玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.169790798253980389863698411982490.30
211.179805198106980780.04
单位质量响应值RSD%判断
8803.678780.480.19数据可信
供试品溶液-02批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123872-2387224.38021.209.9124.3821.209.91
219287-1928719.69819.70
319600-1960020.01720.02
420576-2057621.01421.01
522581-2258123.06223.06
618618-1861819.01419.01
10min142207-4220743.10640.513.7743.3840.753.81
238990-3899039.82040.04
338485-3848539.30539.53
439795-3979540.64240.88
540374-4037441.23441.49
638141-3814138.95339.16
15min152053-5205353.16251.182.9253.9151.872.95
249681-4968150.73951.40
349168-4916850.21550.87
450646-5064651.72552.41
551154-5115452.24352.96
648003-4800349.02549.67
20min156200-5620057.39755.443.1258.7456.693.14
252091-5209153.20054.43
354753-5475355.91957.14
455234-5523456.41057.67
555127-5512756.30157.60
652282-5228253.39554.58
30min163283-6328364.63164.271.9366.6166.141.94
262138-6213863.46165.28
361543-6154362.85464.69
464444-6444465.81667.70
564155-6415565.52167.44
662014-6201463.33565.12
45min171392-7139272.91271.891.7575.6174.481.75
270163-7016371.65774.18
368044-6804469.49372.03
471064-7106472.57775.20
571055-7105572.56875.22
670632-7063272.13674.62
60min172880-7288074.43275.161.3477.9478.541.30
272259-7225973.79877.12
374600-7460076.18979.50
474569-7456976.15779.58
574172-7417275.75279.21
673075-7307574.63177.92
90min177395-7739579.04378.861.1683.3883.081.12
276782-7678278.41782.55
378474-7847480.14584.30
478000-7800079.66183.93
576367-7636777.99382.29
676302-7630277.92782.04
极限181887-8188783.63181.751.4688.8486.841.40
280300-8030082.01087.02
378544-7854480.21785.26
479800-7980081.49986.66
579186-7918680.87286.04
680539-8053982.25487.24
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.169848398675985309864098465985590.10
211.179829298056981740.17
单位质量响应值RSD%判断
8831.458789.080.35数据可信
供试品溶液-02批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19464-94649.64618.1227.429.6518.1227.40
220453-2045320.84620.85
319512-1951219.88619.89
417061-1706117.38817.39
523847-2384724.30524.30
616330-1633016.64316.64
10min132827-3282733.45737.067.6433.5637.267.75
238665-3866539.40739.64
337425-3742538.14338.36
435633-3563336.31736.51
539881-3988140.64640.92
633771-3377134.41934.60
15min145853-4585346.73347.833.3147.2148.443.42
248254-4825449.18049.85
347156-4715648.06148.71
445955-4595546.83747.43
549173-4917350.11750.84
645184-4518446.05146.62
20min155743-5574356.81354.832.0257.8155.971.90
252950-5295053.96655.18
353822-5382254.85556.03
452663-5266353.67454.79
554023-5402355.06056.34
653562-5356254.59055.67
30min163037-6303764.24761.971.9465.8863.731.81
259865-5986561.01462.83
360614-6061461.77763.57
459796-5979660.94462.66
560746-6074661.91263.80
660774-6077461.94063.63
45min170855-7085572.21568.212.9874.5670.652.83
266385-6638567.65970.15
365961-6596167.22769.70
465924-6592467.18969.58
566942-6694268.22770.80
665476-6547666.73369.11
60min173609-7360975.02272.322.2678.1775.522.11
271468-7146872.84076.08
369796-6979671.13674.36
470008-7000871.35274.49
569258-6925870.58773.92
671584-7158472.95876.07
90min177454-7745478.94176.141.9582.9280.141.82
274736-7473676.17080.22
373687-7368775.10179.11
474373-7437375.80079.73
573350-7335074.75878.88
674638-7463876.07080.00
极限183741-8374185.34878.954.3290.2083.804.04
274602-7460276.03480.93
376730-7673078.20383.05
476854-7685478.32983.10
574810-7481076.24681.20
678058-7805879.55684.33
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.169798998509982969823798308982680.19
211.179849098742986160.19
单位质量响应值RSD%判断
8805.388828.650.19数据可信
供试品溶液-02批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121558-2155821.95521.489.7521.9521.489.74
217715-1771518.04118.04
323059-2305923.48323.48
422707-2270723.12523.12
521922-2192222.32622.33
619569-1956919.92919.93
10min137503-3750338.19339.413.5138.4439.653.54
237419-3741938.10838.31
340446-4044641.19141.45
440151-4015140.89041.15
538917-3891739.63339.88
637732-3773238.42738.65
15min147040-4704047.90647.931.9848.5748.602.03
245807-4580746.65047.27
348067-4806748.95249.67
447653-4765348.53049.24
547722-4772248.60049.29
646081-4608146.92947.58
20min152250-5225053.21254.172.1754.4155.382.20
252556-5255653.52354.67
354499-5449955.50256.76
454593-5459355.59856.85
553318-5331854.29955.53
651906-5190652.86154.03
30min160197-6019761.30561.581.4363.1063.391.42
260540-6054061.65463.39
359508-5950860.60362.48
461675-6167562.81064.68
561244-6124462.37164.20
659657-5965760.75562.51
45min166800-6680068.03067.291.1170.5069.791.10
266327-6632767.54869.97
366564-6656467.78970.34
466302-6630267.52270.09
565668-6566866.87769.40
664800-6480065.99368.43
60min170143-7014371.43470.741.9274.6673.991.88
267484-6748468.72671.90
370880-7088072.18575.49
470340-7034071.63574.95
568203-6820369.45872.73
669744-6974471.02874.19
90min175676-7567677.06975.831.7981.0979.861.76
273678-7367875.03478.97
376095-7609577.49681.60
474112-7411275.47679.59
574705-7470576.08080.12
672478-7247873.81277.77
极限176900-7690078.31677.453.7183.1982.323.55
271090-7109072.39977.17
374939-7493976.31881.29
479030-7903080.48585.44
578123-7812379.56184.45
676234-7623477.63782.41
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