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%
118.102044202044882041902043292042152043280.07
218.032055812057612056710.07
单位质量响应值RSD%判断
11288.8411407.150.74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%
5min14149-41492.0462.134.762.052.134.66
24456-44562.1982.20
34631-46312.2842.28
44151-41512.0472.05
54136-41362.0402.04
64382-43822.1612.16
10min17842-78423.8683.982.503.894.002.52
28358-83584.1224.15
38243-82434.0664.09
47901-79013.8973.92
57981-79813.9363.96
68033-80333.9623.99
15min110828-108285.3415.392.685.415.462.61
210616-106165.2365.31
311083-110835.4665.54
411446-114465.6455.71
510791-107915.3225.39
610833-108335.3435.41
20min118308-183089.0309.302.609.159.422.59
219220-192209.4809.61
319484-194849.6109.74
418269-182699.0119.14
519006-190069.3749.50
618817-188179.2819.41
30min124007-2400711.84112.021.5712.0712.261.55
224795-2479512.22912.46
324910-2491012.28612.52
424065-2406511.86912.10
524287-2428711.97912.21
624209-2420911.94012.17
45min136701-3670118.10218.776.7818.4619.136.67
243128-4312821.27121.64
338149-3814918.81619.19
436860-3686018.18018.54
537385-3738518.43918.80
636110-3611017.81018.17
60min144976-4497622.18322.451.6622.7423.021.69
246846-4684623.10523.71
345838-4583822.60823.19
445090-4509022.23922.80
545489-4548922.43623.00
644821-4482122.10622.67
极限150715-5071525.01425.360.9725.8226.181.01
251893-5189325.59526.46
352000-5200025.64726.48
451315-5131525.30926.12
551021-5102125.16425.98
651532-5153225.41626.22
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%
118.102073622069252069132069082062972068810.19
218.032069392071432070410.07
单位质量响应值RSD%判断
11429.8911483.140.33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%
5min15576-55762.7242.7416.862.722.7416.84
25551-55512.7122.71
35807-58072.8372.84
45009-50092.4472.45
57264-72643.5493.55
64457-44572.1772.18
10min19781-97814.7784.755.224.814.785.30
29624-96244.7024.73
310319-103195.0415.07
49370-93704.5784.60
510224-102244.9955.03
68987-89874.3904.41
15min112809-128096.2586.233.996.346.314.05
212630-126306.1706.25
313217-132176.4576.54
412508-125086.1116.19
513375-133756.5346.63
611970-119705.8485.92
20min120159-201599.8489.673.1710.009.823.20
219480-194809.5179.67
320574-2057410.05110.21
419711-197119.6309.78
520079-200799.8099.98
618777-187779.1739.31
30min126281-2628112.83912.661.3113.1012.921.37
225977-2597712.69112.95
325966-2596612.68512.96
425783-2578312.59612.85
526130-2613012.76513.04
625308-2530812.36412.60
45min138763-3876318.93718.571.3019.3418.971.23
238060-3806018.59418.99
337787-3778718.46018.87
437918-3791818.52418.92
537294-3729418.21918.64
638270-3827018.69619.07
60min146731-4673122.83022.601.0223.4523.211.03
245893-4589322.42023.02
346943-4694322.93323.55
445777-4577722.36422.96
546052-4605222.49823.12
646169-4616922.55523.14
极限151390-5139025.10625.033.8525.9725.893.68
251611-5161125.21426.07
352610-5261025.70226.57
452154-5215425.47926.33
547336-4733623.12524.00
652359-5235925.57926.41
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