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400
标示量(mg)25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%
110.285638275638865638985640615641305639600.03
210.215635865632575634220.05
单位质量响应值RSD%判断
54859.9255183.350.42数据可信
供试品溶液-F56971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%
5min1322472-32247252.21564.989.8752.2264.989.87
2420803-42080368.13768.14
3400959-40095964.92464.92
4415292-41529267.24567.24
5424242-42424268.69468.69
6424196-42419668.68668.69
10min1463484-46348475.04883.575.1675.1383.685.17
2525915-52591585.15785.27
3537335-53733587.00687.11
4516914-51691483.69983.81
5525073-52507385.02185.14
6528040-52804085.50185.62
15min1513057-51305783.07588.983.8983.2989.233.90
2558098-55809890.36890.62
3576795-57679593.39593.65
4540371-54037187.49887.75
5554778-55477889.83090.09
6554145-55414589.72889.98
20min1540090-54009087.45291.563.1387.8091.953.14
2576224-57622493.30393.71
3590490-59049095.61396.02
4552286-55228689.42789.82
5566458-56645891.72292.13
6567082-56708291.82392.23
30min1568418-56841892.03994.032.2192.5494.582.21
2592738-59273895.97796.54
3598896-59889696.97497.54
4567329-56732991.86392.41
5579237-57923793.79194.35
6577507-57750793.51194.07
45min1595712-59571296.45895.791.8197.1196.501.80
2601394-60139497.37998.10
3604386-60438697.86398.59
4576761-57676193.39094.09
5587048-58704895.05695.77
6584300-58430094.61195.33
60min1599500-59950097.07296.431.6397.8897.291.62
2604802-60480297.93098.81
3605710-60571098.07798.97
4581295-58129594.12494.98
5593627-59362796.12196.99
6588167-58816795.23796.11
极限1603017-60301797.64198.821.1898.6199.841.19
2620033-620033100.397101.44
3614706-61470699.534100.59
4608631-60863198.55099.56
5601600-60160097.41298.45
6613690-61369099.370100.40
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400
标示量(mg)25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%
110.285649915644225646055645035639325644910.07
210.215650885651345651110.01
单位质量响应值RSD%判断
54911.5855348.780.57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%
5min1464004-46400474.98572.752.9774.9872.752.97
2441077-44107771.28071.28
3460626-46062674.43974.44
4443153-44315371.61571.62
5431509-43150969.73369.73
6460643-46064374.44274.44
10min1575003-57500392.92391.331.5593.0591.451.55
2554251-55425189.56989.69
3575027-57502792.92693.05
4558265-55826590.21890.34
5561089-56108990.67490.79
6567269-56726991.67391.80
15min1596888-59688896.45995.820.9096.7496.090.90
2585482-58548294.61694.88
3598650-59865096.74497.02
4587422-58742294.93095.20
5595144-59514496.17796.44
6593989-59398995.99196.27
20min1602967-60296797.44297.160.6297.8897.590.62
2598104-59810496.65697.08
3603168-60316897.47497.91
4595559-59555996.24596.67
5605569-60556997.86298.29
6601905-60190597.27097.71
30min1605792-60579297.89898.340.6298.5098.930.61
2611887-61188798.88399.47
3607811-60781198.22598.83
4603430-60343097.51798.10
5613429-61342999.13299.72
6608776-60877698.38098.98
45min1605142-60514297.79398.850.7698.5699.600.75
2618128-61812899.892100.64
3611712-61171298.85599.62
4609315-60931598.46899.22
5615506-61550699.468100.22
6610163-61016398.60599.37
60min1608590-60859098.35099.150.7599.28100.070.74
2621074-621074100.368101.29
3613320-61332099.115100.05
4611019-61101998.74399.66
5616505-61650599.629100.55
6610667-61066798.68699.61
极限1620037-620037100.200100.470.69101.29101.560.69
2630061-630061101.820102.91
3622041-622041100.524101.62
4618903-618903100.017101.10
5620364-620364100.253101.34
6618714-61871499.986101.08
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400
标示量(mg)25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%
110.285629375631615633735630665629565630990.04
210.215659505660535660020.02
单位质量响应值RSD%判断
54776.1755436.040.85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%
5min1400044-40004464.67867.434.3664.6867.444.36
2449013-44901372.59572.60
3416486-41648667.33667.34
4425093-42509368.72868.73
5402209-40220965.02865.03
6409623-40962366.22766.23
10min1536051-53605186.66788.192.1486.7888.302.14
2559956-55995690.53290.65
3545213-54521388.14988.26
4558564-55856490.30790.42
5531665-53166585.95886.07
6541225-54122587.50487.61
15min1568001-56800191.83393.101.8692.0993.361.86
2579524-57952493.69693.97
3577014-57701493.29093.55
4594770-59477096.16196.43
5566311-56631191.56091.81
6569334-56933492.04992.30
20min1575701-57570193.07894.661.9093.4895.081.90
2584691-58469194.53194.96
3588414-58841495.13395.55
4606020-60602097.98098.41
5580785-58078593.90094.30
6577347-57734793.34493.75
30min1580723-58072393.89096.482.0794.4597.062.06
2590862-59086295.52996.11
3612071-61207198.95899.53
4610846-61084698.76099.35
5594831-59483196.17196.73
6591285-59128595.59896.16
45min1584503-58450394.50197.111.6795.2297.841.67
2594912-59491296.18496.93
3605215-60521597.85098.59
4614003-61400399.270100.02
5601637-60163797.27197.99
6603392-60339297.55598.28
60min1586026-58602694.74797.541.6595.6298.431.65
2598137-59813796.70597.61
3607687-60768798.24999.15
4613927-61392799.258100.18
5604668-60466897.76198.64
6609230-60923098.49999.39
极限1623122-623122100.745100.520.70101.78101.580.68
2622300-622300100.612101.68
3620159-620159100.266101.33
4614064-61406499.280100.36
5626664-626664101.317102.36
6624030-624030100.892101.94
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400
标示量(mg)25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%
110.285646705647785647765647535648645647680.02
210.215669245667335668280.03
单位质量响应值RSD%判断
54938.5255516.940.75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%
5min1417991-41799167.43066.786.9167.4366.786.91
2370628-37062859.79059.79
3406066-40606665.50765.51
4449897-44989772.57772.58
5399835-39983564.50164.50
6439208-43920870.85370.85
10min1556537-55653789.78185.953.3989.8986.063.39
2510480-51048082.35182.45
3512868-51286882.73682.85
4543291-54329187.64487.76
5533038-53303885.99086.10
6540618-54061887.21387.33
15min1595068-59506895.99690.833.5496.2691.083.55
2542243-54224387.47587.71
3542862-54286287.57587.82
4562390-56239090.72590.99
5561781-56178190.62790.88
6573921-57392192.58592.85
20min1603546-60354697.36492.693.1897.7993.103.18
2555718-55571889.64890.03
3556424-55642489.76290.16
4568510-56851091.71292.13
5581714-58171493.84294.24
6581486-58148693.80594.22
30min1608063-60806398.09394.802.5298.6895.362.53
2572293-57229392.32292.85
3574288-57428892.64493.19
4577763-57776393.20593.78
5598113-59811396.48897.05
6595199-59519996.01896.59
45min1609038-60903898.25096.342.3099.0097.062.29
2590207-59020795.21295.90
3583218-58321894.08594.78
4581531-58153193.81394.54
5609638-60963898.34799.07
6609533-60953398.33099.06
60min1610423-61042398.47496.872.0999.3997.752.09
2592299-59229995.55096.39
3586703-58670394.64795.50
4588671-58867194.96495.85
5611946-61194698.71999.60
6612914-61291498.87599.77
极限1610723-61072398.52299.711.1299.60100.751.12
2610066-61006698.41699.42
3615496-61549699.292100.30
4624877-624877100.805101.85
5621977-621977100.337101.38
6625282-625282100.871101.93
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