达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.601035941036281034391037991031261035170.25
212.661041991039641040820.16
单位质量响应值RSD%判断
8215.638221.330.05数据可信
供试品溶液-1批-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%
5min180859-8085979.10378.042.4479.1078.042.44
278313-7831376.61276.61
381454-8145479.68579.69
482169-8216980.38580.38
578094-7809476.39876.40
677728-7772876.04076.04
10min190447-9044788.48387.351.4988.6087.471.49
287523-8752385.62285.74
389619-8961987.67387.79
491023-9102389.04689.17
588773-8877386.84586.96
688340-8834086.42286.54
15min193910-9391091.87190.421.5692.1290.671.56
291225-9122589.24489.49
392318-9231890.31390.56
494228-9422892.18292.44
592294-9229490.29090.53
690589-9058988.62288.87
20min195693-9569393.61592.171.5094.0092.551.50
293183-9318391.15991.54
394145-9414592.10092.49
495791-9579193.71194.10
594322-9432292.27492.65
692162-9216290.16190.54
30min198016-9801695.88793.901.6696.4294.421.66
295510-9551093.43693.95
395478-9547893.40593.93
497157-9715795.04795.58
596320-9632094.22894.75
693425-9342591.39691.91
45min199143-9914396.99095.331.7097.6695.991.69
297660-9766095.53996.19
396650-9665094.55195.22
498426-9842696.28896.96
598239-9823996.10696.77
694543-9454392.49093.14
极限1101238-10123899.03998.341.7499.8699.141.73
2102208-10220899.988100.79
399780-9978097.61398.42
4100770-10077098.58299.40
5101723-10172399.514100.32
697389-9738995.27496.06
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.601042351039661040731039341040831040580.12
212.661037771040511039140.19
单位质量响应值RSD%判断
8258.578208.060.44数据可信
供试品溶液-1批-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%
5min184368-8436882.38879.182.9282.3979.182.92
279123-7912377.26677.27
380065-8006578.18678.19
483821-8382181.85481.85
579518-7951877.65277.65
679577-7957777.70977.71
10min191154-9115489.01588.411.9589.1488.531.95
289264-8926487.16987.28
390414-9041488.29288.41
493755-9375591.55591.68
589081-8908186.99087.11
689566-8956687.46487.58
15min193694-9369491.49591.701.9791.7591.951.97
293293-9329391.10391.35
394503-9450392.28592.53
497191-9719194.91095.17
591799-9179989.64489.89
692924-9292490.74390.99
20min195151-9515192.91893.382.2393.3193.772.22
295140-9514092.90793.29
397006-9700694.72995.12
499092-9909296.76697.17
593155-9315590.96991.35
694193-9419391.98292.37
30min196133-9613393.87795.112.2394.4195.642.22
296895-9689594.62195.14
399300-9930096.96997.50
4100796-10079698.43098.98
595493-9549393.25293.77
695743-9574393.49694.02
45min197298-9729895.01496.392.3295.6997.062.31
298313-9831396.00696.67
3100774-10077498.40999.08
4102206-10220699.807100.50
596526-9652694.26194.92
697100-9710094.82195.48
极限198851-9885196.53198.252.0297.3599.062.02
2101040-10104098.66999.48
3101560-10156099.176100.00
4104033-104033101.591102.44
599103-9910396.77797.58
699053-9905396.72897.53
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