托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.591003981003431003211003181002881003340.05
216.641009001022311015660.93
单位质量响应值RSD%判断
6047.866103.730.66数据可信
供试品溶液-24042301批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18694-86948.5868.154.328.598.154.34
28362-83628.2588.26
38294-82948.1918.19
48329-83298.2258.23
57604-76047.5097.51
68244-82448.1418.14
10min117293-1729317.07816.514.0617.1316.564.04
215392-1539215.20015.25
316979-1697916.76816.81
416856-1685616.64616.69
516733-1673316.52516.57
617069-1706916.85616.90
15min123689-2368923.39423.225.2323.5423.365.20
221080-2108020.81720.95
323935-2393523.63723.78
423689-2368923.39423.53
524361-2436124.05824.19
624321-2432124.01824.16
20min129562-2956229.19427.239.0429.4727.508.96
225860-2586025.53825.78
328273-2827327.92128.19
431101-3110130.71430.98
524578-2457824.27224.54
626086-2608625.76126.03
30min136389-3638935.93634.704.5736.3735.124.55
232211-3221131.81032.20
334558-3455834.12834.55
435259-3525934.82035.26
535958-3595835.51035.91
636450-3645035.99636.41
45min143017-4301742.48141.402.4943.1242.012.51
240014-4001439.51640.08
342058-4205841.53442.15
441891-4189141.36942.00
541884-4188441.36241.96
642664-4266442.13342.75
60min146805-4680546.22246.422.8947.0947.262.90
244453-4445343.89944.68
347266-4726646.67747.52
447814-4781447.21948.08
547351-4735146.76147.59
648356-4835647.75448.60
90min153617-5361752.94952.943.4154.0854.043.38
251558-5155850.91651.94
351396-5139650.75651.86
454005-5400553.33254.46
555419-5541954.72955.82
655634-5563454.94156.06
120min160713-6071359.95758.782.7261.3860.172.71
257537-5753756.82058.13
357465-5746556.74958.14
459750-5975059.00660.43
560634-6063459.87961.27
661004-6100460.24461.66
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限164766-6476663.95963.412.1465.7165.132.07
265192-6519264.38066.01
362218-6221861.44363.15
463383-6338362.59464.34
566010-6601065.18866.91
663719-6371962.92564.68
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.591033531035531036591036121033711035100.14
216.641043941051951047940.55
单位质量响应值RSD%判断
6239.306297.720.66数据可信
供试品溶液-24042302批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110150-101509.7159.392.759.729.392.77
210109-101099.6769.68
39698-96989.2839.28
49792-97929.3739.37
59476-94769.0709.07
69630-96309.2189.22
10min119423-1942318.59118.611.3118.6518.671.33
219802-1980218.95419.01
319215-1921518.39218.44
419707-1970718.86318.92
519343-1934318.51518.57
619193-1919318.37118.42
15min127383-2738326.21125.662.1226.3725.822.11
226743-2674325.59825.76
326643-2664325.50225.66
427116-2711625.95526.11
527168-2716826.00526.16
625797-2579724.69324.85
20min132380-3238030.99431.011.0631.3031.301.06
232524-3252431.13231.43
332424-3242431.03631.33
432371-3237130.98531.29
532860-3286031.45331.75
631806-3180630.44430.73
30min139142-3914237.46637.501.1537.9437.971.15
239907-3990738.19838.67
338994-3899437.32537.79
439221-3922137.54238.02
539268-3926837.58738.06
638517-3851736.86837.33
45min147664-4766445.62344.481.8246.3145.161.79
245375-4537543.43244.12
346428-4642844.44045.12
447159-4715945.14045.82
546378-4637844.39245.07
645816-4581643.85444.52
60min152102-5210249.87149.392.8550.8150.322.79
252234-5223449.99850.93
348688-4868846.60347.53
451640-5164049.42950.36
552674-5267450.41951.35
652278-5227850.04050.95
90min155535-5553553.15755.474.3854.3756.674.28
257096-5709654.65255.86
356846-5684654.41255.59
456741-5674154.31255.52
558835-5883556.31657.52
662652-6265259.97061.16
120min162833-6283360.14359.143.4061.6560.643.30
257983-5798355.50157.01
363726-6372660.99862.48
462919-6291960.22561.73
562417-6241759.74561.27
660810-6081058.20659.73
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限167765-6776564.86463.541.5566.7165.371.51
267164-6716464.28866.11
365549-6554962.74364.56
466713-6671363.85765.70
566037-6603763.21065.06
665038-6503862.25364.10
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