恩格列净片项目信息
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100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%
1 10.065492425485775490425478905490085487520.10
2 10.005511675514275512970.04
单位质量响应值RSD%判断
54547.9155129.700.76数据可信
供试品溶液-2024052811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%
5min1574902-57490294.35492.441.1594.3592.441.15
2559370-55937091.80591.80
3564207-56420792.59992.60
4556221-55622191.28891.29
5560924-56092492.06092.06
6563765-56376592.52692.53
10min1617425-617425101.33399.531.36101.4999.681.36
2601377-60137798.69998.85
3602519-60251998.88799.04
4596481-59648197.89698.05
5615086-615086100.949101.10
6605689-60568999.40799.56
15min1622846-622846102.223100.721.20102.55101.041.20
2610708-610708100.231100.55
3608423-60842399.856100.17
4604894-60489499.27699.59
5622064-622064102.094102.42
6613326-613326100.660100.98
20min1624038-624038102.418101.001.16102.91101.481.16
2613805-613805100.739101.22
3610050-610050100.123100.61
4606281-60628199.50499.98
5623390-623390102.312102.80
6614703-614703100.886101.37
30min1628460-628460103.144101.421.33103.81102.081.33
2614630-614630100.874101.53
3613049-613049100.615101.27
4608188-60818899.817100.46
5627422-627422102.974103.64
6616065-616065101.110101.77
45min1628068-628068103.080101.641.26103.92102.461.25
2617352-617352101.321102.14
3614425-614425100.841101.66
4609216-60921699.986100.80
5628858-628858103.209104.04
6617704-617704101.379102.20
60min1626971-626971102.900101.631.15103.91102.621.15
2618054-618054101.436102.43
3614259-614259100.813101.80
4610162-610162100.141101.12
5628177-628177103.098104.10
6617810-617810101.396102.39
极限1625090-625090102.591101.481.17103.77102.641.17
2616728-616728101.219102.38
3614521-614521100.856102.01
4608897-60889799.933101.08
5628541-628541103.157104.34
6615975-615975101.095102.26
恩格列净片项目信息
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100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%
1 10.065489695498705498975504535505585499490.12
2 10.005478515479185478840.01
单位质量响应值RSD%判断
54666.9054788.400.16数据可信
供试品溶液-2024052811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%
5min1537022-53702288.31491.462.4288.3191.462.42
2544461-54446189.53789.54
3558820-55882091.89891.90
4568289-56828993.45693.46
5571732-57173294.02294.02
6556598-55659891.53391.53
10min1597878-59787898.32299.481.4998.4799.631.49
2600144-60014498.69498.84
3609674-609674100.261100.41
4608250-608250100.027100.18
5618783-618783101.759101.92
6594775-59477597.81197.96
15min1605641-60564199.598100.621.3199.91100.941.31
2609515-609515100.235100.55
3616004-616004101.302101.62
4614846-614846101.112101.43
5623786-623786102.582102.91
6601486-60148698.91599.23
20min1608934-608934100.140101.230.79100.62101.720.80
2611881-611881100.624101.11
3618161-618161101.657102.15
4616813-616813101.435101.93
5622746-622746102.411102.91
6614964-614964101.131101.61
30min1611504-611504100.562101.291.27101.21101.941.27
2613538-613538100.897101.55
3618759-618759101.755102.41
4618128-618128101.652102.31
5628300-628300103.324103.99
6605364-60536499.553100.20
45min1613408-613408100.875101.641.25101.69102.471.25
2615878-615878101.282102.10
3620422-620422102.029102.86
4620385-620385102.023102.85
5630509-630509103.688104.53
6607792-60779299.952100.77
60min1611965-611965100.638101.932.04101.62102.932.03
2615611-615611101.238102.22
3619494-619494101.876102.87
4620473-620473102.037103.04
5643750-643750105.865106.88
6607808-60780899.955100.94
极限1613309-613309100.859101.441.30102.01102.601.30
2614412-614412101.041102.19
3618669-618669101.741102.91
4618878-618878101.775102.94
5629884-629884103.585104.77
6605769-60576999.619100.77
恩格列净片项目信息
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100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%
1 10.065485905490065489595484755483185486700.06
2 10.005517775522245520000.06
单位质量响应值RSD%判断
54539.7655200.000.86数据可信
供试品溶液-2024052911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%
5min1549146-54914690.07787.692.6390.0887.692.63
2549879-54987990.19790.20
3536009-53600987.92287.92
4535972-53597287.91687.92
5516301-51630184.68984.69
6520357-52035785.35485.35
10min1602672-60267298.85697.711.1099.0197.861.10
2599367-59936798.31498.46
3597061-59706197.93698.08
4587002-58700296.28696.43
5588238-58823896.48996.63
6599728-59972898.37498.52
15min1612224-612224100.42399.321.13100.7499.631.13
2609708-609708100.011100.32
3605924-60592499.39099.70
4594785-59478597.56397.87
5599975-59997598.41498.72
6610345-610345100.115100.42
20min1615013-615013100.88199.741.19101.36100.211.19
2611819-611819100.357100.84
3609303-60930399.944100.42
4596085-59608597.77698.25
5602948-60294898.90299.37
6613114-613114100.569101.04
30min1615927-615927101.031100.031.17101.68100.671.17
2613778-613778100.678101.33
3610021-610021100.062100.70
4597846-59784698.06598.70
5605350-60535099.29699.93
6615971-615971101.038101.68
45min1621308-621308101.913100.321.43102.73101.131.42
2615699-615699100.993101.81
3610306-610306100.109100.92
4597438-59743897.99898.79
5606885-60688599.548100.34
6618067-618067101.382102.19
60min1615449-615449100.952100.231.39101.94101.211.39
2616012-616012101.045102.03
3613125-613125100.571101.55
4594926-59492697.58698.55
5608911-60891199.880100.84
6617907-617907101.356102.33
极限1615057-615057100.888100.131.24102.04101.271.24
2615056-615056100.888102.04
3611520-611520100.308101.45
4596781-59678197.89099.01
5607223-60722399.603100.73
6617050-617050101.215102.36
恩格列净片项目信息
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101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100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%
1 10.065499375485235497375482525495475491990.14
2 10.005541075537075539070.06
单位质量响应值RSD%判断
54592.3555390.701.03数据可信
供试品溶液-2024052911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%
5min1554003-55400390.67487.643.5090.6787.643.51
2545771-54577189.32689.33
3539056-53905688.22788.23
4524313-52431385.81485.81
5503176-50317682.35582.35
6546621-54662189.46689.47
10min1602597-60259798.62796.771.7498.7896.921.74
2580594-58059495.02695.17
3598056-59805697.88498.03
4594753-59475397.34397.49
5576679-57667994.38594.52
6594900-59490097.36797.52
15min1608964-60896499.66998.191.6399.9898.501.63
2588733-58873396.35896.67
3607562-60756299.44099.75
4605362-60536299.08099.38
5586641-58664196.01696.31
6602459-60245998.60598.92
20min1611441-611441100.07598.681.65100.5699.151.65
2590133-59013396.58797.06
3611100-611100100.019100.49
4607839-60783999.48599.96
5590476-59047696.64397.10
6606431-60643199.25599.73
30min1615447-615447100.73098.991.75101.3899.631.74
2590746-59074696.68897.32
3612990-612990100.328100.97
4609827-60982799.811100.45
5592760-59276097.01797.63
6607188-60718899.379100.02
45min1615208-615208100.69199.321.85101.51100.121.85
2591317-59131796.78197.57
3615189-615189100.688101.50
4611539-611539100.091100.89
5593619-59361997.15897.94
6614028-614028100.498101.30
60min1614476-614476100.57199.561.38101.56100.531.38
2602138-60213898.55299.50
3615414-615414100.725101.70
4611908-611908100.151101.12
5594261-59426197.26398.20
6611759-611759100.127101.10
极限1615892-615892100.80399.401.73101.95100.531.73
2594576-59457697.31498.43
3614562-614562100.585101.73
4616120-616120100.840101.98
5593869-59386997.19998.30
6608828-60882899.647100.79
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