依折麦布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DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.159743769748309751669754569757829751220.06
211.179715569716129715840.01
单位质量响应值RSD%判断
87454.8986981.560.39数据可信
供试品溶液-2024092721批-依折麦布-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%
5min150137-501375.1614.7721.265.164.7721.25
254892-548925.6505.65
356574-565745.8235.82
440169-401694.1354.13
530380-303803.1273.13
645882-458824.7234.72
10min173550-735507.5717.254.737.637.304.84
269747-697477.1797.24
373111-731117.5257.59
469991-699917.2047.25
564389-643896.6286.66
671590-715907.3697.42
15min175081-750817.7287.414.157.877.544.27
272307-723077.4437.59
373747-737477.5917.74
471637-716377.3747.50
566417-664176.8366.94
672671-726717.4807.61
20min176397-763977.8647.562.218.097.782.20
271562-715627.3667.59
373324-733247.5477.78
472657-726577.4797.69
573106-731067.5257.71
673805-738057.5977.81
30min175682-756827.7907.502.198.107.802.21
271753-717537.3867.69
372072-720727.4197.74
473477-734777.5637.85
571268-712687.3367.60
672768-727687.4907.79
45min173039-730397.5187.432.317.927.812.11
269693-696937.1747.56
370533-705337.2607.66
472278-722787.4407.81
573553-735537.5717.92
673722-737227.5887.97
60min171739-717397.3847.391.217.877.861.10
270299-702997.2367.70
371471-714717.3577.84
471965-719657.4087.87
572612-726127.4747.91
672636-726367.4777.95
极限177551-775517.9827.705.528.558.255.01
273280-732807.5438.09
371109-711097.3197.88
472735-727357.4878.03
581960-819608.4368.95
672311-723117.4438.00
依折麦布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100
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%
110.162546722545362543082542832544842544570.07
210.192536622538242537430.05
单位质量响应值RSD%判断
25044.9824901.180.41数据可信
供试品溶液-2024092721批-贝派度酸-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%
5min14643-46431.8541.6723.801.851.6723.69
25091-50912.0332.03
35151-51512.0572.06
43485-34851.3921.39
52618-26181.0451.05
64046-40461.6161.62
10min17459-74592.9782.854.563.002.874.68
27195-71952.8732.90
37381-73812.9472.97
47144-71442.8532.87
56533-65332.6092.62
67179-71792.8672.88
15min17855-78553.1373.025.613.193.075.65
27778-77783.1063.16
37644-76443.0523.11
47644-76443.0523.10
56707-67072.6782.72
67697-76973.0743.12
20min18185-81853.2683.142.153.363.222.15
27679-76793.0663.16
37851-78513.1353.22
47813-78133.1203.20
57833-78333.1283.20
67827-78273.1253.21
30min18244-82443.2923.172.703.423.292.77
28006-80063.1973.32
37890-78903.1513.27
48073-80733.2243.34
57679-76793.0663.17
67731-77313.0873.21
45min17857-78573.1373.121.163.303.281.11
27787-77873.1093.27
37663-76633.0603.22
47869-78693.1423.29
57782-77823.1073.25
67921-79213.1633.32
60min17662-76623.0603.080.783.263.270.80
27813-78133.1203.31
37719-77193.0823.28
47731-77313.0873.27
57643-76433.0523.23
67713-77133.0803.27
极限17398-73982.9543.158.263.183.387.56
27555-75553.0173.24
37607-76073.0383.27
47823-78233.1243.34
59185-91853.6683.88
67810-78103.1193.34
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