多替诺雷非布司他片项目信息
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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
19.792998129891301033009130003300140.29
29.853053730658305980.28
单位质量响应值RSD%判断
3065.783106.400.94数据可信
供试品溶液-J057M批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110439-1043930.35030.073.2730.3530.073.27
29884-988428.73728.74
310508-1050830.55130.55
49951-995128.93228.93
510651-1065130.96730.97
610613-1061330.85630.86
10min118479-1847953.72653.592.0353.7853.642.03
217840-1784051.86851.92
318722-1872254.43254.48
418151-1815152.77252.82
518830-1883054.74654.80
618576-1857654.00854.06
15min122774-2277466.21366.882.1766.3567.022.17
222300-2230064.83564.97
323719-2371968.96169.10
422863-2286366.47266.61
523398-2339868.02768.17
622960-2296066.75466.90
20min125495-2549574.12474.902.2074.3775.152.20
225009-2500972.71172.95
326510-2651077.07577.33
425506-2550674.15674.40
526335-2633576.56676.82
625714-2571474.76175.01
30min128928-2892884.10584.731.7884.4885.101.78
228336-2833682.38482.75
329897-2989786.92287.31
429271-2927185.10285.47
529358-2935885.35585.74
629064-2906484.50184.88
45min131331-3133191.09292.232.0391.6192.752.03
230909-3090989.86590.37
332727-3272795.15095.68
431454-3145491.44991.96
532118-3211893.38093.91
631799-3179992.45292.97
60min132696-3269695.06095.951.9195.7396.621.91
232293-3229393.88994.54
334032-3403298.94599.63
432578-3257894.71795.38
533369-3336997.01797.70
633049-3304996.08796.76
90min133754-3375498.13698.391.4598.9699.221.46
233527-3352797.47698.28
334686-34686100.846101.70
433236-3323696.63097.45
533937-3393798.66899.51
633905-3390598.57599.41
极限134091-3409199.11699.001.31100.10100.001.31
233717-3371798.02999.00
334758-34758101.055102.08
433467-3346797.30298.29
534218-3421899.485100.49
634065-3406599.041100.04
多替诺雷非布司他片项目信息
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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
19.793067430534306253070230590306250.22
29.853056930524305460.11
单位质量响应值RSD%判断
3128.193101.120.62数据可信
供试品溶液-J057M批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110629-1062930.61929.725.3330.6229.725.33
210794-1079431.09431.09
39359-935926.96026.96
410605-1060530.54930.55
510552-1055230.39730.40
69960-996028.69128.69
10min117476-1747650.34250.993.3050.3951.043.30
218350-1835052.86052.91
316778-1677848.33248.38
418302-1830252.72252.77
517706-1770651.00551.06
617588-1758850.66550.71
15min121504-2150461.94663.102.6862.0863.232.68
222554-2255464.97065.11
321526-2152662.00962.13
422643-2264365.22765.37
521957-2195763.25163.39
621241-2124161.18861.32
20min124114-2411469.46471.382.4369.7071.622.43
225474-2547473.38273.63
324653-2465371.01771.25
425541-2554173.57573.82
524631-2463170.95471.19
624268-2426869.90870.14
30min127074-2707477.99180.432.3478.3580.802.34
228443-2844381.93582.31
327992-2799280.63680.98
428756-2875682.83683.21
527997-2799780.65081.01
627270-2727078.55678.91
45min129960-2996086.30587.621.9786.7988.111.97
230760-3076088.60989.12
330677-3067788.37088.85
431257-3125790.04190.55
530228-3022887.07787.57
629613-2961385.30585.79
60min130803-3080388.73390.522.0689.3691.162.06
231678-3167891.25491.91
331474-3147490.66691.29
432555-3255593.78094.44
531070-3107089.50290.14
630956-3095689.17489.80
90min132342-3234293.16693.522.0593.9494.312.05
232604-3260493.92194.73
332402-3240293.33994.12
433663-3366396.97297.79
532062-3206292.36093.15
631709-3170991.34392.12
极限133093-3309395.33096.391.5596.2697.341.55
233620-3362096.84897.81
333652-3365296.94097.88
434332-3433298.89999.88
532934-3293494.87295.81
633145-3314595.48096.40
多替诺雷非布司他片项目信息
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D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
19.793001229762299432963029978298650.55
29.853041030638305240.53
单位质量响应值RSD%判断
3050.563098.881.12数据可信
供试品溶液-25111401批-多替诺雷-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16963-696320.31919.937.3120.3219.937.31
26112-611217.83617.84
37641-764122.29822.30
46735-673519.65419.65
56631-663119.35119.35
66901-690120.13820.14
10min117228-1722850.27547.295.0150.3147.325.02
215411-1541144.97245.00
317133-1713349.99850.03
415750-1575045.96245.99
516245-1624547.40647.44
615465-1546545.13045.16
15min121917-2191763.95862.741.6664.0862.851.67
221078-2107861.51061.61
321951-2195164.05764.18
421275-2127562.08562.19
521379-2137962.38862.50
621392-2139262.42662.53
20min124621-2462171.84970.541.2572.0770.761.25
224107-2410770.34970.56
324354-2435471.07071.30
423718-2371869.21469.43
524129-2412970.41370.63
624115-2411570.37270.59
30min127343-2734379.79279.031.1480.1479.361.14
226932-2693278.59378.92
327292-2729279.64479.99
426601-2660177.62777.96
526940-2694078.61678.95
627375-2737579.88680.22
45min129353-2935385.65885.041.1986.1385.511.19
228829-2882984.12984.58
329276-2927685.43385.91
428627-2862783.53984.00
529224-2922485.28185.75
629541-2954186.20786.67
60min130073-3007387.75988.141.2088.3888.751.20
230075-3007587.76588.36
330365-3036588.61189.23
429760-2976086.84687.44
530122-3012287.90288.51
630829-3082989.96590.57
90min131452-3145291.78392.071.2092.5592.821.19
231433-3143391.72892.47
331702-3170292.51393.28
430995-3099590.45091.19
531576-3157692.14592.90
632144-3214493.80394.56
极限131839-3183992.91393.031.1593.8393.941.15
231818-3181892.85193.75
332075-3207593.60194.52
431231-3123191.13892.03
532003-3200393.39194.30
632315-3231594.30295.21
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