氨氯地平阿托伐他汀钙片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.919428594219942989408594291942360.10
214.919484694699947720.11
单位质量响应值RSD%判断
6320.326356.270.41数据可信
供试品溶液-25091001批-氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min144702-4470261.76159.587.0161.7659.587.01
239598-3959854.70954.71
341345-4134557.12357.12
440732-4073256.27656.28
544908-4490862.04562.05
647447-4744765.55365.55
10min164666-6466689.34392.355.1889.4592.455.18
267170-6717092.80392.89
362997-6299787.03787.13
466499-6649991.87691.97
566562-6656291.96392.07
673165-73165101.086101.19
15min169173-6917395.57097.434.4195.8297.694.41
271780-7178099.17299.42
366666-6666692.10792.35
469724-6972496.33296.58
569883-6988396.55196.81
675908-75908104.875105.15
20min170748-7074897.746100.353.9998.16100.773.99
272788-72788100.565100.98
369133-6913395.51595.91
472733-72733100.489100.90
572657-72657100.384100.80
677731-77731107.394107.85
30min171534-7153498.832102.483.3899.41103.063.38
273430-73430101.452102.03
371734-7173499.10999.66
475456-75456104.251104.83
574701-74701103.208103.79
678171-78171108.002108.63
45min177451-77451107.007105.623.24107.75106.373.24
273766-73766101.916102.66
372963-72963100.807101.52
477265-77265106.750107.50
578300-78300108.180108.94
678919-78919109.035109.85
极限181138-81138112.101110.493.87113.02111.423.84
275514-75514104.331105.25
378715-78715108.754109.64
481472-81472112.563113.49
584504-84504116.752117.69
678473-78473108.419109.41
氨氯地平阿托伐他汀钙片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.653624183624963625013625183626723625210.03
2 11.563652483651753652120.02
单位质量响应值RSD%判断
31117.6831592.731.08数据可信
供试品溶液-25091001批-阿托伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1218802-21880238.90139.364.1938.9039.364.18
2219116-21911638.95738.96
3221312-22131239.34739.35
4212816-21281637.83737.84
5216771-21677138.54038.54
6239345-23934542.55442.55
10min1255083-25508345.35246.725.3345.4246.795.33
2272852-27285248.51148.58
3260332-26033246.28546.35
4253985-25398545.15645.22
5248615-24861544.20244.27
6285910-28591050.83250.90
15min1264704-26470447.06248.294.9847.2048.434.98
2281537-28153750.05550.20
3268503-26850347.73847.88
4263611-26361146.86847.01
5257397-25739745.76345.90
6293744-29374452.22552.38
20min1268011-26801147.65048.994.5047.8749.224.50
2284063-28406350.50450.73
3272575-27257548.46248.68
4270732-27073248.13448.35
5261945-26194546.57246.79
6296071-29607152.63952.88
30min1272566-27256648.46049.603.9548.7649.913.96
2285961-28596150.84151.15
3277504-27750449.33849.64
4274355-27435548.77849.07
5266365-26636547.35747.65
6297257-29725752.85053.18
45min1277554-27755449.34750.213.1449.7350.603.14
2286569-28656950.95051.35
3280982-28098249.95650.34
4279075-27907549.61750.00
5272393-27239348.42948.80
6297789-29778952.94453.36
极限1289185-28918551.41551.791.4851.8852.271.50
2289553-28955351.48051.96
3293696-29369652.21752.69
4288975-28897551.37751.84
5287535-28753551.12151.57
6298997-29899753.15953.67
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