多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.313316133145330473284933100330600.39
210.253293032999329640.15
单位质量响应值RSD%判断
3206.603216.000.21数据可信
加速6月-供试品溶液-2025072421批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16465-646518.06316.7910.2818.0616.7910.28
26921-692119.33719.34
35984-598416.71916.72
45156-515614.40514.41
55664-566415.82515.82
65870-587016.40016.40
10min111979-1197933.46831.707.2133.5031.737.21
212079-1207933.74833.78
310902-1090230.45930.49
49918-991827.71027.73
511474-1147432.05732.08
611735-1173532.78732.81
15min115453-1545343.17441.633.8143.2641.713.82
215210-1521042.49642.58
314880-1488041.57441.65
413816-1381638.60138.67
515018-1501841.95942.04
615028-1502841.98742.07
20min117946-1794650.14049.161.2850.3049.311.29
217530-1753048.97749.14
317587-1758749.13749.28
417249-1724948.19248.33
517591-1759149.14849.30
617673-1767349.37749.53
30min120664-2066457.73457.510.6757.9857.740.68
220571-2057157.47457.71
320531-2053157.36257.59
420386-2038656.95757.17
520794-2079458.09758.33
620555-2055557.42957.66
45min123595-2359565.92365.350.7066.2665.680.70
223095-2309564.52664.86
323424-2342465.44565.77
423377-2337765.31465.62
523432-2343265.46765.80
623411-2341165.40965.74
60min125319-2531970.73970.431.4771.1970.871.47
225901-2590172.36572.81
325080-2508070.07270.51
424867-2486769.47669.90
525075-2507570.05870.50
625012-2501269.88270.32
90min127164-2716475.89474.811.4776.4675.371.46
226264-2626473.38073.94
326727-2672774.67375.22
426393-2639373.74074.27
527205-2720576.00976.56
626913-2691375.19375.75
120min128224-2822478.85678.111.7179.5578.791.69
227336-2733676.37577.06
327696-2769677.38078.06
427822-2782277.73378.39
527947-2794778.08278.76
628723-2872380.25080.93
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129070-2907081.21980.781.2082.0481.591.19
228310-2831079.09679.91
328728-2872880.26481.07
429031-2903181.11081.90
529036-2903681.12481.94
629297-2929781.85482.67
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.313302533299327903295532849329840.61
210.253274532775327600.07
单位质量响应值RSD%判断
3199.223196.100.07数据可信
加速6月-供试品溶液-2025072521批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16046-604616.96416.8910.2816.9616.9010.27
25216-521614.63514.64
36916-691619.40519.41
46423-642318.02218.02
55473-547315.35615.36
66054-605416.98716.99
10min111238-1123831.53234.119.7231.5634.149.72
211293-1129331.68631.71
312622-1262235.41535.45
414264-1426440.02240.05
512227-1222734.30734.33
611303-1130331.71431.74
15min115309-1530942.95443.051.9043.0443.141.90
215439-1543943.31943.40
315649-1564943.90844.00
415375-1537543.14043.24
515491-1549143.46543.55
614801-1480141.52941.61
20min117908-1790850.24749.702.6050.4049.862.59
218354-1835451.49851.65
318051-1805150.64850.81
417347-1734748.67348.84
517461-1746148.99349.15
617168-1716848.17148.32
30min121288-2128859.73158.802.6759.9759.042.66
221585-2158560.56460.80
321433-2143360.13760.39
420759-2075958.24658.50
520400-2040057.23957.48
620263-2026356.85557.09
45min124287-2428768.14566.822.6268.4867.162.61
224624-2462469.09169.43
324060-2406067.50867.86
423388-2338865.62365.97
522934-2293464.34964.68
623606-2360666.23466.56
60min125960-2596072.83971.932.7573.2972.382.74
226637-2663774.73975.19
325564-2556471.72872.19
425958-2595872.83473.29
524762-2476269.47869.92
624932-2493269.95570.39
90min127503-2750377.16976.432.3477.7477.002.33
228316-2831679.45080.03
327285-2728576.55777.14
426764-2676475.09575.67
526511-2651174.38574.94
627064-2706475.93776.49
120min128549-2854980.10479.052.6580.8079.742.64
229343-2934382.33283.04
328374-2837479.61380.32
427306-2730676.61677.32
527526-2752677.23377.91
627938-2793878.38979.07
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129425-2942582.56281.461.9083.3982.291.90
229654-2965483.20484.05
329332-2933282.30183.14
428378-2837879.62480.45
528357-2835779.56580.37
629057-2905781.52982.34
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