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%
118.102043902042242042122039072039162041300.11
218.032046272044622045440.06
单位质量响应值RSD%判断
11277.9011344.650.42数据可信
加速6月-供试品溶液-2024123121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%
5min13184-31841.5751.828.601.581.828.52
23966-39661.9621.96
33720-37201.8411.84
43687-36871.8241.82
54036-40361.9972.00
63472-34721.7181.72
10min17422-74223.6724.117.783.694.137.77
28794-87944.3514.37
38792-87924.3504.37
48462-84624.1874.21
58805-88054.3574.38
67563-75633.7423.76
15min113726-137266.7927.203.776.857.273.79
215142-151427.4927.56
315005-150057.4257.49
414341-143417.0967.16
514902-149027.3747.44
614231-142317.0427.10
20min116772-167728.2998.632.528.438.782.59
217974-179748.8949.05
317699-176998.7588.91
417590-175908.7048.85
517558-175588.6888.84
617083-170838.4538.59
30min129042-2904214.37013.782.2614.6014.022.19
227934-2793413.82214.07
327500-2750013.60713.86
427411-2741113.56313.81
527862-2786213.78614.04
627364-2736413.54013.77
45min134686-3468617.16317.471.5217.5517.871.51
236100-3610017.86318.27
335628-3562817.62918.03
435069-3506917.35217.75
534858-3485817.24817.65
635558-3555817.59417.98
60min148340-4834023.91924.251.1924.5024.841.16
249227-4922724.35824.96
349422-4942224.45425.05
449429-4942924.45825.04
548210-4821023.85524.45
649463-4946324.47525.05
极限151973-5197325.71726.261.7326.5627.121.71
254725-5472527.07827.95
353162-5316226.30527.17
452967-5296726.20927.07
552573-5257326.01426.87
653072-5307226.26127.11
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%
118.102044842041932041302040722040952041950.09
218.032034892035852035370.04
单位质量响应值RSD%判断
11281.4911288.800.05数据可信
长期6月-供试品溶液-2024123121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%
5min15210-52102.5842.1615.662.582.1615.65
23808-38081.8891.89
33632-36321.8011.80
45137-51372.5482.55
54418-44182.1912.19
63955-39551.9611.96
10min110631-106315.2724.925.285.304.945.31
29851-98514.8864.91
39254-92544.5904.61
410409-104095.1625.19
59836-98364.8784.90
69508-95084.7154.74
15min113544-135446.7176.454.926.806.534.91
212425-124256.1626.24
312254-122546.0776.15
413619-136196.7546.84
513579-135796.7356.81
612629-126296.2636.34
20min123372-2337211.59111.114.5111.7511.264.51
221419-2141910.62310.77
321512-2151210.66910.81
423572-2357211.69111.85
522935-2293511.37511.53
621545-2154510.68510.83
30min129326-2932614.54414.122.5314.8314.392.55
227934-2793413.85414.12
328003-2800313.88814.15
428879-2887914.32314.61
529072-2907214.41814.70
627572-2757213.67413.94
45min138994-3899419.33919.141.7319.7919.581.78
238138-3813818.91519.33
337828-3782818.76119.17
438910-3891019.29719.75
539582-3958219.63120.07
638161-3816118.92619.34
60min146997-4699723.30822.512.1323.9823.152.16
244647-4464722.14322.77
344353-4435321.99722.62
445592-4559222.61123.28
545777-4577722.70323.36
644902-4490222.26922.89
极限152059-5205925.81925.631.1926.7426.521.24
250771-5077125.18026.05
351133-5113325.35926.22
452294-5229425.93526.85
552163-5216325.87026.78
651616-5161625.59926.47
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%
118.102026532033772029092026192025112028140.18
218.032036712035202035960.06
单位质量响应值RSD%判断
11205.1911292.070.55数据可信
中间条件6月-供试品溶液-2024123121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%
5min13906-39061.9442.1112.311.942.1012.38
23516-35161.7491.75
34566-45662.2722.27
44978-49782.4772.48
54029-40292.0052.00
64392-43922.1852.19
10min19420-94204.6874.785.334.714.805.41
28974-89744.4654.48
39935-99354.9434.97
410428-104285.1895.22
59512-95124.7334.76
69324-93244.6394.66
15min112549-125496.2446.323.646.326.403.65
212153-121536.0476.12
313088-130886.5126.59
413416-134166.6756.76
512496-124966.2186.29
612505-125056.2226.30
20min120485-2048510.19310.012.7210.3410.162.72
219657-196579.7819.92
320582-2058210.24110.39
420728-2072810.31410.47
519850-198509.87710.02
619418-194189.6629.81
30min125866-2586612.87012.942.5613.1313.202.58
225741-2574112.80813.05
326436-2643613.15413.42
427152-2715213.51013.78
525497-2549712.68612.94
625407-2540712.64212.89
45min141629-4162920.71321.093.0621.1121.503.03
242812-4281221.30221.69
344461-4446122.12222.53
442673-4267321.23321.66
542187-4218720.99121.39
640592-4059220.19720.59
60min149039-4903924.40024.702.2925.0325.342.28
248635-4863524.19924.82
349791-4979124.77425.43
451395-5139525.57326.23
550489-5048925.12225.75
648533-4853324.14824.77
极限153455-5345526.59726.721.5827.5027.631.57
253171-5317126.45627.35
353343-5334326.54227.48
455253-5525327.49228.44
552944-5294426.34327.25
654020-5402026.87927.76
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