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%
1 10.083287333037329203344633106330760.69
2 10.053354133442334920.21
单位质量响应值RSD%判断
3281.353332.541.10数据可信
供试品溶液-25041502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%
5min18169-816922.16520.4513.8622.1620.4513.85
27866-786621.34321.34
37473-747320.27620.28
47756-775621.04421.04
58437-843722.89222.89
65517-551714.96914.97
10min113612-1361236.93335.547.1436.9735.577.15
213425-1342536.42636.46
313095-1309535.53035.56
413472-1347236.55336.59
513743-1374337.28937.33
611242-1124230.50330.53
15min116586-1658645.00244.884.3645.1044.974.37
217230-1723046.75046.85
316491-1649144.74544.84
416793-1679345.56445.66
516966-1696646.03346.13
615174-1517441.17141.25
20min119110-1911051.85151.412.7452.0251.582.76
219205-1920552.10852.28
319351-1935152.50552.67
418838-1883851.11351.28
519231-1923152.17952.36
617948-1794848.69848.84
30min122243-2224360.35159.801.8860.6160.061.89
221942-2194259.53559.80
321903-2190359.42959.68
422244-2224460.35460.61
522561-2256161.21461.48
621355-2135557.94258.17
45min124404-2440466.21566.891.5066.5867.241.51
224583-2458366.70067.06
324830-2483067.37167.72
425039-2503967.93868.30
524978-2497867.77268.14
624080-2408065.33665.66
60min126307-2630771.37871.540.3371.8572.010.34
226336-2633671.45771.93
326394-2639471.61472.08
426531-2653171.98672.46
526333-2633371.44971.93
626301-2630171.36271.79
90min128219-2821976.56677.060.7177.1677.650.71
228195-2819576.50177.09
328407-2840777.07677.66
428576-2857677.53478.13
528694-2869477.85578.45
628319-2831976.83777.39
120min129574-2957480.24280.581.0780.9681.301.08
229572-2957280.23780.95
329819-2981980.90781.62
429623-2962380.37581.10
530267-3026782.12382.85
629342-2934279.61380.29
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129964-2996481.30081.450.5282.1582.300.52
229824-2982480.92181.77
330247-3024782.06882.92
430074-3007481.59982.45
530112-3011281.70282.57
629900-2990081.12781.94
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%
1 10.083323333423331163297833282332060.51
2 10.053354333623335830.17
单位质量响应值RSD%判断
3294.253341.591.01数据可信
供试品溶液-25041901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%
5min18161-816122.07021.725.7222.0721.725.72
28176-817622.11022.11
38750-875023.66223.66
47596-759620.54220.54
57475-747520.21420.21
68036-803621.73221.73
10min113639-1363936.88437.132.8036.9237.162.81
213500-1350036.50836.54
314471-1447139.13439.17
413382-1338236.18936.22
513743-1374337.16537.20
613647-1364736.90536.94
15min116903-1690345.71045.931.5845.8146.031.59
216835-1683545.52645.62
317496-1749647.31447.42
416817-1681745.47845.57
517063-1706346.14346.24
616798-1679845.42645.52
20min119015-1901551.42251.751.3551.6051.921.35
218907-1890751.13051.30
319376-1937652.39852.58
418894-1889451.09551.26
519518-1951852.78252.95
619109-1910951.67651.85
30min121532-2153258.22859.491.4258.4959.761.42
222080-2208059.71059.97
322415-2241560.61660.89
422223-2222360.09760.35
521934-2193459.31659.58
621817-2181758.99959.26
45min124018-2401864.95166.221.4365.3166.581.43
224323-2432365.77666.13
325071-2507167.79968.17
424591-2459166.50166.86
524528-2452866.33066.69
624389-2438965.95466.31
60min125585-2558569.18970.631.3169.6571.101.31
225921-2592170.09770.57
326544-2654471.78272.27
426363-2636371.29371.76
526052-2605270.45270.92
626239-2623970.95771.43
90min126790-2679072.44775.502.2473.0376.092.23
227950-2795075.58476.17
328446-2844676.92677.53
427891-2789175.42576.01
528548-2854877.20277.79
627887-2788775.41476.00
120min129143-2914378.81179.210.9879.5179.920.98
229230-2923079.04679.76
329437-2943779.60680.34
429575-2957579.97980.69
529532-2953279.86380.58
628822-2882277.94378.65
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129136-2913678.79279.861.5979.6280.701.58
229262-2926279.13279.97
330048-3004881.25882.12
429984-2998481.08581.93
529795-2979580.57481.42
628964-2896478.32779.17
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%
1 10.083317933187331643294133077331100.32
2 10.053344833527334880.17
单位质量响应值RSD%判断
3284.723332.141.02数据可信
供试品溶液-25041902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%
5min16066-606616.45119.5510.2316.4519.5410.24
27629-762920.69020.69
38041-804121.80721.81
47092-709219.23419.23
56693-669318.15218.15
67720-772020.93720.94
10min112234-1223433.17934.974.0333.2135.004.04
213375-1337536.27336.31
313188-1318835.76635.80
413021-1302135.31335.35
512249-1224933.22033.25
613299-1329936.06736.10
15min115805-1580542.86444.082.2642.9544.172.26
216544-1654444.86844.96
316246-1624644.06044.16
416489-1648944.71944.81
515811-1581142.88042.97
616619-1661945.07145.17
20min118292-1829249.60850.522.0149.7650.682.01
219170-1917051.99052.16
318621-1862150.50150.67
418453-1845350.04550.21
518255-1825549.50849.67
618973-1897351.45551.63
30min121092-2109257.20258.131.1757.4458.381.17
221505-2150558.32258.58
321297-2129757.75858.01
421644-2164458.69958.95
521303-2130357.77458.01
621762-2176259.01959.28
45min123995-2399565.07565.781.3365.4166.131.34
224498-2449866.43966.79
323977-2397765.02665.38
424439-2443966.27966.63
523941-2394164.92965.26
624681-2468166.93667.29
60min125696-2569669.68870.200.9570.1370.660.95
226212-2621271.08871.55
325732-2573269.78670.24
426166-2616670.96371.42
525662-2566269.59670.04
625845-2584570.09270.56
90min127684-2768475.08075.610.6075.6476.180.60
227823-2782375.45776.04
327704-2770475.13475.71
427976-2797675.87276.45
528078-2807876.14876.71
628010-2801075.96476.55
120min129206-2920679.20879.151.4979.8979.851.48
229209-2920979.21679.92
328397-2839777.01377.71
429465-2946579.91080.61
529156-2915679.07279.76
629675-2967580.47981.19
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129458-2945879.89179.881.0480.7080.711.03
229700-2970080.54781.39
328897-2889778.37079.20
429684-2968480.50481.34
529365-2936579.63980.46
629624-2962480.34181.18
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