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%
116.60 9854298654987589863698747986670.09
216.569978099963998720.13
单位质量响应值RSD%判断
5943.806030.921.03数据可信
供试品溶液-24073001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%
5min112338-1233812.34012.722.6112.3412.722.63
213024-1302413.02613.03
312252-1225212.25412.25
412883-1288312.88512.89
512905-1290512.90712.91
612893-1289312.89512.90
10min125961-2596125.96525.052.1926.0325.122.17
225238-2523825.24225.31
324573-2457324.57724.65
424419-2441924.42324.49
525043-2504325.04725.12
625019-2501925.02325.09
15min134642-3464234.64834.091.6834.8634.301.67
233838-3383833.84334.06
333928-3392833.93334.14
434509-3450934.51534.72
534469-3446934.47534.69
633133-3313333.13833.35
20min141102-4110241.10940.750.8341.5141.140.82
240494-4049440.50040.90
340672-4067240.67941.07
440263-4026340.26940.67
540795-4079540.80241.20
641110-4111041.11741.51
30min151047-5104751.05550.680.9451.6951.310.93
250432-5043250.44051.07
350399-5039950.40751.03
451455-5145551.46352.09
550519-5051950.52751.16
650206-5020650.21450.84
45min160041-6004160.05160.320.6860.9761.220.66
260084-6008460.09461.00
360670-6067060.68061.58
460537-6053760.54761.46
559745-5974559.75560.66
660763-6076360.77361.67
60min165588-6558865.59966.821.2866.8568.061.25
267429-6742967.44068.68
367738-6773867.74968.99
465992-6599266.00367.25
567302-6730267.31368.55
666812-6681266.82368.06
90min177169-7716977.18176.420.7278.8078.040.71
276651-7665176.66378.28
376674-7667476.68678.30
476137-7613776.14977.76
576251-7625176.26377.88
675575-7557575.58777.20
120min179846-7984679.85979.761.2081.9081.801.17
278326-7832678.33980.38
379791-7979179.80481.84
480429-8042980.44282.48
579077-7907779.09081.13
681025-8102581.03883.07
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184028-8402884.04181.662.7786.5384.152.70
281618-8161881.63184.11
381302-8130281.31583.80
483196-8319683.20985.69
577523-7752377.53580.01
682241-8224182.25484.74
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%
116.60 1007601007381005331004081003061005490.20
216.561006461009961008210.25
单位质量响应值RSD%判断
6057.176088.220.37数据可信
供试品溶液-24073002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%
5min114626-1462614.42214.203.2014.4214.203.20
214283-1428314.08414.08
313575-1357513.38613.39
414571-1457114.36814.37
514414-1441414.21314.21
614934-1493414.72614.73
10min127420-2742027.03826.823.2627.1226.903.25
225680-2568025.32225.40
326654-2665426.28226.36
427799-2779927.41127.49
527602-2760227.21727.30
628060-2806027.66927.75
15min137198-3719836.67936.551.9236.9136.781.93
235823-3582335.32435.54
336642-3664236.13136.35
437552-3755237.02837.26
537607-3760737.08337.31
637568-3756837.04437.28
20min144627-4462744.00543.382.4544.4443.812.44
242085-4208541.49841.91
344499-4449943.87944.30
443339-4333942.73543.17
544837-4483744.21244.65
644570-4457043.94944.39
30min155259-5525954.48952.802.2555.1753.472.25
251633-5163350.91351.56
353377-5337752.63353.30
453656-5365652.90853.58
554218-5421853.46254.14
653135-5313552.39453.08
45min164669-6466963.76761.372.5764.7562.332.56
259759-5975958.92659.85
362933-6293362.05663.01
461950-6195061.08662.06
561847-6184760.98561.96
662257-6225761.38962.37
60min162687-6268761.81366.994.1163.1568.304.03
267060-6706066.12567.38
368976-6897668.01469.32
470098-7009869.12170.43
569931-6993168.95670.27
668895-6889567.93569.25
90min177333-7733376.25575.971.1377.9377.651.14
275653-7565374.59876.22
377650-7765076.56878.25
476701-7670175.63277.32
578146-7814677.05778.76
676807-7680775.73677.43
120min177719-7771976.63679.904.0978.7482.004.00
277247-7724776.17078.21
383908-8390882.73884.84
485476-8547684.28486.40
581718-8171880.57982.71
680100-8010078.98381.10
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182445-8244581.29681.422.3383.8283.962.31
278998-7899877.89780.36
384303-8430383.12885.69
483818-8381882.65085.23
582249-8224981.10283.68
683596-8359682.43184.99
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