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%
115.111782361784811780041781241790521783790.24
215.111771681774511773100.12
单位质量响应值RSD%判断
11805.3611734.610.43数据可信
供试品溶液-2025081221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%
15min116577-165778.4078.534.458.418.544.44
216706-167068.4728.47
317304-173048.7758.78
418048-180489.1539.15
515913-159138.0708.07
616423-164238.3298.33
30min132324-3232416.39216.602.5016.4116.622.51
232427-3242716.44516.46
332768-3276816.61716.63
434352-3435217.42117.44
532392-3239216.42716.44
632149-3214916.30416.32
45min144299-4429922.46522.742.3822.5122.782.38
244668-4466822.65222.69
344994-4499422.81822.86
446671-4667123.66823.71
543437-4343722.02822.07
644977-4497722.80922.85
60min155404-5540428.09728.192.3428.1828.272.34
254672-5467227.72627.80
356381-5638128.59228.67
457763-5776329.29329.38
554182-5418227.47727.55
655158-5515827.97228.05
75min164838-6483832.88132.721.8633.0132.851.86
263519-6351932.21232.34
364085-6408532.49932.63
466369-6636933.65733.79
563098-6309831.99932.12
665204-6520433.06733.19
90min175172-7517238.12237.251.8738.3037.431.87
272092-7209236.56036.74
372668-7266836.85237.03
475065-7506538.06738.26
572305-7230536.66836.84
673407-7340737.22737.41
105min179447-7944740.29040.882.9440.5341.122.93
279822-7982240.48040.72
380133-8013340.63740.88
485030-8503043.12143.37
578152-7815239.63339.87
681091-8109141.12341.37
120min187078-8707844.15944.552.2744.4744.862.27
286583-8658343.90844.22
389808-8980845.54445.86
490431-9043145.86046.18
585182-8518243.19843.50
687984-8798444.61944.93
极限192231-9223146.77347.051.8247.1647.441.82
292209-9220946.76147.14
392678-9267846.99947.39
495929-9592948.64849.05
590872-9087246.08346.46
692742-9274247.03247.42
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%
115.111778301780961776021780271776951778500.12
215.111799931797461798700.10
单位质量响应值RSD%判断
11770.3511904.040.80数据可信
供试品溶液-2025081321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%
15min117574-175748.8628.433.768.868.433.74
216961-169618.5538.55
316609-166098.3758.38
415804-158047.9697.97
517061-170618.6038.60
616262-162628.2008.20
30min133672-3367216.97916.754.6516.9916.764.65
233194-3319416.73816.75
335909-3590918.10718.12
431305-3130515.78615.80
532637-3263716.45716.47
632542-3254216.41016.42
45min146028-4602823.21022.962.5823.2523.002.58
246959-4695923.67923.72
345467-4546722.92722.97
443517-4351721.94421.98
546129-4612923.26123.30
645098-4509822.74122.78
60min157316-5731628.90228.431.9828.9828.511.99
257560-5756029.02529.11
356316-5631628.39828.48
454394-5439427.42927.50
556414-5641428.44728.53
656273-5627328.37628.45
75min166560-6656033.56333.262.5633.6933.382.56
268147-6814734.36434.49
366913-6691333.74133.87
463227-6322731.88332.00
565673-6567333.11633.24
665218-6521832.88733.01
90min174916-7491637.77737.232.8137.9637.412.81
277179-7717938.91839.11
372828-7282836.72436.91
471031-7103135.81835.99
573478-7347837.05237.23
673549-7354937.08837.27
105min184804-8480442.76341.632.1743.0141.882.16
283694-8369442.20342.46
380944-8094440.81741.06
480337-8033740.51140.75
583777-8377742.24542.49
681798-8179841.24741.49
120min189984-8998445.37544.841.8245.7045.161.82
290610-9061045.69146.01
388704-8870444.73045.04
485960-8596043.34643.65
589396-8939645.07945.39
688934-8893444.84645.16
极限194381-9438147.59247.421.8747.9947.811.87
296770-9677048.79749.20
393142-9314246.96847.36
491507-9150746.14346.52
593730-9373047.26447.65
694682-9468247.74448.13
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%
115.111799691798681793931791361797541796240.20
215.111783261782861783060.02
单位质量响应值RSD%判断
11887.7611800.530.53数据可信
供试品溶液-2025081321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%
15min117472-174728.8058.653.618.818.653.62
217807-178078.9748.97
317100-171008.6188.62
417711-177118.9258.93
516216-162168.1728.17
616705-167058.4198.42
30min134267-3426717.26917.002.5317.2817.012.53
234956-3495617.61617.63
333238-3323816.75016.76
432947-3294716.60416.62
534164-3416417.21717.23
632834-3283416.54716.56
45min147212-4721223.79323.503.3423.8423.543.34
249458-4945824.92424.97
346456-4645623.41223.45
445566-4556622.96323.01
545825-4582523.09423.14
645240-4524022.79922.84
60min157377-5737728.91528.993.8529.0029.073.83
261926-6192631.20831.29
356803-5680328.62628.71
455991-5599128.21728.30
556687-5668728.56828.65
656327-5632728.38628.47
75min166727-6672733.62733.391.9533.7633.521.96
268269-6826934.40434.54
366526-6652633.52633.65
465012-6501232.76332.89
566327-6632733.42633.55
664692-6469232.60232.73
90min175842-7584238.22137.902.6138.4138.092.61
276707-7670738.65738.85
374110-7411037.34837.53
472667-7266736.62136.80
577938-7793839.27739.46
674002-7400237.29337.47
105min183976-8397642.32041.911.2842.5742.161.28
284902-8490242.78743.05
382764-8276441.70941.96
482146-8214641.39841.64
582705-8270541.67941.93
682460-8246041.55641.80
120min190564-9056445.64045.331.2345.9645.651.24
291766-9176646.24646.58
389883-8988345.29745.61
488552-8855244.62644.94
589529-8952945.11845.44
689398-8939845.05245.36
极限196106-9610648.43347.691.6448.8348.091.63
295849-9584948.30348.71
394928-9492847.83948.23
491815-9181546.27046.66
594906-9490647.82848.22
694214-9421447.47947.87
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