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%
112.261965591965421966281967501962921965540.09
212.331971441972931972180.06
单位质量响应值RSD%判断
16032.1415994.970.17数据可信
供试品溶液-25032601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%
5min1196933-19693398.87598.830.5998.8898.840.59
2197909-19790999.36599.37
3197892-19789299.35799.36
4195844-19584498.32898.33
5197414-19741499.11799.12
6195125-19512597.96797.97
10min1203141-203141101.992101.981.06102.14102.121.05
2203989-203989102.418102.57
3204458-204458102.653102.80
4205262-205262103.057103.20
5202622-202622101.732101.88
6199191-199191100.009100.16
15min1204295-204295102.571102.681.11102.87102.981.11
2204579-204579102.714103.02
3206088-206088103.472103.77
4206626-206626103.742104.04
5205218-205218103.035103.34
6200282-200282100.557100.85
20min1204619-204619102.734102.690.98103.19103.140.98
2204471-204471102.660103.12
3205107-205107102.979103.44
4206464-206464103.660104.12
5205758-205758103.306103.76
6200722-200722100.778101.23
30min1204497-204497102.673102.790.96103.28103.400.96
2204689-204689102.769103.38
3205045-205045102.948103.56
4207066-207066103.963104.58
5205862-205862103.358103.97
6201231-201231101.033101.63
45min1205081-205081102.966103.090.93103.73103.850.93
2205188-205188103.020103.78
3205393-205393103.123103.89
4207616-207616104.239105.01
5206675-206675103.766104.53
6202008-202008101.423102.17
60min1204525-204525102.687102.860.79103.60103.780.79
2205049-205049102.950103.87
3204854-204854102.852103.77
4206878-206878103.868104.79
5205879-205879103.367104.29
6202080-202080101.459102.36
极限1203753-203753102.299102.700.78103.37103.770.77
2204632-204632102.741103.81
3204283-204283102.565103.64
4206797-206797103.828104.91
5205621-205621103.237104.31
6202206-202206101.523102.58
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%
112.261967901964111969221964781967031966610.11
212.331974091978641976360.17
单位质量响应值RSD%判断
16040.8616028.870.06数据可信
供试品溶液-25032602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%
5min1197853-19785399.20598.811.4599.2098.811.45
2201561-201561101.064101.06
3196998-19699898.77698.78
4195744-19574498.14798.15
5197461-19746199.00899.01
6192814-19281496.67896.68
10min1207678-207678104.131102.301.50104.28102.441.50
2206370-206370103.475103.63
3204192-204192102.383102.53
4203682-203682102.128102.27
5203352-203352101.962102.11
6198840-19884099.70099.84
15min1205472-205472103.025102.491.31103.33102.791.31
2207026-207026103.804104.11
3204484-204484102.530102.83
4206073-206073103.327103.63
5203857-203857102.215102.52
6199465-199465100.013100.31
20min1206198-206198103.389102.731.38103.85103.181.38
2207532-207532104.058104.52
3205057-205057102.817103.27
4206621-206621103.601104.06
5204184-204184102.379102.83
6199670-199670100.116100.56
30min1205986-205986103.283102.681.28103.90103.291.29
2207335-207335103.959104.58
3205058-205058102.818103.43
4206573-206573103.577104.19
5203589-203589102.081102.69
6200136-200136100.350100.94
45min1206663-206663103.622103.051.20104.39103.821.20
2207706-207706104.145104.92
3206063-206063103.322104.09
4207295-207295103.939104.71
5204194-204194102.384103.15
6201203-201203100.885101.63
60min1206968-206968103.775102.881.28104.70103.801.28
2207586-207586104.085105.02
3205295-205295102.936103.86
4206702-206702103.642104.56
5204060-204060102.317103.23
6200521-200521100.543101.44
极限1206500-206500103.541102.861.06104.62103.941.06
2207007-207007103.795104.88
3204970-204970102.773103.85
4206796-206796103.689104.77
5204278-204278102.426103.50
6201347-201347100.957102.00
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%
112.269811497967979059805198006980090.09
212.339824198111981760.10
单位质量响应值RSD%判断
7994.217962.370.29数据可信
供试品溶液-25032603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%
5min196792-9679297.54196.921.6297.5496.921.62
293385-9338594.10894.11
396747-9674797.49697.50
497813-9781398.57098.57
596829-9682997.57897.58
695514-9551496.25396.25
10min1100879-100879101.660101.421.08101.81101.571.08
298696-9869699.46099.60
3100823-100823101.603101.75
4102022-102022102.812102.96
5100851-100851101.631101.78
6100583-100583101.361101.51
15min1101420-101420102.205102.801.59102.50103.091.59
299693-99693100.465100.75
3101831-101831102.619102.92
4102838-102838103.634103.94
5101686-101686102.473102.77
6104570-104570105.379105.68
20min1101522-101522102.308102.810.88102.76103.260.87
2102029-102029102.819103.26
3103312-103312104.112104.56
4102818-102818103.614104.07
5101420-101420102.205102.66
6100999-100999101.781102.24
30min1101375-101375102.160102.241.35102.77102.851.34
299411-99411100.180100.78
3101805-101805102.593103.20
4103607-103607104.409105.02
5101615-101615102.401103.01
6100928-100928101.709102.32
45min1101649-101649102.436102.081.11103.19102.831.11
299426-99426100.195100.94
3101780-101780102.568103.33
4102789-102789103.584104.35
5101170-101170101.953102.71
6100942-100942101.723102.48
60min1101398-101398102.183101.861.18103.10102.771.18
299140-9914099.907100.80
3101104-101104101.886102.80
4102831-102831103.627104.55
5101213-101213101.996102.91
6100756-100756101.536102.45
极限1101357-101357102.141101.661.22103.21102.731.22
298688-9868899.452100.50
3101270-101270102.054103.12
4102403-102403103.195104.28
5100756-100756101.536102.60
6100822-100822101.602102.67
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