非布司他片项目信息
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.554078082407763440702394065601406302040709150.17
210.724149844414670741482760.06
单位质量响应值RSD%判断
385868.72386966.040.21数据可信
供试品溶液-250603批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112650-126500.2940.3520.720.290.3521.39
220037-200370.4660.47
312925-129250.3010.30
417262-172620.4020.40
515556-155560.3620.36
612141-121410.2820.28
10min133652-336520.7830.8613.450.780.8613.64
247109-471091.0961.10
334807-348070.8100.81
436814-368140.8570.86
535217-352170.8190.82
635176-351760.8180.82
15min138576-385760.8980.974.620.900.984.61
243537-435371.0131.02
343327-433271.0081.01
440554-405540.9440.95
543023-430231.0011.00
641962-419620.9760.98
20min142109-421090.9801.012.840.981.012.98
242833-428330.9971.00
344960-449601.0461.05
442285-422850.9840.99
544794-447941.0421.05
643189-431891.0051.01
30min141604-416040.9681.0410.260.971.0510.34
253834-538341.2531.26
343605-436051.0151.02
441493-414930.9650.97
544244-442441.0291.03
644031-440311.0241.03
45min154872-548721.2771.0914.711.281.1014.59
242485-424850.9891.00
343168-431681.0041.01
441840-418400.9740.98
556336-563361.3111.32
641885-418850.9750.98
60min142215-422150.9821.027.010.991.037.05
242781-427810.9951.01
344388-443881.0331.04
441023-410230.9550.96
543747-437471.0181.03
649793-497931.1591.17
90min141053-410530.9550.952.980.970.963.20
240438-404380.9410.95
341849-418490.9740.98
439315-393150.9150.92
542740-427400.9941.01
640249-402490.9360.95
120min139802-398020.9261.0016.360.941.0115.96
238878-388780.9050.92
357249-572491.3321.34
439777-397770.9260.94
542050-420500.9780.99
640462-404620.9410.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限140524-405240.9430.954.160.960.964.38
238680-386800.9000.91
342706-427060.9941.01
439850-398500.9270.94
542672-426720.9931.01
639503-395030.9190.93
非布司他片项目信息
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.554129556413056241266464128138412590941281620.05
210.724135131413225241336920.05
单位质量响应值RSD%判断
391294.98385605.601.04数据可信
供试品溶液-250603批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118247-182470.4220.3434.270.420.3433.80
214461-144610.3350.33
35049-50490.1170.12
419190-191900.4440.44
515841-158410.3670.37
616426-164260.3800.38
10min137565-375650.8700.848.360.870.848.43
237070-370700.8580.86
330715-307150.7110.71
437740-377400.8740.87
536096-360960.8360.84
639615-396150.9170.92
15min143139-431390.9990.971.731.000.971.80
242385-423850.9810.98
341346-413460.9570.96
441161-411610.9530.95
542046-420460.9730.98
641809-418090.9680.97
20min143491-434911.0070.973.031.010.973.10
242836-428360.9921.00
340074-400740.9280.93
440791-407910.9440.95
541901-419010.9700.97
642062-420620.9740.98
30min142854-428540.9920.972.911.000.982.95
243406-434061.0051.01
340067-400670.9270.93
442018-420180.9730.98
542098-420980.9740.98
641034-410340.9500.96
45min141207-412070.9540.942.620.960.952.47
242243-422430.9780.98
339400-394000.9120.92
440673-406730.9410.95
539574-395740.9160.92
640925-409250.9470.95
60min142408-424080.9820.9710.930.990.9811.10
241283-412830.9560.96
337412-374120.8660.87
440003-400030.9260.93
550477-504771.1681.18
639302-393020.9100.92
90min139140-391400.9060.893.960.920.903.95
239778-397780.9210.93
335813-358130.8290.84
439323-393230.9100.92
538924-389240.9010.91
637283-372830.8630.87
120min140291-402910.9330.927.840.940.937.61
238522-385220.8920.90
345973-459731.0641.07
437670-376700.8720.88
538716-387160.8960.91
638020-380200.8800.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限139942-399420.9250.9514.650.940.9714.47
253427-534271.2371.25
337913-379130.8780.89
438828-388280.8990.91
538723-387230.8960.91
638327-383270.8870.90
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