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%
118.352063312060072064872062002057182061490.15
218.392050112044372047240.20
单位质量响应值RSD%判断
11234.2811132.350.65数据可信
长期24月-供试品溶液-2023082221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%
5min15153-51532.4152.656.202.412.656.24
25499-54992.5772.58
35778-57782.7072.71
46044-60442.8322.83
55995-59952.8092.81
65418-54182.5392.54
10min18166-81663.8264.165.823.854.195.87
28622-86224.0404.07
38709-87094.0814.11
49407-94074.4084.44
59548-95484.4744.51
68827-88274.1364.16
15min112539-125395.8756.223.465.946.303.47
213648-136486.3956.47
313173-131736.1736.25
413095-130956.1366.22
513826-138266.4796.56
613425-134256.2916.36
20min115286-152867.1637.573.817.307.723.80
216126-161267.5567.70
315970-159707.4837.63
416260-162607.6197.77
517196-171968.0588.21
616126-161267.5567.70
30min124781-2478111.61212.135.4111.8312.365.35
225604-2560411.99712.23
325970-2597012.16912.40
426390-2639012.36612.60
528280-2828013.25113.49
624309-2430911.39111.62
45min133682-3368215.78316.573.7316.1316.933.72
236489-3648917.09817.46
335614-3561416.68817.05
436052-3605216.89317.26
536587-3658717.14417.53
633761-3376115.82016.17
60min147721-4772122.36122.192.9222.8822.732.91
247443-4744322.23122.78
346584-4658421.82822.38
448300-4830022.63223.19
548968-4896822.94523.53
645060-4506021.11421.64
极限154295-5429525.44125.072.2126.2125.872.18
254479-5447925.52826.33
353799-5379925.20926.00
452846-5284624.76225.57
554201-5420125.39726.23
651413-5141324.09124.86
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%
118.352056582087042058072057342058352063480.64
218.392036852033642035240.12
单位质量响应值RSD%判断
11245.1211067.101.13数据可信
长期24月-供试品溶液-2023082221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%
5min15624-56242.6422.644.512.642.644.51
25368-53682.5222.52
35309-53092.4942.49
45652-56522.6552.65
55966-59662.8022.80
65822-58222.7352.73
10min18891-88914.1764.261.834.214.281.79
29014-90144.2344.26
39015-90154.2354.26
48913-89134.1874.22
59238-92384.3394.37
69284-92844.3614.39
15min113584-135846.3816.392.546.466.472.54
213210-132106.2056.28
313220-132206.2106.28
413831-138316.4976.57
514075-140756.6126.69
613728-137286.4496.53
20min116057-160577.5437.773.507.697.923.47
216233-162337.6257.77
316083-160837.5557.70
417268-172688.1118.26
517301-173018.1278.28
616356-163567.6837.83
30min125433-2543311.94712.244.9812.1812.484.94
224531-2453111.52311.75
325559-2555912.00612.23
425683-2568312.06412.30
528129-2812913.21313.46
627057-2705712.71012.95
45min135817-3581716.82516.792.2917.1917.162.28
234872-3487216.38116.74
334818-3481816.35516.72
435741-3574116.78917.16
536346-3634617.07317.46
636909-3690917.33817.71
60min145856-4585621.54021.984.4022.0922.544.37
245187-4518721.22621.76
344213-4421320.76921.31
447350-4735022.24222.80
549463-4946323.23523.81
648701-4870122.87723.45
极限153372-5337225.07124.582.5325.8625.382.53
251391-5139124.14024.91
350469-5046923.70724.48
451832-5183224.34725.15
552927-5292724.86225.70
653970-5397025.35226.18
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