23825.35
347923-4792324.69024.81
446853-4685324.13924.25
547221-4722124.32824.44
647196-4719624.31524.43
105min152890-5289027.24927.181.7827.4127.341.77
252636-5263627.11827.28
353000-5300027.30627.47
451618-5161826.59426.75
554332-5433227.99228.15
652054-5205426.81826.97
120min157829-5782929.79429.630.4730.0029.840.47
257499-5749929.62429.83
357345-5734529.54429.75
457531-5753129.64029.84
557114-5711429.42529.63
657779-5777929.76829.97
极限162001-6200131.94331.950.8132.2032.200.82
262430-6243032.16432.42
362615-6261532.25932.52
461799-6179931.83932.08
562030-6203031.95832.21
661206-6120631.53331.78
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