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%
118.102018832022462020312020762022372020950.08
218.032021172013662017420.27
单位质量响应值RSD%判断
11165.4711189.240.16数据可信
加速6月-供试品溶液-2025010521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%
5min16079-60793.0443.449.943.043.449.98
26990-69903.5003.50
36515-65153.2623.26
48109-81094.0604.06
56816-68163.4133.41
66709-67093.3593.36
10min110751-107515.3835.684.525.425.724.52
211965-119655.9916.03
311157-111575.5875.62
411977-119775.9976.04
511241-112415.6295.67
610986-109865.5015.54
15min114274-142747.1477.263.417.247.363.43
215050-150507.5367.64
314338-143387.1807.28
415184-151847.6037.71
514274-142747.1477.25
613932-139326.9767.07
20min116718-167188.3718.542.778.548.722.80
217802-178028.9149.10
316872-168728.4488.63
417454-174548.7408.94
516634-166348.3298.51
616791-167918.4088.58
30min127083-2708313.56113.682.8613.8313.962.84
228818-2881814.43014.72
327390-2739013.71513.99
427104-2710413.57213.87
526573-2657313.30613.58
626953-2695313.49613.77
45min135234-3523417.64318.013.1218.0618.443.11
237477-3747718.76619.21
335835-3583517.94418.37
437189-3718918.62219.07
534701-3470117.37617.80
635381-3538117.71618.14
60min147130-4713023.60023.902.3624.2124.532.37
249784-4978424.92925.59
348121-4812124.09624.72
447389-4738923.72924.38
546581-4658123.32523.94
647330-4733023.70024.32
极限153346-5334626.71226.632.1827.5927.522.19
255385-5538527.73328.67
352459-5245926.26827.16
453127-5312726.60227.52
552267-5226726.17227.04
652504-5250426.29127.17
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%
118.102036502034932034582033022034132034630.07
218.032022702026872024780.15
单位质量响应值RSD%判断
11241.0511230.060.07数据可信
长期6月-供试品溶液-2025010521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%
5min14461-44612.2222.6411.622.222.6411.70
25658-56582.8182.82
36137-61373.0573.06
45057-50572.5192.52
55641-56412.8102.81
64864-48642.4232.42
10min18633-86334.3004.483.364.334.523.40
29425-94254.6954.73
39019-90194.4934.53
49195-91954.5804.61
59046-90464.5064.54
68684-86844.3264.35
15min111749-117495.8536.1914.095.936.2713.87
212256-122566.1056.19
311828-118285.8925.98
411142-111425.5505.63
511683-116835.8205.90
615931-159317.9368.01
20min116068-160688.0048.513.668.148.663.64
217742-177428.8388.99
316966-169668.4518.60
417021-170218.4798.62
517761-177618.8478.99
616976-169768.4568.62
30min122788-2278811.35211.220.9811.5811.470.96
222622-2262211.26911.52
322436-2243611.17611.42
422144-2214411.03111.27
522597-2259711.25611.50
622591-2259111.25311.51
45min135207-3520717.53817.131.6617.8917.491.61
234962-3496217.41617.79
334052-3405216.96317.33
433960-3396016.91717.27
534276-3427617.07417.44
633824-3382416.84917.23
60min155187-5518727.49124.585.8728.0425.145.72
248909-4890924.36424.93
348223-4822324.02224.58
447957-4795723.88924.43
548134-4813423.97724.54
647659-4765923.74124.31
极限155098-5509827.44726.322.3428.3027.152.31
251896-5189625.85126.69
352222-5222226.01426.84
451940-5194025.87326.68
553382-5338226.59227.42
652452-5245226.12826.96
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%
118.102027592029752029712028252026582028380.07
218.032017762022592020180.17
单位质量响应值RSD%判断
11206.5211204.550.02数据可信
中间条件6月-供试品溶液-2025010521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%
5min15022-50222.5082.9621.162.512.9621.14
28243-82434.1174.12
36509-65093.2513.25
45081-50812.5382.54
55458-54582.7262.73
65280-52802.6372.64
10min19225-92254.6084.925.854.644.965.88
210809-108095.3995.44
310013-100135.0015.04
49428-94284.7094.74
510101-101015.0455.08
69564-95644.7774.81
15min112215-122156.1016.564.856.186.644.92
214066-140667.0267.13
313289-132896.6386.73
412677-126776.3326.41
513406-134066.6966.78
613110-131106.5486.63
20min120520-2052010.24910.652.5710.4010.812.61
221776-2177610.87711.06
321580-2158010.77910.94
421008-2100810.49310.64
521985-2198510.98111.14
621106-2110610.54210.70
30min125498-2549812.73613.523.7713.0013.803.76
227733-2773313.85214.16
327191-2719113.58113.87
426467-2646713.22013.49
528452-2845214.21114.49
627097-2709713.53413.81
45min137960-3796018.96019.613.0119.3620.043.01
240114-4011420.03620.49
337794-3779418.87719.31
439255-3925519.60720.02
540760-4076020.35920.80
639647-3964719.80320.23
60min146247-4624723.09923.621.9623.7124.271.97
247286-4728623.61824.30
347557-4755723.75324.40
446335-4633523.14323.78
548733-4873324.34125.01
647610-4761023.78024.42
极限152268-5226826.10727.022.6926.9827.932.67
254190-5419027.06728.01
352963-5296326.45427.36
454110-5411027.02727.92
556491-5649128.21629.15
654532-5453227.23728.14
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