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%
116.499743497608973359746797443974570.11
216.519778197885978330.08
单位质量响应值RSD%判断
5910.075925.680.19数据可信
供试品溶液-3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%
5min117976-1797618.18919.033.4218.1919.033.43
219512-1951219.74319.74
319397-1939719.62719.63
418108-1810818.32318.32
518826-1882619.04919.05
619015-1901519.24019.24
10min130957-3095731.32432.923.6431.4233.033.64
231970-3197032.34932.46
333975-3397534.37834.49
431879-3187932.25732.36
532605-3260532.99133.10
633836-3383634.23734.34
15min140287-4028740.76441.942.3241.0442.232.33
241011-4101141.49741.79
342997-4299743.50743.81
440826-4082641.31041.59
541961-4196142.45842.75
641625-4162542.11842.42
20min13071-30713.10740.5645.353.6141.0844.80
246339-4633946.88847.41
349572-4957250.16050.70
446015-4601546.56047.07
547855-4785548.42248.95
647671-4767148.23648.77
30min154242-5424254.88556.171.5655.4056.911.70
255549-5554956.20756.99
356715-5671557.38758.21
455230-5523055.88556.65
556179-5617956.84557.64
655136-5513655.78956.59
45min162313-6231363.05263.581.1063.8864.641.18
261836-6183662.56963.66
363473-6347364.22565.36
462674-6267463.41764.50
563618-6361864.37265.48
663069-6306963.81664.93
60min168444-6844469.25569.610.8370.4371.030.88
268376-6837669.18670.63
368540-6854069.35270.85
468768-6876869.58371.01
569906-6990670.73472.20
668762-6876269.57771.04
90min173042-7304273.90874.591.3775.4776.391.40
272183-7218373.03874.86
373749-7374974.62376.50
474193-7419375.07276.89
575096-7509675.98677.85
674031-7403174.90876.76
120min176249-7624977.15378.461.3879.1280.671.46
276653-7665377.56179.79
378208-7820879.13581.43
477030-7703077.94380.18
579040-7904079.97782.26
678073-7807378.99881.26
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179455-7945580.39781.791.5582.7984.441.61
279180-7918080.11882.78
381625-8162582.59285.33
481531-8153182.49785.17
582276-8227683.25185.98
680927-8092781.88684.59
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%
116.499795398451983649821798368982710.20
216.519822498159981920.05
单位质量响应值RSD%判断
5959.435947.430.15数据可信
供试品溶液-4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%
5min13079-30793.09715.3140.363.1015.3140.35
218669-1866918.77718.78
318390-1839018.49718.50
418174-1817418.28018.28
518415-1841518.52218.52
614603-1460314.68814.69
10min130298-3029830.47431.451.8830.4931.531.96
231468-3146831.65131.76
331053-3105331.23331.34
431111-3111131.29231.39
531961-3196132.14732.25
631704-3170431.88831.97
15min139535-3953539.76540.851.8139.9541.111.86
241273-4127341.51341.79
340223-4022340.45740.73
440267-4026740.50140.78
541444-4144441.68541.97
640955-4095541.19341.45
20min146199-4619946.46746.611.2446.8747.101.23
245920-4592046.18746.70
347315-4731547.59048.09
446407-4640746.67747.18
545663-4566345.92846.44
646530-4653046.80047.29
30min153588-5358853.89954.222.1054.5654.962.09
255008-5500855.32756.09
355213-5521355.53456.30
454211-5421154.52655.29
553152-5315253.46154.23
652266-5226652.57053.32
45min162044-6204462.40462.551.1363.3763.601.11
262048-6204862.40863.48
362158-6215862.51963.59
461054-6105461.40962.47
563025-6302563.39164.46
662822-6282263.18764.23
60min168102-6810268.49867.291.1569.8168.681.09
266835-6683567.22368.64
366667-6666767.05468.48
466702-6670267.08968.49
567308-6730867.69969.12
665799-6579966.18167.57
90min170313-7031370.72171.731.2772.4173.501.27
272074-7207472.49374.29
372379-7237972.79974.59
470181-7018170.58972.37
571418-7141871.83373.63
671516-7151671.93173.69
120min175849-7584976.29077.341.4578.3779.501.44
278196-7819678.65080.85
377616-7761678.06780.27
475539-7553975.97878.15
576382-7638276.82679.02
677749-7774978.20180.36
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12403-24032.41767.2947.264.9369.8845.56
281324-8132481.79684.43
380055-8005580.52083.15
478754-7875479.21181.80
580184-8018480.65083.27
678668-7866879.12581.72
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