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%
118.102042732040072043292040452035382040380.16
218.032031022033532032280.09
单位质量响应值RSD%判断
11272.8211271.660.01数据可信
加速6月-供试品溶液-2025010221批-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%
5min13852-38521.9131.8214.001.911.8213.89
23357-33571.6671.67
34196-41962.0832.08
43618-36181.7961.80
54160-41602.0662.07
62852-28521.4161.42
10min19233-92334.5844.513.274.614.533.34
28906-89064.4224.44
39467-94674.7014.72
48942-89424.4404.46
59270-92704.6034.63
68655-86554.2974.31
15min112411-124116.1626.102.196.236.172.21
212126-121266.0216.09
312558-125586.2356.31
412583-125836.2486.32
512106-121066.0116.08
611933-119335.9255.99
20min116790-167908.3378.381.778.488.521.77
216923-169238.4038.54
317312-173128.5968.74
417040-170408.4618.60
516758-167588.3218.46
616428-164288.1578.29
30min121597-2159710.72310.721.2210.9610.951.25
221495-2149510.67310.90
322105-2210510.97611.22
421437-2143710.64410.88
521386-2138610.61910.85
621507-2150710.67910.90
45min132681-3268116.22716.201.1716.5816.551.14
232557-3255716.16516.51
332792-3279216.28216.64
432743-3274316.25816.61
531921-3192115.84916.20
633049-3304916.40916.75
60min145707-4570722.69422.591.0423.2323.121.04
245422-4542222.55323.08
345706-4570622.69423.24
445993-4599322.83623.37
544620-4462022.15522.68
645512-4551222.59823.12
极限149483-4948324.56924.591.4825.3525.371.47
249793-4979324.72325.50
349927-4992724.79025.58
450555-5055525.10125.89
548748-4874824.20424.98
648644-4864424.15324.92
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%
118.102027672026002026322025532025242026150.05
218.032043262044782044020.06
单位质量响应值RSD%判断
11194.2011336.770.90数据可信
长期6月-供试品溶液-2025010221批-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%
5min14913-49132.4411.8720.382.441.8720.35
23715-37151.8461.85
33186-31861.5831.58
44423-44232.1982.20
52933-29331.4571.46
63377-33771.6781.68
10min110768-107685.3504.7711.325.384.7911.34
210989-109895.4605.48
38956-89564.4504.47
49730-97304.8344.86
58721-87214.3334.35
68419-84194.1834.20
15min113670-136706.7926.327.876.886.407.93
214059-140596.9857.07
312125-121256.0246.09
412987-129876.4526.53
511678-116785.8025.87
611826-118265.8765.94
20min121063-2106310.4659.965.3510.6310.105.43
221561-2156110.71210.87
319327-193279.6029.74
420135-2013510.00410.15
519006-190069.4439.57
619145-191459.5129.64
30min126698-2669813.26512.713.7313.5412.973.80
226764-2676413.29713.58
324722-2472212.28312.52
425240-2524012.54012.80
524566-2456612.20512.44
625522-2552212.68012.92
45min135437-3543717.60617.212.8718.0317.602.95
236091-3609117.93118.36
334427-3442717.10517.48
434573-3457317.17717.58
533857-3385716.82117.19
633406-3340616.59716.97
60min149974-4997424.82924.531.8225.4525.111.90
250927-5092725.30225.93
348781-4878124.23624.80
448912-4891224.30124.89
548655-4865524.17424.73
648954-4895424.32224.88
极限153974-5397426.81626.491.9527.7127.342.00
255085-5508527.36828.27
352714-5271426.19027.03
453018-5301826.34127.20
552277-5227725.97326.80
652790-5279026.22827.06
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%
118.102036162035232035052034292035842035310.04
218.032026072032832029450.24
单位质量响应值RSD%判断
11244.8111255.960.08数据可信
中间条件6月-供试品溶液-2025010221批-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%
5min13759-37591.8701.7812.531.871.7812.38
23616-36161.7991.80
33010-30101.4971.50
43407-34071.6951.69
53307-33071.6451.65
64311-43112.1452.14
10min18649-86494.3034.579.814.324.599.87
29027-90274.4914.51
38648-86484.3024.32
49037-90374.4964.51
58795-87954.3754.39
610998-109985.4715.50
15min111404-114045.6735.903.535.745.973.56
211791-117915.8665.94
311914-119145.9275.99
411870-118705.9055.97
511579-115795.7605.83
612621-126216.2796.36
20min117210-172108.5628.932.558.699.062.60
217791-177918.8518.99
317929-179298.9199.05
418228-182289.0689.20
517921-179218.9159.05
618578-185789.2429.40
30min122290-2229011.08911.241.4711.3211.471.54
222372-2237211.13011.36
322463-2246311.17511.40
422630-2263011.25811.49
522580-2258011.23311.46
623218-2321811.55111.81
45min132455-3245516.14616.561.6316.5016.921.66
233305-3330516.56916.93
332883-3288316.35916.71
433843-3384316.83617.20
533355-3335516.59416.95
633832-3383216.83117.22
60min142203-4220320.99521.691.8821.5222.231.88
244124-4412421.95122.49
343705-4370521.74222.28
444266-4426622.02222.57
543057-4305721.42021.96
644205-4420521.99122.56
极限149180-4918024.46625.061.8325.2325.841.78
251092-5109225.41726.20
350915-5091525.32926.11
451398-5139825.57026.36
550180-5018024.96425.74
649419-4941924.58525.40
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