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%
118.102040272035262035852033332035502036040.13
218.032033022029832031420.12
单位质量响应值RSD%判断
11248.8411266.890.12数据可信
加速6月-供试品溶液-2025010421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%
5min16937-69373.4493.451.603.453.451.62
26896-68963.4283.43
36748-67483.3553.35
47019-70193.4903.49
56931-69313.4463.45
67067-70673.5133.51
10min19989-99894.9665.022.225.005.062.26
210377-103775.1595.20
39973-99734.9585.00
410017-100174.9805.02
59844-98444.8944.93
610372-103725.1565.20
15min112691-126916.3096.251.926.406.351.89
212964-129646.4456.54
312420-124206.1756.27
412325-123256.1276.22
512402-124026.1666.26
612664-126646.2966.39
20min117536-175368.7188.691.328.888.851.30
217854-178548.8769.04
317298-172988.6008.76
417605-176058.7528.91
517328-173288.6158.78
617252-172528.5778.74
30min122875-2287511.37211.071.7111.6311.331.67
222570-2257011.22111.49
322251-2225111.06211.32
422010-2201010.94211.20
522011-2201110.94311.20
621913-2191310.89411.16
45min133454-3345416.63216.501.4317.0216.881.42
233353-3335316.58216.97
333249-3324916.53016.91
432759-3275916.28616.67
532494-3249416.15416.53
633783-3378316.79517.18
60min145716-4571622.72822.431.1723.3022.991.15
245339-4533922.54023.11
345401-4540122.57123.13
444756-4475622.25122.81
544252-4425222.00022.56
645186-4518622.46423.03
极限150641-5064125.17625.251.4726.0026.061.43
250701-5070125.20626.03
352142-5214225.92326.74
450635-5063525.17325.98
549859-4985924.78825.59
650756-5075625.23326.05
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%
118.102029122030722030592028272030482029840.06
218.032036722033562035140.11
单位质量响应值RSD%判断
11214.5911287.520.46数据可信
长期6月-供试品溶液-2025010421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%
5min14894-48942.4352.847.742.432.847.80
25588-55882.7802.78
36130-61303.0493.05
45774-57742.8722.87
55802-58022.8862.89
66037-60373.0033.00
10min19077-90774.5154.843.714.544.883.77
29777-97774.8644.89
310176-101765.0625.10
49719-97194.8354.87
59859-98594.9044.94
69805-98054.8784.91
15min112196-121966.0676.332.906.146.412.92
212760-127606.3486.43
312806-128066.3706.46
412899-128996.4176.50
512416-124166.1766.26
613237-132376.5856.67
20min116335-163358.1268.643.148.278.793.14
217407-174078.6598.81
317842-178428.8769.04
417703-177038.8078.96
517614-176148.7628.92
617264-172648.5888.75
30min121904-2190410.89611.281.7811.1311.531.81
222656-2265611.27011.52
322933-2293311.40811.67
422846-2284611.36511.62
523015-2301511.44911.70
622661-2266111.27311.53
45min133455-3345516.64216.921.2817.0017.301.29
234227-3422717.02717.40
334036-3403616.93217.32
433609-3360916.71917.10
534113-3411316.97017.35
634654-3465417.23917.62
60min145384-4538422.57723.121.9423.1223.681.92
245397-4539722.58323.15
346998-4699823.38023.95
447534-4753423.64624.21
546460-4646023.11223.68
647038-4703823.39923.97
极限150294-5029425.01925.341.0225.8126.161.02
250893-5089325.31726.13
351322-5132225.53126.36
451730-5173025.73426.56
550767-5076725.25426.08
650603-5060325.17326.01
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%
118.102025992023782027242026422024092025500.08
218.032010002009572009780.02
单位质量响应值RSD%判断
11190.6111146.870.28数据可信
中间条件6月-供试品溶液-2025010421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%
5min12976-29761.4911.8419.711.491.8419.67
23454-34541.7311.73
32919-29191.4631.46
43583-35831.7961.80
54477-44772.2442.24
64597-45972.3042.30
10min17249-72493.6334.039.793.654.059.82
27886-78863.9523.97
37392-73923.7043.72
47683-76833.8503.87
58946-89464.4834.51
69078-90784.5494.57
15min19889-98894.9565.358.895.015.428.95
210933-109335.4795.54
39710-97104.8664.92
410000-100005.0115.07
511701-117015.8645.94
611848-118485.9376.01
20min115824-158247.9308.124.808.048.244.90
216339-163398.1888.31
315041-150417.5377.65
416030-160308.0338.15
516613-166138.3258.47
617347-173478.6938.84
30min120354-2035410.20010.593.7710.4010.813.83
221387-2138710.71710.93
320043-2004310.04410.24
421215-2121510.63110.84
521793-2179310.92111.15
622063-2206311.05611.29
45min135521-3552117.80018.082.7718.1118.422.83
236131-3613118.10618.44
335139-3513917.60917.92
435175-3517517.62717.95
537522-3752218.80319.16
637019-3701918.55118.91
60min142956-4295621.52621.902.1022.0422.442.14
243452-4345221.77522.31
344050-4405022.07422.58
442491-4249121.29321.81
544337-4433722.21822.78
644954-4495422.52723.10
极限147970-4797024.03924.692.4524.7925.462.36
251438-5143825.77726.55
349213-4921324.66225.41
449573-4957324.84225.60
548890-4889024.50025.31
648496-4849624.30225.12
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