他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.345173665171175172295175545162375171010.10
212.375175575173375174470.04
单位质量响应值RSD%判断
41904.4641830.800.13数据可信
供试品溶液-2025091821批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114754-147542.8172.3544.182.822.3544.11
218642-186423.5603.56
35057-50570.9660.97
414539-145392.7762.78
56123-61231.1691.17
614753-147532.8172.82
10min148781-487819.3146.5038.419.316.4938.41
218424-184243.5183.52
336676-366767.0037.00
444960-449608.5858.58
537258-372587.1147.11
618037-180373.4443.44
15min161825-6182511.8059.7219.5511.819.7219.58
241333-413337.8927.89
353274-5327410.17210.17
459108-5910811.28611.29
553277-5327710.17310.17
636569-365696.9836.98
20min171752-7175213.70111.9912.3413.7011.9912.34
255323-5532310.56410.56
364807-6480712.37512.37
469700-6970013.30913.31
562975-6297512.02512.02
652198-521989.9679.97
30min181204-8120415.50514.249.0115.5114.249.03
267113-6711312.81512.81
377587-7758714.81514.81
480386-8038615.34915.35
575753-7575314.46514.46
665520-6552012.51112.51
45min187096-8709616.63116.056.4216.6316.056.42
276521-7652114.61114.61
387677-8767716.74116.74
489289-8928917.04917.05
585621-8562116.34916.35
678042-7804214.90214.90
极限197171-9717118.55417.853.9718.5517.853.97
289507-8950717.09117.09
395780-9578018.28918.29
495947-9594718.32118.32
594210-9421017.98917.99
688250-8825016.85116.85
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.345145245150335151135158515154625151970.10
212.375148705155095151900.09
单位质量响应值RSD%判断
41750.1641648.340.18数据可信
供试品溶液-2025091921批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125257-252574.8423.4826.044.843.4825.99
212182-121822.3352.34
317068-170683.2723.27
421761-217614.1724.17
517943-179433.4403.44
614773-147732.8322.83
10min149030-490309.4007.4620.419.407.4620.42
237169-371697.1267.13
327036-270365.1835.18
445692-456928.7608.76
534330-343306.5826.58
640310-403107.7287.73
15min161327-6132711.75710.4212.0311.7610.4212.03
252616-5261610.08710.09
344057-440578.4468.45
461429-6142911.77711.78
551974-519749.9649.96
654784-5478410.50310.50
20min170285-7028513.47512.457.6913.4712.457.68
262734-6273412.02712.03
357132-5713210.95310.95
470268-7026813.47113.47
563774-6377412.22612.23
665519-6551912.56112.56
30min181643-8164315.65214.865.1415.6514.865.12
277385-7738514.83614.84
370979-7097913.60813.61
481289-8128915.58415.58
575407-7540714.45714.46
678351-7835115.02115.02
45min190171-9017117.28716.783.1017.2916.783.10
287737-8773716.82116.82
382831-8283115.88015.88
489637-8963717.18517.18
586107-8610716.50816.51
688622-8862216.99016.99
极限197660-9766018.72318.312.3018.7218.312.31
296187-9618718.44118.44
392605-9260517.75417.75
496553-9655318.51118.51
592896-9289617.81017.81
697151-9715118.62518.63
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.345207745193655199325213595204015203660.15
212.375191185177835184500.19
单位质量响应值RSD%判断
42169.0441911.880.44数据可信
供试品溶液-2025092021批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min120582-205823.9143.6827.783.913.6827.77
220185-201853.8383.84
322672-226724.3114.31
420857-208573.9663.97
58666-86661.6481.65
623227-232274.4174.42
10min145478-454788.6487.9614.018.657.9614.03
230788-307885.8555.85
342998-429988.1778.18
447452-474529.0249.02
540893-408937.7767.78
643522-435228.2768.28
15min159368-5936811.29010.4211.1511.2910.4211.15
243171-431718.2098.21
355912-5591210.63210.63
459698-5969811.35211.35
553836-5383610.23810.24
656891-5689110.81810.82
20min169146-6914613.14912.407.1613.1512.407.15
256153-5615310.67810.68
365812-6581212.51512.51
468380-6838013.00313.00
565832-6583212.51912.52
665802-6580212.51312.51
30min180821-8082115.36914.625.5915.3714.625.60
268595-6859513.04413.04
377679-7767914.77214.77
479400-7940015.09915.10
577035-7703514.64914.65
677798-7779814.79414.79
45min189781-8978117.07316.503.4317.0716.503.43
281100-8110015.42215.42
387615-8761516.66116.66
488241-8824116.78016.78
586734-8673416.49316.49
687048-8704816.55316.55
极限198747-9874718.77818.252.5218.7818.252.53
291504-9150417.40117.40
395981-9598118.25218.25
497078-9707818.46018.46
596058-9605818.26718.27
696509-9650918.35218.35
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