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D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352046012044482045632042742041962044160.09
218.392085942086452086200.02
单位质量响应值RSD%判断
11139.8411344.211.29数据可信
长期24月-供试品溶液-2023082021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%
5min15926-59262.7622.696.082.762.696.05
25253-52532.4492.45
35989-59892.7922.79
46091-60912.8392.84
55398-53982.5162.52
65955-59552.7762.78
10min19280-92804.3264.204.294.364.244.36
28720-87204.0654.09
39492-94924.4254.46
49195-91954.2864.32
58441-84413.9353.96
68976-89764.1844.22
15min113102-131026.1086.232.866.196.312.84
213048-130486.0826.15
313537-135376.3106.39
413883-138836.4726.55
512965-129656.0446.12
613680-136806.3776.45
20min116510-165107.6967.682.997.847.832.96
216365-163657.6297.77
316949-169497.9018.05
417018-170187.9338.08
515654-156547.2977.44
616413-164137.6517.80
30min126855-2685512.51912.495.5012.7512.725.45
225473-2547311.87412.10
328388-2838813.23313.47
427870-2787012.99213.23
524603-2460311.46911.69
627566-2756612.85013.08
45min138249-3824917.83017.034.2418.2017.404.21
234387-3438716.03016.39
336646-3664617.08317.47
437311-3731117.39317.78
534936-3493616.28616.63
637642-3764217.54717.92
60min149044-4904422.86222.702.4423.4323.262.40
246621-4662121.73322.27
349269-4926922.96723.54
449416-4941623.03623.61
549818-4981823.22323.75
648009-4800922.38022.95
极限153676-5367625.02125.073.3425.8425.883.29
251469-5146923.99324.77
353371-5337124.87925.71
454700-5470025.49926.33
552749-5274924.58925.38
656728-5672826.44427.26
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D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352057432053732055342056002054582055420.07
218.392037002036482036740.02
单位质量响应值RSD%判断
11201.2011075.260.80数据可信
长期24月-供试品溶液-2023082021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%
5min15836-58362.7462.687.512.752.687.46
26296-62962.9622.96
35702-57022.6832.68
45918-59182.7842.78
55210-52102.4512.45
65198-51982.4462.45
10min19201-92014.3294.215.944.364.245.89
29820-98204.6204.65
38825-88254.1524.18
48986-89864.2284.26
58243-82433.8783.91
68675-86754.0814.11
15min114119-141196.6436.414.346.726.494.38
214477-144776.8116.90
313549-135496.3756.45
413600-136006.3986.48
512979-129796.1066.18
613034-130346.1326.20
20min116717-167177.8657.713.638.027.863.65
217325-173258.1518.31
316579-165797.8007.95
415836-158367.4507.60
515883-158837.4737.61
615961-159617.5097.65
30min127356-2735612.87012.715.4813.1112.945.46
229017-2901713.65213.90
327364-2736412.87413.11
427754-2775413.05813.29
525527-2552712.01012.23
625030-2503011.77612.00
45min136730-3673017.28116.991.5617.6617.361.60
236457-3645717.15217.55
335807-3580716.84617.22
436653-3665317.24417.62
535543-3554316.72217.08
635504-3550416.70417.06
60min148863-4886322.98922.611.9223.5623.181.93
248309-4830922.72823.32
348732-4873222.92723.49
448218-4821822.68523.25
546313-4631321.78922.33
647944-4794422.55723.10
极限153540-5354025.18925.802.3026.0226.612.20
255047-5504725.89826.74
354487-5448725.63526.45
455183-5518325.96226.78
557021-5702126.82727.61
653762-5376225.29426.08
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