贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.26 2861582861362860892860562861852861250.02
210.252870612870172870390.02
单位质量响应值RSD%判断
27887.4328003.800.30数据可信
供试品溶液-2024090421批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12300-23001.6412.2637.611.642.2637.59
22696-26961.9241.92
32619-26191.8691.87
42782-27821.9851.99
55537-55373.9523.95
63028-30282.1612.16
10min15864-58644.1854.046.714.194.056.73
25786-57864.1294.13
35828-58284.1594.16
46084-60844.3424.35
55039-50393.5963.60
65396-53963.8513.85
15min17293-72935.2055.241.645.215.251.63
27282-72825.1975.21
37493-74935.3485.36
47495-74955.3495.36
57292-72925.2045.22
67210-72105.1465.16
20min19230-92306.5875.826.896.615.846.87
27833-78335.5905.61
37989-79895.7025.72
47942-79425.6685.69
57676-76765.4785.50
68275-82755.9065.92
30min18413-84136.0046.183.866.036.203.84
28554-85546.1056.13
39269-92696.6156.64
48797-87976.2786.31
58515-85156.0776.11
68386-83865.9856.01
45min19145-91456.5276.553.876.576.593.85
29304-93046.6406.68
38545-85456.0986.14
49622-96226.8676.91
59299-92996.6366.68
69168-91686.5436.58
60min19641-96416.8816.617.746.936.667.66
29739-97396.9507.00
37843-78435.5975.65
49503-95036.7826.83
59615-96156.8626.91
69262-92626.6106.66
极限110627-106277.5847.034.247.657.094.24
29766-97666.9707.03
39641-96416.8816.94
49796-97966.9917.05
59389-93896.7016.76
69885-98857.0557.12
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.26 2874832870372874132871542871462872470.07
210.252872662872462872560.01
单位质量响应值RSD%判断
27996.7828024.980.08数据可信
供试品溶液-2024090421批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12216-22161.5781.8315.061.581.8314.97
23209-32092.2852.28
32165-21651.5421.54
42439-24391.7371.74
52640-26401.8801.88
62740-27401.9511.95
10min15763-57634.1034.077.984.114.087.91
26532-65324.6514.65
35260-52603.7453.75
45695-56954.0554.06
55315-53153.7843.79
65746-57464.0914.09
15min16581-65814.6865.066.024.705.075.98
27517-75175.3525.36
36807-68074.8474.86
47475-74755.3225.33
56784-67844.8304.84
67483-74835.3285.34
20min18423-84235.9975.644.806.015.664.76
28123-81235.7845.80
38051-80515.7325.75
47308-73085.2035.22
57880-78805.6115.63
67734-77345.5075.53
30min19098-90986.4786.115.786.516.145.77
29260-92606.5936.62
38051-80515.7325.76
48473-84736.0336.06
58139-81395.7955.82
68475-84756.0346.06
45min19543-95436.7957.0411.946.837.0811.86
29311-93116.6306.67
39616-96166.8476.88
412283-122838.7468.78
59297-92976.6206.66
69292-92926.6166.65
60min19442-94426.7236.732.886.776.782.88
29652-96526.8726.92
39233-92336.5746.62
49743-97436.9376.99
59603-96036.8376.88
69033-90336.4326.48
极限19662-96626.8796.782.786.946.842.78
29538-95386.7916.85
39731-97316.9296.99
49784-97846.9667.03
59077-90776.4636.52
69377-93776.6776.74
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