美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80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%
1 18.102029792032392036562028372024392030300.23
218.032020192018102019140.08
单位质量响应值RSD%判断
11217.1311198.780.12数据可信
加速6月-供试品溶液-2025010621批-磷酸盐溶液(pH7.8)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15205-52052.5992.515.612.602.505.62
25251-52512.6222.62
34620-46202.3072.31
45324-53242.6592.66
54853-48532.4232.42
64855-48552.4242.42
10min17680-76803.8353.883.283.863.913.21
28200-82004.0954.12
37716-77163.8533.88
47918-79183.9543.98
57486-74863.7383.77
67612-76123.8013.83
15min110087-100875.0375.152.925.115.222.90
210729-107295.3585.43
310349-103495.1685.24
410620-106205.3035.38
510006-100064.9975.07
610113-101135.0505.12
20min113378-133786.6816.822.456.816.952.43
213995-139956.9897.12
313594-135946.7886.91
414163-141637.0737.20
513477-134776.7306.85
613383-133836.6836.81
30min119021-190219.4989.833.169.7010.033.13
220256-2025610.11510.33
319462-194629.7199.92
420634-2063410.30410.51
519379-193799.6779.88
619352-193529.6649.86
45min130540-3054015.25115.643.8415.5615.963.81
232483-3248316.22116.55
331808-3180815.88416.19
432835-3283516.39716.72
530188-3018815.07515.38
630116-3011615.03915.35
60min141162-4116220.55520.823.5721.0321.303.55
242125-4212521.03621.54
341670-4167020.80921.29
444378-4437822.16122.67
540474-4047420.21120.69
640323-4032320.13620.61
极限145557-4555722.75023.474.1523.4524.184.12
248293-4829324.11624.85
347190-4719023.56524.28
450120-5012025.02825.78
545813-4581322.87723.58
644979-4497922.46123.16
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80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%
1 18.102020982023642022862025622021862022990.09
218.032029152020952025050.29
单位质量响应值RSD%判断
11176.7411231.560.35数据可信
长期6月-供试品溶液-2025010621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14888-48882.4422.5013.342.442.5013.30
24328-43282.1622.16
35635-56352.8152.81
45808-58082.9012.90
54179-41792.0882.09
65181-51812.5882.59
10min17341-73413.6673.809.633.693.829.59
26853-68533.4233.45
38324-83244.1584.19
48451-84514.2224.25
56751-67513.3723.40
67875-78753.9343.96
15min111078-110785.5345.746.585.605.806.59
210859-108595.4245.49
312126-121266.0576.13
412394-123946.1916.27
510544-105445.2675.33
611895-118955.9426.01
20min115321-153217.6537.894.277.788.024.34
215065-150657.5267.65
316395-163958.1908.33
416676-166768.3308.48
515240-152407.6137.73
616063-160638.0248.16
30min121585-2158510.78311.223.7711.0011.443.80
221744-2174410.86211.07
323155-2315511.56711.80
423627-2362711.80312.04
521878-2187810.92911.13
622790-2279011.38411.61
45min132335-3233516.15316.763.2516.4917.113.29
232848-3284816.40916.74
334297-3429717.13317.50
435128-3512817.54817.92
532718-3271816.34416.67
634001-3400116.98517.34
60min141694-4169420.82821.773.8521.3422.303.81
245766-4576622.86223.37
344107-4410722.03322.59
444624-4462422.29122.86
541511-4151120.73621.24
643772-4377221.86622.41
极限146889-4688923.42324.523.0324.1725.293.03
248517-4851724.23625.00
350734-5073425.34426.14
450681-5068125.31726.13
548363-4836324.15924.90
649319-4931924.63725.42
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)80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%
1 18.102020402018942024842023982020392021710.13
218.032031662024812028240.24
单位质量响应值RSD%判断
11169.6711249.250.51数据可信
中间条件6月-供试品溶液-2025010621批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14511-45112.2522.188.482.252.188.50
24842-48422.4182.42
34723-47232.3582.36
44153-41532.0742.07
54022-40222.0082.01
63981-39811.9881.99
10min17537-75373.7633.773.873.793.803.86
27845-78453.9173.94
37772-77723.8813.91
47304-73043.6473.67
57758-77583.8743.90
67117-71173.5543.58
15min110391-103915.1885.333.905.265.403.87
211162-111625.5735.64
311174-111745.5795.65
410730-107305.3585.42
510245-102455.1155.18
610345-103455.1655.23
20min114035-140357.0087.273.397.137.393.40
214792-147927.3867.52
315102-151027.5417.67
414682-146827.3317.45
514883-148837.4317.55
613871-138716.9267.04
30min120972-2097210.47110.701.9510.6710.901.99
221783-2178310.87611.09
322075-2207511.02211.24
421281-2128110.62610.83
521283-2128310.62710.83
621161-2116110.56610.76
45min131828-3182815.89216.111.3616.2116.441.39
232705-3270516.33016.67
332818-3281816.38616.72
432422-3242216.18816.51
531955-3195515.95516.28
631878-3187815.91716.23
60min142857-4285721.39921.721.1421.8922.221.15
243273-4327321.60622.12
344280-4428022.10922.63
443817-4381721.87822.38
543273-4327321.60622.11
643509-4350921.72422.21
极限147970-4797023.95224.581.5124.6825.331.51
249388-4938824.66025.42
350259-5025925.09525.86
449053-4905324.49225.24
549345-4934524.63825.38
649370-4937024.65125.38
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