贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院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%
19.952930702911672914372913572915092917080.27
29.952922492923622923060.03
单位质量响应值RSD%判断
29317.3929377.490.15数据可信
制剂处方摸索--供试品溶液-24022301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%
5min11232-12320.8370.9519.920.840.9519.60
21676-16761.1391.14
31654-16541.1241.12
41185-11850.8050.81
51040-10400.7070.71
61608-16081.0931.09
10min16339-63394.3084.401.714.324.411.71
26367-63674.3274.34
36584-65844.4744.49
46602-66024.4874.50
56509-65094.4234.43
66435-64354.3734.39
15min17859-78595.3415.236.535.405.296.49
26700-67004.5534.61
37904-79045.3715.43
48118-81185.5175.58
57746-77465.2645.32
67828-78285.3205.38
20min18473-84735.7585.479.095.875.598.89
28341-83415.6685.78
38353-83535.6775.80
46582-65824.4734.59
58449-84495.7425.86
68098-80985.5035.62
30min18944-89446.0785.977.526.266.157.34
27453-74535.0655.24
39215-92156.2626.45
49055-90556.1546.32
58964-89646.0926.27
69085-90856.1746.36
45min19115-91156.1946.321.386.446.561.27
29460-94606.4296.66
39202-92026.2546.51
49250-92506.2866.52
59370-93706.3686.61
69369-93696.3676.62
60min19483-94836.4446.581.316.766.901.18
29795-97956.6576.96
39684-96846.5816.91
49824-98246.6766.98
59613-96136.5336.85
69732-97326.6146.93
极限19754-97546.6296.581.217.026.971.14
29781-97816.6477.02
39732-97326.6147.01
49627-96276.5426.92
59756-97566.6307.02
69476-94766.4406.83
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院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%
19.953053913081993077343072123057853068640.40
29.953003963005003004480.03
单位质量响应值RSD%判断
30840.6030195.781.50数据可信
制剂处方摸索--供试品溶液-24022301批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12646-26461.7292.0214.621.732.0214.62
23701-37012.4192.42
33494-34942.2842.28
43210-32102.0982.10
52815-28151.8401.84
62651-26511.7331.73
10min13848-38482.5152.697.992.532.718.08
24600-46003.0063.03
34340-43402.8372.86
44264-42642.7872.81
53904-39042.5522.57
63770-37702.4642.48
15min14595-45953.0033.122.543.053.172.62
24918-49183.2143.27
34791-47913.1313.19
44831-48313.1573.21
54837-48373.1613.21
64660-46603.0463.09
20min15071-50713.3143.382.053.393.472.14
25380-53803.5163.61
35152-51523.3673.46
45161-51613.3733.46
55129-51293.3523.44
65155-51553.3693.45
30min15704-57043.7283.622.013.853.742.00
25625-56253.6763.81
35554-55543.6303.76
45480-54803.5823.71
55432-54323.5503.67
65429-54293.5483.67
45min16090-60903.9803.812.484.143.972.39
25853-58533.8254.00
35839-58393.8163.99
45718-57183.7373.90
55692-56923.7203.88
65767-57673.7693.93
60min15858-58583.8293.831.534.034.031.65
25959-59593.8954.11
35902-59023.8574.07
45903-59033.8584.07
55785-57853.7813.98
65714-57143.7353.93
极限15902-59023.8573.842.034.104.091.94
25887-58873.8484.11
35966-59663.8994.15
45885-58853.8464.10
55948-59483.8884.13
65638-56383.6853.93
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