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%
112.341267421264971268151268881267141267310.12
212.371264601268231266420.21
单位质量响应值RSD%判断
10269.9410237.830.23数据可信
供试品溶液-2025091521批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110532-105328.21111.2721.398.2111.2721.40
216356-1635612.75212.75
316753-1675313.06113.06
410417-104178.1228.12
516219-1621912.64512.65
616487-1648712.85412.85
10min128839-2883922.48424.987.5622.4824.987.56
233427-3342726.06126.06
333789-3378926.34426.34
429040-2904022.64122.64
533993-3399326.50326.50
633159-3315925.85225.85
15min137889-3788929.54030.922.9729.5430.922.97
240387-4038731.48831.49
340447-4044731.53431.53
438434-3843429.96529.96
540247-4024731.37831.38
640542-4054231.60831.61
20min143569-4356933.96834.842.1633.9734.842.16
245188-4518835.23135.23
344831-4483134.95234.95
443466-4346633.88833.89
545303-4530335.32035.32
645804-4580435.71135.71
30min150280-5028039.20139.761.1839.2039.761.18
251076-5107639.82139.82
351404-5140440.07740.08
450249-5024939.17739.18
551643-5164340.26340.26
651367-5136740.04840.05
45min157666-5766644.95944.950.2244.9644.950.21
257799-5779945.06345.06
357500-5750044.83044.83
457728-5772845.00845.01
557523-5752344.84844.85
657734-5773445.01245.01
极限165544-6554451.10151.270.6151.1051.270.61
265658-6565851.19051.19
366015-6601551.46851.47
466090-6609051.52751.53
565120-6512050.77150.77
666144-6614451.56951.57
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%
112.341268401273371275031271891266971271130.27
212.371272431264531268480.45
单位质量响应值RSD%判断
10300.8910254.490.32数据可信
供试品溶液-2025091522批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15571-55714.3337.4162.914.337.4162.91
211577-115779.0059.01
3-0.0000.00
49360-93607.2817.28
514400-1440011.20111.20
616243-1624312.63512.63
10min121780-2178016.94121.9718.1916.9421.9718.20
230787-3078723.94723.95
321986-2198617.10217.10
429708-2970823.10823.11
531130-3113024.21424.21
634078-3407826.50726.51
15min133375-3337525.96129.458.1525.9629.458.16
238941-3894130.29030.29
334927-3492727.16827.17
439240-3924030.52330.52
539029-3902930.35830.36
641663-4166332.40732.41
20min139656-3965630.84633.905.6630.8533.905.66
244326-4432634.47934.48
341647-4164732.39532.39
445014-4501435.01435.01
544520-4452034.63034.63
646360-4636036.06136.06
30min146912-4691236.49039.274.2636.4939.274.26
251347-5134739.94039.94
348997-4899738.11238.11
452158-5215840.57140.57
550960-5096039.63939.64
652569-5256940.89040.89
45min154175-5417542.14044.853.3542.1444.853.34
258045-5804545.15045.15
356987-5698744.32744.33
459414-5941446.21546.21
558095-5809545.18945.19
659259-5925946.09446.09
极限164660-6466050.29551.461.4850.3051.461.47
266494-6649451.72251.72
365590-6559051.01951.02
467366-6736652.40052.40
565933-6593351.28651.29
666897-6689752.03552.04
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%
112.341269761262881269601269161270191268320.25
212.371268711267011267860.10
单位质量响应值RSD%判断
10278.1210249.470.20数据可信
供试品溶液-2025091621批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13193-31932.4876.9238.702.496.9238.66
29969-99697.7657.76
39738-97387.5857.58
413036-1303610.15410.15
56747-67475.2555.26
610592-105928.2508.25
10min122565-2256517.57621.7115.8017.5821.7115.79
228986-2898622.57722.58
328246-2824622.00122.00
434655-3465526.99326.99
523479-2347918.28818.29
629295-2929522.81822.82
15min133965-3396526.45528.738.7526.4628.738.76
237571-3757129.26429.26
336266-3626628.24728.25
442440-4244033.05633.06
533514-3351426.10426.10
637560-3756029.25529.26
20min140510-4051031.55333.476.6931.5533.476.70
243796-4379634.11234.11
341867-4186732.61032.61
447840-4784037.26237.26
539983-3998331.14331.14
643815-4381534.12734.13
30min148677-4867737.91439.185.3237.9139.185.31
251775-5177540.32740.33
348212-4821237.55237.55
454839-5483942.71442.71
547872-4787237.28737.29
650413-5041339.26639.27
45min156246-5624643.81044.604.5343.8144.604.53
258897-5889745.87545.87
354757-5475742.65042.65
461515-6151547.91447.91
554905-5490542.76542.77
657208-5720844.55944.56
极限165279-6527950.84551.382.3450.8551.382.33
266383-6638351.70551.71
364767-6476750.44750.45
468739-6873953.54053.54
564541-6454150.27150.27
666083-6608351.47251.47
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