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%
116.479714596998970919697496957970330.09
216.489677996896968380.09
单位质量响应值RSD%判断
5891.505876.090.19数据可信
供试品溶液-24112601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%
5min19048-90489.2089.485.079.219.485.06
29009-90099.1699.17
38780-87808.9368.94
410090-1009010.26910.27
59438-94389.6059.61
69527-95279.6969.70
10min124558-2455824.99324.003.3125.0424.053.31
222736-2273623.13923.19
322742-2274223.14523.19
424288-2428824.71824.78
523303-2330323.71623.77
623876-2387624.29924.35
15min136407-3640737.05234.714.1337.2434.904.12
232324-3232432.89733.08
333917-3391734.51834.70
434604-3460435.21735.41
533063-3306333.64933.83
634341-3434134.94935.14
20min143092-4309243.85542.532.7344.2542.912.73
241965-4196542.70843.07
340031-4003140.74041.11
442944-4294443.70544.09
541369-4136942.10242.47
641365-4136542.09842.48
30min149752-4975250.63350.813.0951.2751.423.08
247981-4798148.83149.43
349416-4941650.29150.89
452426-5242653.35553.99
549097-4909749.96750.57
650859-5085951.76052.38
45min161602-6160262.69360.732.7863.6161.632.78
258702-5870259.74260.61
358515-5851559.55160.43
461705-6170562.79863.73
557782-5778258.80559.69
659733-5973360.79161.70
60min166577-6657767.75666.941.7669.0368.171.75
263669-6366964.79766.00
366673-6667367.85469.06
466458-6645867.63568.91
565974-6597467.14368.35
665287-6528766.44367.69
90min170959-7095972.21672.363.0173.8673.962.97
267445-6744568.64070.20
370159-7015971.40272.99
473276-7327674.57476.23
572884-7288474.17575.76
671857-7185773.13074.74
120min175674-7567477.01479.142.3779.0681.142.32
277966-7796679.34781.29
376279-7627977.63079.61
478939-7893980.33782.41
577026-7702678.39080.39
680666-8066682.09584.11
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175020-7502076.34976.742.4378.8279.192.35
274233-7423375.54877.93
377054-7705478.41980.83
473244-7324474.54177.06
574768-7476876.09278.52
678129-7812979.51381.99
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%
116.479697996923969669686796990969450.06
216.489690896972969400.05
单位质量响应值RSD%判断
5886.165882.280.05数据可信
供试品溶液-24112602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%
5min15188-51885.2805.8910.815.285.8910.85
25780-57805.8825.88
36094-60946.2016.20
46080-60806.1876.19
54947-49475.0345.03
66631-66316.7486.75
10min118082-1808218.40119.256.0818.4319.296.08
218460-1846018.78618.82
319036-1903619.37219.41
419275-1927519.61519.65
517716-1771618.02818.06
620948-2094821.31721.35
15min130267-3026730.80131.296.1230.9331.436.13
229230-2923029.74629.88
332200-3220032.76832.91
431668-3166832.22732.37
528093-2809328.58828.72
633019-3301933.60133.76
20min140753-4075341.47239.924.1741.7740.234.17
237930-3793038.59938.90
339743-3974340.44440.77
438981-3898139.66939.99
536876-3687637.52637.81
641090-4109041.81542.16
30min149370-4937050.24150.451.8150.7750.981.81
249953-4995350.83451.35
348345-4834549.19849.75
449308-4930850.17850.72
549400-4940050.27150.77
651066-5106651.96752.54
45min160707-6070761.77861.261.5062.5962.081.50
261303-6130362.38463.18
359577-5957760.62861.45
459594-5959460.64561.47
559073-5907360.11560.89
660950-6095062.02562.89
60min169114-6911470.33368.202.1571.4969.362.12
267499-6749968.68969.84
367452-6745268.64269.80
464754-6475465.89667.05
566376-6637667.54768.66
666934-6693468.11569.32
90min173769-7376975.07073.984.5076.6275.524.40
271389-7138972.64874.18
374907-7490776.22877.77
467000-6700068.18269.71
576330-7633077.67679.16
672810-7281074.09475.68
120min179250-7925080.64879.611.2182.6181.561.18
279540-7954080.94382.87
377425-7742578.79180.75
477411-7741178.77680.68
578165-7816579.54481.46
677613-7761378.98280.98
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180461-8046181.88083.711.8984.2986.101.80
281576-8157683.01585.40
382062-8206283.50985.91
484967-8496786.46688.81
582912-8291284.37486.73
681561-8156183.00085.44
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