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10000
标示量(mg)1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%
19.923144231519312593128231467313940.38
210.013205631733318940.72
单位质量响应值RSD%判断
3164.723186.210.48数据可信
供试品溶液-25031901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%
5min15046-504614.25713.5212.6314.2613.5212.62
25292-529214.95214.95
34896-489613.83413.83
45105-510514.42414.42
53609-360910.19710.20
64757-475713.44113.44
10min19287-928726.24026.105.5526.2626.125.55
29394-939426.54326.57
39512-951226.87626.90
49488-948826.80826.83
58207-820723.18923.21
69526-952626.91526.94
15min111888-1188833.58934.042.7633.6634.112.76
212307-1230734.77334.84
312119-1211934.24234.31
412104-1210434.20034.27
511475-1147532.42232.48
612394-1239435.01935.09
20min113632-1363238.51739.772.2238.6439.902.23
214231-1423140.20940.34
314177-1417740.05740.18
414227-1422740.19840.32
513755-1375538.86438.97
614437-1443740.79140.92
30min115891-1589144.90046.321.8045.0946.511.79
216485-1648546.57846.77
316545-1654546.74846.94
416271-1627145.97346.17
516414-1641446.37746.55
616758-1675847.34947.54
45min118282-1828251.65553.452.6151.9253.712.61
219090-1909053.93854.21
318692-1869252.81453.08
419366-1936654.71854.99
518531-1853152.35952.61
619536-1953655.19955.47
60min120062-2006256.68558.591.7457.0358.941.73
220690-2069058.45958.82
320792-2079258.74759.10
421109-2110959.64360.00
520821-2082158.82959.17
620934-2093459.14959.51
90min122292-2229262.98664.551.3563.4365.001.34
222810-2281064.44964.91
322901-2290164.70665.16
422877-2287764.63865.10
523233-2323365.64466.08
622961-2296164.87665.34
120min123902-2390267.53568.171.2968.0868.731.29
223655-2365566.83767.40
324325-2432568.73069.29
424194-2419468.36068.93
524151-2415168.23868.78
624531-2453169.31269.88
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124333-2433368.75269.661.0569.4170.331.04
224520-2452069.28169.96
324563-2456369.40270.08
425068-2506870.82971.51
524823-2482370.13770.80
624611-2461169.53870.22
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10000
标示量(mg)1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%
19.923136031410311503145131245313230.40
210.013205732356322060.66
单位质量响应值RSD%判断
3157.563217.381.33数据可信
供试品溶液-25031901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%
5min16895-689519.41020.788.8719.4120.788.88
27603-760321.40321.40
38003-800322.52922.53
47811-781121.98821.99
56289-628917.70417.70
67686-768621.63621.64
10min112626-1262635.54337.213.5135.5837.243.50
213839-1383938.95738.99
313329-1332937.52237.56
413549-1354938.14138.18
512755-1275535.90635.94
613208-1320837.18137.22
15min116526-1652646.52246.782.9346.6146.872.93
217492-1749249.24149.34
316636-1663646.83146.93
416696-1669647.00047.10
516103-1610345.33145.42
616244-1624445.72845.83
20min117987-1798750.63452.252.6250.8052.422.62
219383-1938354.56454.75
318805-1880552.93753.12
418534-1853452.17452.35
518318-1831851.56651.73
618335-1833551.61451.79
30min121249-2124959.81760.421.6760.0760.681.67
222118-2211862.26362.54
321530-2153060.60860.87
421490-2149060.49560.76
521267-2126759.86860.12
621119-2111959.45159.71
45min123791-2379166.97367.181.9067.3367.551.90
224586-2458669.21169.59
323916-2391667.32567.69
424108-2410867.86568.23
523412-2341265.90666.26
623385-2338565.83066.19
60min125353-2535371.37071.781.3171.8372.251.31
226159-2615973.63974.13
325314-2531471.26071.74
425369-2536971.41571.89
525506-2550671.80172.26
625292-2529271.19871.67
90min127130-2713076.37276.501.5176.9677.101.52
227987-2798778.78579.40
327123-2712376.35376.95
426963-2696375.90276.50
526982-2698275.95676.54
626868-2686875.63576.22
120min127935-2793578.63879.511.4079.3580.231.40
228958-2895881.51882.26
328333-2833379.75980.48
428310-2831079.69480.42
527957-2795778.70079.41
627965-2796578.72379.44
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128369-2836979.86080.161.5980.7081.021.59
229303-2930382.48983.37
328127-2812779.17980.04
428677-2867780.72781.58
528213-2821379.42180.26
628175-2817579.31480.16
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