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%
116.559785097239975849735797244974550.27
216.529710397394972480.22
单位质量响应值RSD%判断
5888.525886.680.03数据可信
供试品溶液-2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%
5min121689-2168922.05921.153.1322.0621.153.14
220765-2076521.11921.12
319836-1983620.17420.17
421165-2116521.52621.53
520334-2033420.68120.68
621003-2100321.36121.36
10min137590-3759038.23137.972.6638.3538.092.66
237732-3773238.37538.49
336253-3625336.87136.98
438199-3819938.85038.97
535965-3596536.57836.69
638283-3828338.93639.05
15min144675-4467545.43745.342.2945.7745.672.29
244589-4458945.34945.68
342699-4269943.42743.74
445778-4577846.55946.89
545002-4500245.76946.09
644745-4474545.50845.84
20min152102-5210252.99051.901.9553.5852.481.95
251461-5146152.33952.92
349316-4931650.15750.72
451465-5146552.34352.94
550440-5044051.30051.87
651398-5139852.27452.86
30min156639-5663957.60558.081.7358.4958.951.74
257312-5731258.28959.16
355490-5549056.43657.27
458203-5820359.19660.08
556994-5699457.96658.82
657994-5799458.98359.86
45min162776-6277663.84664.192.1265.0565.382.11
263442-6344264.52465.72
361816-6181662.87064.02
464051-6405165.14366.36
561553-6155362.60363.78
665039-6503966.14867.35
60min167289-6728968.43667.992.0469.9969.532.03
267091-6709168.23569.79
365811-6581166.93368.43
468063-6806369.22470.80
564673-6467365.77667.30
668148-6814869.31070.88
90min171359-7135972.57673.091.7774.5175.021.77
272672-7267273.91175.85
370429-7042971.63073.50
473720-7372074.97776.94
570677-7067771.88273.77
672343-7234373.57775.54
120min174893-7489376.17076.221.9278.5178.551.91
275395-7539576.68179.03
373535-7353574.78977.06
477255-7725578.57280.95
573320-7332074.57076.86
675258-7525876.54178.91
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174400-7440075.66977.332.0578.4380.082.03
277352-7735278.67181.44
374066-7406675.32978.01
477625-7762578.94981.76
575655-7565576.94579.65
677113-7711378.42881.22
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%
116.559841798209982069824498279982710.09
216.529970499664996840.03
单位质量响应值RSD%判断
5937.826034.141.14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%
5min16985-69856.9886.804.156.996.804.13
27049-70497.0527.05
36327-63276.3306.33
46882-68826.8856.88
56573-65736.5766.58
66936-69366.9396.94
10min113131-1313113.13613.183.3713.1813.223.37
213105-1310513.11013.15
313013-1301313.01813.05
412477-1247712.48212.52
513564-1356413.56913.61
613731-1373113.73713.78
15min116204-1620416.21116.161.9216.3216.271.90
216423-1642316.43016.54
316397-1639716.40416.51
415572-1557215.57815.69
516136-1613616.14216.25
616210-1621016.21716.33
20min118743-1874318.75119.413.1318.9519.613.13
219468-1946819.47619.68
319540-1954019.54819.75
418743-1874318.75118.94
519552-1955219.56019.76
620362-2036220.37020.58
30min122902-2290222.91122.832.5023.2223.142.49
222704-2270422.71323.02
322261-2226122.27022.58
422144-2214422.15322.45
523468-2346823.47723.79
623466-2346623.47523.79
45min125880-2588025.89026.912.9026.3227.352.88
227267-2726727.27827.72
326678-2667826.68927.12
426208-2620826.21926.64
527905-2790527.91628.36
627457-2745727.46827.92
60min129158-2915829.17030.342.6629.7530.932.64
230334-3033430.34630.94
329825-2982529.83730.42
430262-3026230.27430.84
530967-3096730.97931.58
631426-3142631.43932.04
90min133814-3381433.82834.752.5134.5735.512.51
234653-3465334.66735.42
334362-3436234.37635.12
434030-3403034.04434.78
535570-3557035.58436.35
636006-3600636.02036.80
120min137304-3730437.31938.322.5838.2539.272.56
238058-3805838.07339.02
337627-3762737.64238.58
438036-3803638.05138.98
538755-3875538.77139.74
640055-4005540.07141.05
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137940-3794037.95539.993.8639.0941.153.82
240577-4057740.59341.76
339393-3939339.40940.55
438834-3883438.85039.99
540936-4093640.95242.13
642172-4217242.18943.39
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%
116.559898399234989269882498386988710.32
216.529971699632996740.06
单位质量响应值RSD%判断
5974.086033.540.71数据可信
供试品溶液-2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%
5min120224-2022420.17120.672.5520.1720.672.56
220403-2040320.35020.35
320205-2020520.15220.15
421492-2149221.43621.44
520939-2093920.88420.88
621092-2109221.03721.04
10min135888-3588835.79437.172.1035.9137.292.09
236888-3688836.79236.90
338072-3807237.97338.08
437484-3748437.38637.51
537703-3770337.60537.72
637594-3759437.49637.61
15min144831-4483144.71444.781.5145.0245.101.50
244967-4496744.85045.17
344549-4454944.43344.76
444742-4474244.62544.95
544147-4414744.03244.36
646145-4614546.02546.35
20min151366-5136651.23250.581.5651.7951.151.54
249380-4938049.25149.82
351110-5111050.97751.55
451044-5104450.91151.49
551264-5126451.13051.70
650121-5012149.99050.57
30min157215-5721557.06657.640.9457.9158.500.93
257657-5765757.50758.35
358344-5834458.19259.04
458363-5836358.21159.07
558038-5803857.88758.74
657155-5715557.00657.86
45min162942-6294262.77862.891.5463.9464.071.52
261529-6152961.36962.53
363916-6391663.74964.93
463965-6396563.79864.98
562384-6238462.22163.40
663616-6361663.45064.63
60min167759-6775967.58268.401.8569.0969.921.82
268428-6842868.25069.75
369555-6955569.37470.90
468610-6861068.43169.97
566795-6679566.62168.14
670356-7035670.17271.70
90min170257-7025770.07471.371.9071.9673.271.87
270419-7041970.23572.12
372525-7252572.33674.25
470631-7063170.44772.36
571843-7184371.65673.55
673643-7364373.45175.37
120min175788-7578875.59075.511.0377.8677.801.00
275241-7524175.04577.31
376762-7676276.56278.88
474549-7454974.35576.66
576256-7625676.05778.35
675620-7562075.42377.75
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173195-7319573.00472.993.2175.7075.703.11
271815-7181571.62874.31
376129-7612975.93078.67
475343-7534375.14677.87
569685-6968569.50372.21
672919-7291972.72975.47
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