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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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 10.155501535501655496195490245491655496250.10
2 10.205504835501935503380.04
单位质量响应值RSD%判断
54150.2553954.710.26数据可信
供试品溶液-2024053011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%
5min1400494-40049466.01166.467.8766.0166.467.87
2397846-39784665.57465.57
3454480-45448074.90974.91
4377475-37747562.21762.22
5422381-42238169.61869.62
6366702-36670260.44160.44
10min1550417-55041790.72289.312.5390.8389.422.53
2550678-55067890.76590.87
3552378-55237891.04591.17
4547515-54751590.24390.35
5531179-53117987.55187.67
6518895-51889585.52685.63
15min1585540-58554096.51194.612.8596.7794.872.85
2598579-59857998.66098.92
3573197-57319794.47694.75
4573189-57318994.47594.73
5555685-55568591.59091.85
6557765-55776591.93392.18
20min1601514-60151499.14496.633.2599.5797.043.25
2613598-613598101.135101.56
3585153-58515396.44796.88
4585398-58539896.48796.90
5564806-56480693.09393.51
6566976-56697693.45193.85
30min1613621-613621101.13998.513.34101.7399.093.34
2625825-625825103.151103.74
3599973-59997398.89099.48
4594318-59431897.95898.53
5577406-57740695.17095.74
6574946-57494694.76595.32
45min1616010-616010101.53399.763.50102.29100.503.50
2631848-631848104.144104.91
3620046-620046102.198102.96
4601159-60115999.08599.82
5584717-58471796.37597.10
6577713-57771395.22195.93
60min1615501-615501101.449100.123.50102.37101.033.49
2632430-632430104.239105.18
3625453-625453103.089104.02
4605584-60558499.815100.72
5586760-58676096.71297.60
6579073-57907395.44596.31
极限1616672-616672101.642102.431.38102.74103.511.39
2634989-634989104.661105.77
3626302-626302103.229104.33
4619163-619163102.053103.12
5609949-609949100.534101.58
6621707-621707102.472103.50
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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 10.155487435485035487025487665483805486190.04
2 10.205479025476135477580.04
单位质量响应值RSD%判断
54051.1353701.760.46数据可信
供试品溶液-2024053011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%
5min1415034-41503468.63164.276.0868.6364.276.09
2355963-35596358.86358.86
3392781-39278164.95264.95
4376333-37633362.23262.23
5376622-37662262.28062.28
6415364-41536468.68668.69
10min1542535-54253589.71585.973.9389.8386.083.93
2499945-49994582.67382.77
3508542-50854284.09484.20
4501460-50146082.92383.03
5520354-52035486.04886.15
6546394-54639490.35490.47
15min1566952-56695293.75390.803.4094.0291.053.40
2539701-53970189.24789.48
3532659-53265988.08288.33
4533363-53336388.19988.44
5544558-54455890.05090.30
6577199-57719995.44895.71
20min1575085-57508595.09892.553.3295.5292.963.32
2555483-55548391.85792.24
3541923-54192389.61490.01
4542719-54271989.74690.13
5554356-55435691.67092.07
6588596-58859697.33297.76
30min1583944-58394496.56394.883.0197.1495.443.01
2568929-56892994.08094.62
3572346-57234694.64595.19
4550547-55054791.04091.58
5565640-56564093.53694.09
6601149-60114999.40899.99
45min1591324-59132497.78395.483.3098.5296.203.30
2581651-58165196.18496.88
3560414-56041492.67293.37
4554853-55485391.75292.44
5571340-57134094.47995.18
6604971-604971100.040100.79
60min1596498-59649898.63996.113.4599.5496.983.45
2588803-58880397.36698.22
3562600-56260093.03393.89
4556415-55641592.01192.85
5574855-57485595.06095.92
6607905-607905100.525101.44
极限1625884-625884103.498101.891.39104.57102.921.41
2608557-608557100.633101.65
3612268-612268101.247102.26
4611373-611373101.099102.10
5610651-610651100.979102.00
6628076-628076103.861104.95
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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 10.155496195501845499705499255501485499690.05
2 10.205482535481685482100.02
单位质量响应值RSD%判断
54184.1453746.080.58数据可信
供试品溶液-2024053011批-pH6.7
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1463844-46384476.57771.124.2976.5871.124.30
2431337-43133771.21171.21
3437009-43700972.14772.15
4421495-42149569.58669.59
5411917-41191768.00568.00
6419292-41929269.22269.22
10min1590033-59003397.41092.692.7897.5492.812.78
2567642-56764293.71493.83
3557195-55719591.98992.11
4550945-55094590.95791.07
5547869-54786990.44990.56
6555009-55500991.62891.74
15min1610285-610285100.75497.522.13101.0497.802.13
2598576-59857698.82199.10
3594095-59409598.08198.35
4582782-58278296.21396.48
5581105-58110595.93696.20
6577457-57745795.33495.60
20min1622485-622485102.76899.472.05103.2399.902.05
2608487-608487100.457100.90
3605690-60569099.995100.43
4594711-59471198.18298.61
5594910-59491098.21598.64
6588608-58860897.17597.60
30min1626472-626472103.426101.381.31104.06101.981.32
2618886-618886102.174102.78
3616789-616789101.827102.43
4607267-607267100.255100.85
5605621-60562199.984100.57
6609520-609520100.627101.22
45min1629717-629717103.962102.021.22104.76102.781.23
2621613-621613102.624103.40
3619924-619924102.345103.12
4610952-610952100.864101.62
5609398-609398100.607101.36
6615945-615945101.688102.44
60min1630490-630490104.089102.141.16105.06103.081.17
2622009-622009102.689103.64
3620261-620261102.401103.34
4611894-611894101.019101.95
5611671-611671100.982101.90
6615793-615793101.663102.59
极限1632298-632298104.388102.551.20105.54103.661.21
2623466-623466102.930104.05
3626114-626114103.367104.48
4613090-613090101.217102.31
5614556-614556101.459102.55
6617517-617517101.948103.04
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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 10.155467695469365465055468935469885468180.04
2 10.205489815495555492680.08
单位质量响应值RSD%判断
53873.6953849.800.04数据可信
供试品溶液-2024053011批-pH6.9
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1428452-42845270.86969.916.2570.8769.916.25
2428760-42876070.92070.92
3417974-41797469.13669.14
4376246-37624662.23462.23
5457561-45756175.68475.68
6427044-42704470.63670.64
10min1559973-55997392.62390.293.5292.7490.413.52
2540273-54027389.36589.48
3543693-54369389.93190.05
4514910-51491085.17085.27
5571247-57124794.48894.61
6545237-54523790.18690.30
15min1586298-58629896.97895.422.9697.2595.692.97
2573253-57325394.82095.09
3577444-57744495.51395.78
4549011-54901190.81091.06
5600775-60077599.37299.66
6574637-57463795.04995.32
20min1595545-59554598.50797.462.6898.9497.892.69
2590198-59019897.62398.05
3593307-59330798.13798.56
4562867-56286793.10293.50
5610503-610503100.981101.43
6582987-58298796.43096.86
30min1605063-605063100.08299.632.61100.68100.222.62
2603199-60319999.773100.36
3613227-613227101.432102.02
4576875-57687595.41995.97
5621990-621990102.881103.50
6593718-59371898.20598.79
45min1610517-610517100.984100.802.17101.75101.552.18
2608412-608412100.635101.39
3620717-620717102.671103.43
4589785-58978597.55498.27
5626136-626136103.567104.36
6600713-60071399.362100.11
60min1611523-611523101.150101.251.65102.08102.181.66
2606764-606764100.363101.28
3622761-622761103.009103.94
4603112-60311299.759100.63
5626054-626054103.554104.52
6602628-60262899.679100.60
极限1613951-613951101.552102.741.66102.65103.831.66
2613901-613901101.543102.63
3634558-634558104.960106.06
4619246-619246102.428103.47
5633405-633405104.770105.90
6611611-611611101.165102.25
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