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%
116.509432994354944149437394253943450.07
216.539539595275953350.09
单位质量响应值RSD%判断
5717.885767.390.61数据可信
供试品溶液-24061801-1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%
5min113984-1398414.58215.404.3814.5815.404.39
215870-1587016.54816.55
314697-1469715.32515.33
414293-1429314.90414.90
514871-1487115.50715.51
614906-1490615.54315.54
10min125585-2558526.67927.322.5326.7627.412.53
226809-2680927.95528.05
326063-2606327.17727.26
425291-2529126.37226.45
526646-2664627.78527.87
626822-2682227.96928.05
15min131696-3169633.05133.822.7433.2834.062.74
233485-3348534.91635.16
331718-3171833.07433.31
431527-3152732.87533.10
532901-3290134.30734.55
633293-3329334.71634.96
20min135673-3567337.19838.523.0337.6138.943.02
237299-3729938.89339.33
336279-3627937.83038.25
436227-3622737.77638.19
537389-3738938.98739.42
638772-3877240.42940.86
30min140991-4099142.74342.782.3143.3643.422.31
242025-4202543.82144.48
340169-4016941.88642.52
439705-3970541.40242.02
541982-4198243.77744.42
641291-4129143.05643.72
45min145622-4562247.57248.302.4948.4349.182.48
247479-4747949.50950.41
344596-4459646.50247.37
445816-4581647.77448.63
547047-4704749.05849.95
647344-4734449.36850.27
60min149884-4988452.01652.401.3453.1453.541.34
250538-5053852.69853.87
349568-4956851.68752.81
450461-5046152.61853.74
549681-4968151.80552.97
651351-5135153.54654.72
90min155429-5542957.79858.551.8759.2159.981.87
256924-5692459.35760.83
355170-5517057.52858.94
455378-5537857.74559.15
556165-5616558.56660.02
657818-5781860.28961.76
120min159140-5914061.66862.941.5663.4064.701.53
260657-6065763.25065.05
361159-6115963.77365.50
460689-6068963.28365.01
559245-5924561.77763.55
661280-6128063.89965.70
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163037-6303765.73267.131.0967.8169.241.09
264458-6445867.21369.36
364711-6471167.47769.56
464434-6443467.18869.27
564581-6458167.34269.46
665067-6506767.84870.01
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%
116.509500795024950219499794914949930.05
216.539488494824948540.05
单位质量响应值RSD%判断
5757.155738.290.24数据可信
供试品溶液-24061801-1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%
5min116254-1625416.93417.002.3116.9317.002.32
216814-1681417.51717.52
315707-1570716.36416.36
416150-1615016.82516.83
516522-1652217.21317.21
616447-1644717.13517.13
10min126608-2660827.72028.331.8127.8128.421.81
227752-2775228.91229.01
326578-2657827.68927.78
427558-2755828.71028.80
527337-2733728.48028.58
627308-2730828.45028.54
15min132773-3277334.14334.621.4234.3934.871.42
233946-3394635.36535.62
332728-3272834.09634.34
433168-3316834.55534.81
533198-3319834.58634.84
633586-3358634.99035.24
20min137470-3747039.03639.241.5339.4739.691.53
238058-3805839.64940.10
336739-3673938.27538.71
438160-3816039.75540.20
538196-3819639.79340.24
637385-3738538.94839.40
30min142794-4279444.58345.301.8545.2445.961.84
243665-4366545.49046.17
342790-4279044.57945.23
444927-4492746.80547.47
543590-4359045.41246.08
643101-4310144.90345.57
45min148487-4848750.51450.400.9951.4251.310.99
248250-4825050.26751.19
347553-4755349.54150.44
448982-4898251.03051.96
548616-4861650.64851.57
648355-4835550.37751.29
60min152547-5254754.74455.591.1755.9356.791.17
254030-5403056.28957.50
352683-5268354.88656.06
453921-5392156.17557.38
553388-5338855.62056.82
653608-5360855.84957.04
90min158454-5845460.89861.841.1562.3863.341.14
259179-5917961.65363.17
359289-5928961.76863.24
459380-5938061.86263.38
560569-6056963.10164.61
659302-5930261.78163.28
120min162500-6250065.11365.481.3766.9467.331.35
262273-6227364.87666.74
361686-6168664.26566.08
463211-6321165.85467.72
563428-6342866.08067.94
664035-6403566.71268.56
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168075-6807570.92169.382.1473.1171.592.08
267130-6713069.93672.16
364818-6481867.52869.70
465295-6529568.02570.26
568179-6817971.02973.26
666094-6609468.85771.07
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%
116.509335293370933539335193249933350.06
216.539317492817929960.28
单位质量响应值RSD%判断
5656.675625.890.39数据可信
供试品溶液-24061801-1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%
5min118797-1879719.95219.452.1919.9519.452.19
218617-1861719.76119.76
317854-1785418.95118.95
418437-1843719.57019.57
517824-1782418.92018.92
618435-1843519.56819.57
10min127681-2768129.38328.761.4629.4928.871.45
227219-2721928.89229.00
326863-2686328.51428.62
427058-2705828.72128.83
527229-2722928.90329.01
626507-2650728.13628.25
15min133497-3349735.55635.231.4135.8335.501.40
233647-3364735.71535.99
333667-3366735.73636.00
432967-3296734.99335.26
532737-3273734.74935.02
632640-3264034.64634.91
20min137889-3788940.21839.421.8240.6939.881.81
236943-3694339.21439.68
337464-3746439.76740.23
436120-3612038.34038.80
537717-3771740.03540.49
636701-3670138.95739.41
30min141302-4130243.84143.821.3644.5444.501.33
241277-4127743.81444.50
340747-4074743.25243.93
440613-4061343.10943.79
541667-4166744.22844.91
642102-4210244.69045.36
45min147984-4798450.93450.571.0051.8751.490.99
247711-4771150.64451.57
348129-4812951.08752.01
447778-4777850.71551.63
547423-4742350.33851.26
646800-4680049.67750.60
60min152254-5225455.46654.731.5956.6955.941.57
251310-5131054.46455.68
352521-5252155.74956.96
450762-5076253.88255.08
550521-5052153.62654.83
651973-5197355.16856.37
90min156291-5629159.75160.312.9561.2861.822.88
256994-5699460.49762.01
356764-5676460.25361.77
456084-5608459.53161.03
554902-5490258.27759.78
659895-5989563.57765.08
120min160059-6005963.75163.472.1865.6165.312.13
259570-5957063.23265.08
358834-5883462.45064.30
458484-5848462.07963.91
559623-5962363.28865.12
662181-6218166.00367.86
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163625-6362567.53667.761.2769.7569.961.22
263625-6362567.53669.74
364591-6459168.56170.76
464983-6498368.97771.15
562779-6277966.63868.82
663403-6340367.30069.52
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