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%
1 12.2699837998869995799003100102997570.44
212.33100565997431001540.59
单位质量响应值RSD%判断
8136.798122.790.13数据可信
供试品溶液-STGC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%
5min187274-8727486.31086.763.7886.3186.763.79
289718-8971888.72788.73
391445-9144590.43590.44
489551-8955188.56288.56
582110-8211081.20381.20
686294-8629485.34185.34
10min196787-9678795.71897.122.6895.8597.252.68
298012-9801296.93097.06
3102483-102483101.351101.49
494547-9454793.50393.64
598259-9825997.17497.30
699144-9914498.04998.18
15min196612-9661295.54597.402.5595.8297.682.54
299126-9912698.03198.31
3101954-101954100.828101.12
494721-9472193.67593.95
599359-9935998.26298.53
699169-9916998.07498.35
20min197026-9702695.95497.782.1796.3798.202.18
298176-9817697.09297.52
3102762-102762101.627102.07
497038-9703895.96696.38
598604-9860497.51597.93
699603-9960398.50398.93
30min195972-9597294.91297.052.2495.4797.622.24
298784-9878497.69398.26
3101245-101245100.127100.72
495222-9522294.17094.73
598909-9890997.81798.38
698683-9868397.59398.16
45min196467-9646795.40297.342.8196.1098.062.81
298007-9800796.92597.64
3103054-103054101.916102.66
495014-9501493.96594.66
598547-9854797.45998.17
699499-9949998.40099.12
极限195484-9548494.43096.672.3195.2897.532.31
298840-9884097.74898.61
3100509-10050999.399100.29
494567-9456793.52394.36
598383-9838397.29698.15
698721-9872197.63198.49
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%
1 12.26101138100830100492996731004041005070.55
212.339962098976992980.46
单位质量响应值RSD%判断
8197.968053.371.26数据可信
供试品溶液-STLH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%
5min182806-8280681.94083.472.9481.9483.472.94
283320-8332082.44882.45
383923-8392383.04583.04
481387-8138780.53580.54
587656-8765686.73986.74
687042-8704286.13186.13
10min188697-8869787.76989.573.2887.8989.693.28
287958-8795887.03887.16
389645-8964588.70788.83
489196-8919688.26388.38
591542-9154290.58490.71
696042-9604295.03795.17
15min189144-8914488.21190.462.2588.4790.722.25
289921-8992188.98089.23
390740-9074089.79090.05
490950-9095089.99890.25
593178-9317892.20392.47
694549-9454993.56093.83
20min190165-9016589.22291.363.2489.6191.753.24
289754-8975488.81589.20
391578-9157890.62091.01
491275-9127590.32090.71
593314-9331492.33892.74
697857-9785796.83397.25
30min191040-9104090.08792.082.8290.6192.622.82
291527-9152790.56991.09
391266-9126690.31190.84
492568-9256891.59992.12
594048-9404893.06493.61
697903-9790396.87997.44
45min192098-9209891.13492.832.9891.7993.502.98
291385-9138590.42991.09
392631-9263191.66292.33
492819-9281991.84892.51
594984-9498493.99094.67
698954-9895497.91998.62
极限196774-9677495.76196.891.5896.5597.701.59
296806-9680695.79396.59
396588-9658895.57796.38
498394-9839497.36498.16
598322-9832297.29398.12
6100600-10060099.547100.40
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%
1 12.2699440100435998411007341001881001280.51
212.339984899519996840.24
单位质量响应值RSD%判断
8167.058084.670.72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%
5min193536-9353692.55088.816.3692.5588.816.36
292427-9242791.45391.45
380299-8029979.45379.45
493773-9377392.78592.78
585064-8506484.16784.17
693459-9345992.47492.47
10min1102272-102272101.19498.781.60101.3398.911.60
298692-9869297.65297.79
398511-9851197.47397.59
4100603-10060399.54399.68
5100631-10063199.57099.70
698264-9826497.22897.37
15min1101227-101227100.16099.161.39100.4599.441.39
299414-9941498.36698.65
398247-9824797.21197.48
4102082-102082101.006101.29
5100730-10073099.66899.94
699611-9961198.56198.85
20min1101342-101342100.27499.021.41100.7199.451.41
299080-9908098.03698.47
398585-9858597.54697.96
4101559-101559100.488100.93
5101130-101130100.064100.49
698745-9874597.70498.14
30min1101323-101323100.25599.231.49100.8599.811.49
299799-9979998.74799.33
398397-9839797.36097.92
4102547-102547101.466102.06
5100367-10036799.30999.88
699269-9926998.22398.80
45min1100914-10091499.85099.251.13100.5999.981.14
298990-9899097.94798.67
398798-9879897.75798.46
4101514-101514100.444101.19
5100681-10068199.620100.34
6100945-10094599.881100.61
极限1100778-10077899.71698.541.36100.6199.411.36
299129-9912998.08498.96
397771-9777196.74097.59
4101379-101379100.310101.20
599809-9980998.75799.63
698643-9864397.60398.48
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