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%
19.926359763621629026352863300633900.48
210.016513265300652160.19
单位质量响应值RSD%判断
6390.126515.081.37数据可信
供试品溶液-25022703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%
5min16201-62018.62310.1413.158.6210.1413.16
28504-850411.82611.83
36873-68739.5589.56
47192-719210.00110.00
56583-65839.1549.15
68408-840811.69211.69
10min113779-1377919.16119.574.9619.1819.594.97
215224-1522421.17021.19
313498-1349818.77018.79
413975-1397519.43419.45
513399-1339918.63318.65
614552-1455220.23620.26
15min119498-1949827.11426.473.9627.1626.523.97
219842-1984227.59227.65
318049-1804925.09925.15
419049-1904926.48926.54
518192-1819225.29825.34
619571-1957127.21527.27
20min121549-2154929.96631.022.7130.0631.122.71
223049-2304932.05232.15
321900-2190030.45430.54
422691-2269131.55431.65
521901-2190130.45530.54
622767-2276731.66031.76
30min126168-2616836.38937.071.2536.5337.211.26
226965-2696537.49737.65
326658-2665837.07037.21
426603-2660336.99437.14
526465-2646536.80236.94
627075-2707537.65037.80
45min130219-3021942.02242.871.3642.2243.081.37
231041-3104143.16543.38
330814-3081442.85043.05
431246-3124643.45043.66
530456-3045642.35242.55
631204-3120443.39243.61
60min133176-3317646.13446.811.3446.4147.091.34
234017-3401747.30447.59
333683-3368346.83947.11
433769-3376946.95947.24
533111-3311146.04446.32
634234-3423447.60647.89
90min137056-3705651.53052.360.8051.8852.710.81
237899-3789952.70253.07
337789-3778952.54952.90
437764-3776452.51452.87
537684-3768452.40352.75
637714-3771452.44552.81
120min139530-3953054.97055.600.7455.4156.040.74
240174-4017455.86656.32
340292-4029256.03056.47
440116-4011655.78556.23
539722-3972255.23755.67
640046-4004655.68856.14
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140724-4072456.63056.780.6557.1657.320.65
241243-4124357.35257.90
340889-4088956.86057.39
440870-4087056.83457.37
540851-4085156.80757.33
640425-4042556.21556.76
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%
19.926405563715636536363463813637740.27
210.016358463508635460.09
单位质量响应值RSD%判断
6428.836348.250.90数据可信
供试品溶液-25022703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%
5min112882-1288218.09216.2415.7518.0916.2415.74
213105-1310518.40518.41
312453-1245317.49017.49
411035-1103515.49815.50
58193-819311.50711.51
611720-1172016.46016.46
10min121878-2187830.72730.047.9830.7630.077.98
222816-2281632.04432.07
322561-2256131.68631.72
422022-2202230.92930.95
518190-1819025.54725.57
620878-2087829.32229.35
15min127799-2779939.04338.305.4739.1238.385.48
228599-2859940.16640.25
328471-2847139.98640.07
427290-2729038.32838.41
524529-2452934.45034.51
626953-2695337.85437.93
20min132042-3204245.00244.244.1845.1544.384.19
232990-3299046.33346.48
332522-3252245.67645.82
431092-3109243.66843.81
529333-2933341.19741.32
631025-3102543.57343.71
30min137430-3743052.56952.002.4752.7952.212.49
238093-3809353.50053.73
337582-3758252.78253.01
437126-3712652.14252.36
535599-3559949.99750.19
636303-3630350.98651.20
45min142480-4248059.66259.251.7659.9759.551.77
243031-4303160.43560.75
342954-4295460.32760.64
441826-4182658.74359.04
541365-4136558.09658.37
641446-4144658.20958.51
60min145668-4566864.13963.731.2964.5564.141.30
246033-4603364.65265.07
345931-4593164.50864.92
445000-4500063.20163.60
545070-4507063.29963.67
644575-4457562.60463.00
90min149421-4942169.41069.981.1169.9370.481.11
250623-5062371.09871.62
350211-5021170.51971.04
449910-4991070.09770.60
549705-4970569.80970.28
649091-4909168.94669.44
120min152370-5237073.55273.531.1574.1874.151.17
253197-5319774.71375.36
352918-5291874.32174.96
452012-5201273.04973.67
552023-5202373.06473.65
651613-5161372.48873.10
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153078-5307874.54674.731.3075.3075.471.30
253990-5399075.82776.60
353627-5362775.31776.08
453053-5305374.51175.25
553502-5350275.14175.85
651993-5199373.02273.76
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