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TAAF230001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(%)99.8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%
116.529658096577965399653396499965460.04
216.619674096688967140.04
单位质量响应值RSD%判断
5844.195822.640.27数据可信
供试品溶液-24052002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%
5min129993-2999330.78832.788.0730.7932.788.06
230877-3087731.69531.70
330560-3056031.37031.37
433547-3354734.43634.44
530157-3015730.95630.96
636477-3647737.44437.44
10min145636-4563646.84649.026.4147.0249.216.41
245704-4570446.91547.09
349023-4902350.32250.50
448353-4835349.63549.83
544825-4482546.01346.19
652996-5299654.40154.61
15min153935-5393555.36457.465.3055.8057.925.31
253838-5383855.26555.70
358019-5801959.55760.01
456361-5636157.85558.32
553025-5302554.43054.86
660679-6067962.28762.80
20min159144-5914460.71263.224.7961.4564.004.80
259980-5998061.57062.31
363510-6351065.19365.98
462583-6258364.24265.03
558326-5832659.87260.60
666001-6600167.75068.61
30min164238-6423865.94167.534.5767.0268.664.59
264079-6407965.77766.86
366699-6669968.46769.61
467931-6793169.73170.88
561738-6173863.37464.44
670035-7003571.89173.12
45min171373-7137373.26574.953.8874.7176.453.90
271490-7149073.38574.84
373545-7354575.49477.02
474426-7442676.39977.93
569630-6963071.47572.89
677617-7761779.67481.31
60min174290-7429076.25978.315.5578.1180.225.53
273845-7384575.80277.66
379038-7903881.13383.08
477704-7770479.76381.72
570502-7050272.37174.18
682322-8232284.50486.58
90min174337-7433776.30780.235.7778.5882.585.74
274759-7475976.74079.02
377945-7794580.01182.41
480962-8096283.10885.51
575151-7515177.14379.36
685800-8580088.07490.62
120min176235-7623578.25680.514.4980.9583.314.51
277428-7742879.48082.19
378991-7899181.08583.93
479438-7943881.54384.41
574081-7408176.04478.69
684406-8440686.64389.68
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179322-7932281.42485.013.8684.5688.263.88
282082-8208284.25787.41
384963-8496387.21590.51
481831-8183184.00087.31
580619-8061982.75685.82
688088-8808890.42393.94
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TAAF230001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(%)99.8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%
116.529696697223973459712996980971290.17
216.619928299479993800.15
单位质量响应值RSD%判断
5879.485983.141.24数据可信
供试品溶液-24052003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%
5min112941-1294113.06613.175.9713.0713.175.97
213441-1344113.57013.57
311537-1153711.64811.65
413209-1320913.33613.34
513546-1354613.67713.68
613603-1360313.73413.73
10min124656-2465624.89424.863.5324.9724.933.54
224921-2492125.16125.24
323209-2320923.43323.50
424079-2407924.31124.39
525190-2519025.43325.51
625655-2565525.90225.98
15min132461-3246132.77433.423.0832.9833.633.08
232990-3299033.30833.52
332511-3251132.82433.02
432394-3239432.70632.92
533174-3317433.49433.71
635080-3508035.41835.64
20min140296-4029640.68439.762.3341.0840.162.34
238727-3872739.10039.50
338540-3854038.91139.29
438481-3848138.85239.24
539736-3973640.11940.52
640519-4051940.90941.33
30min145223-4522345.65946.412.6046.2847.032.59
245010-4501045.44446.06
345400-4540045.83746.43
445679-4567946.11946.73
546286-4628646.73247.36
648228-4822848.69349.34
45min154374-5437454.89853.892.2155.7754.772.20
253315-5331553.82954.70
351709-5170952.20753.06
452776-5277653.28454.15
553089-5308953.60054.49
655012-5501255.54256.46
60min160292-6029260.87359.572.7462.0560.752.74
258242-5824258.80359.97
357539-5753958.09359.23
457110-5711057.66058.82
559691-5969160.26661.45
661154-6115461.74362.97
90min166565-6656567.20666.394.1468.7267.904.10
264643-6464365.26666.76
362348-6234862.94964.41
465105-6510565.73267.21
565351-6535165.98167.50
670538-7053871.21872.78
120min169399-6939970.06870.052.6471.9671.922.64
267584-6758468.23570.09
367808-6780868.46170.27
469042-6904269.70771.55
569794-6979470.46672.35
672660-7266073.36075.32
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174583-7458375.30274.121.8477.5876.381.86
273222-7322273.92776.16
371367-7136772.05574.25
472692-7269273.39275.62
573496-7349674.20476.48
675127-7512775.85178.22
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