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%
112.391003621004971004991002281004211004010.12
212.311008391007001007700.10
单位质量响应值RSD%判断
8103.398186.030.72数据可信
供试品溶液-STGY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%
5min179294-7929478.27774.345.0978.2874.345.09
274424-7442473.46973.47
378428-7842877.42277.42
477885-7788576.88676.89
570156-7015669.25669.26
671621-7162170.70270.70
10min190519-9051989.35889.194.2089.4789.304.20
290121-9012188.96589.07
394631-9463193.41793.53
493420-9342092.22192.34
583761-8376182.68682.79
689645-8964588.49588.60
15min192991-9299191.79893.463.9492.0593.713.94
293618-9361892.41792.66
399237-9923797.96498.22
496559-9655995.32095.57
588689-8868987.55187.78
696973-9697395.72995.97
20min195483-9548394.25895.363.4194.6595.753.41
294787-9478793.57193.95
3101596-101596100.292100.70
498195-9819596.93597.33
591993-9199390.81391.17
697545-9754596.29396.68
30min197264-9726496.01696.992.4996.5597.522.49
296661-9666195.42195.94
3101995-101995100.686101.24
4100285-10028598.99899.54
595435-9543594.21194.71
697861-9786196.60597.13
45min198158-9815896.89998.542.7897.5799.222.78
299772-9977298.49299.16
3104300-104300102.962103.67
4101839-101839100.532101.22
597320-9732096.07196.71
697562-9756296.31096.98
极限197481-9748196.23098.042.1697.0598.862.16
2100029-10002998.74699.56
3101417-101417100.116100.97
4102079-102079100.769101.61
597408-9740896.15896.94
697495-9749596.24497.06
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%
112.391000741002871001151001341002031001630.09
212.311009771010571010170.06
单位质量响应值RSD%判断
8084.188206.091.06数据可信
供试品溶液-STGY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%
5min173761-7376172.81370.324.5572.8170.324.55
272598-7259871.66571.66
365372-6537264.53264.53
472507-7250771.57571.58
573566-7356672.62072.62
669601-6960168.70668.71
10min191448-9144890.27385.253.3890.3885.363.38
286054-8605484.94885.06
383750-8375082.67482.77
487117-8711785.99786.10
586458-8645885.34785.46
683330-8333082.25982.36
15min195161-9516193.93889.972.8594.1890.202.85
290926-9092689.75789.99
388590-8859087.45187.67
492291-9229191.10591.34
591764-9176490.58590.82
688112-8811286.98087.21
20min197537-9753796.28392.892.6896.6793.262.68
293038-9303891.84292.21
391720-9172090.54190.89
496444-9644495.20495.58
594461-9446193.24793.62
691380-9138090.20690.56
30min1100993-10099399.69596.102.28100.2296.612.28
295896-9589694.66395.17
394726-9472693.50994.00
497528-9752896.27596.79
598520-9852097.25497.77
696457-9645795.21795.71
45min1101802-101802100.49497.791.87101.1798.441.87
299997-9999798.71299.36
396849-9684995.60496.23
497707-9770796.45197.11
599995-9999598.71099.37
698011-9801196.75197.39
极限1101560-101560100.25598.291.52101.0899.091.52
299793-9979398.51099.31
399103-9910397.82998.60
497661-9766196.40697.21
5100964-10096499.666100.47
698329-9832997.06597.85
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