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%
112.391006971006671007451006861007421007070.04
212.311003471003021003240.04
单位质量响应值RSD%判断
8128.098149.800.19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%
5min169451-6945168.60769.754.2968.6169.744.29
268941-6894168.10368.10
374894-7489473.98473.98
471491-7149170.62270.62
566288-6628865.48265.48
672556-7255671.67471.67
10min184197-8419783.17485.683.7783.2885.793.77
284048-8404883.02683.13
386893-8689385.83785.95
491992-9199290.87490.98
584209-8420983.18583.28
689097-8909788.01488.12
15min188518-8851887.44289.663.2087.6789.893.21
288388-8838887.31487.54
390306-9030689.20889.45
495700-9570094.53794.78
588963-8896387.88288.10
692678-9267891.55291.79
20min190650-9065089.54891.602.9089.9191.972.90
290568-9056889.46789.82
391782-9178290.66691.04
497418-9741896.23496.62
591549-9154990.43690.79
694394-9439493.24793.62
30min192960-9296091.83094.022.4592.3294.532.45
293785-9378592.64593.14
393919-9391992.77793.29
499403-9940398.19598.72
594994-9499493.83994.33
696014-9601494.84795.36
45min194793-9479393.64195.992.2094.2796.632.20
296893-9689395.71596.35
395559-9555994.39795.05
4100910-10091099.683100.36
597767-9776796.57997.21
697082-9708295.90296.56
极限196230-9623095.06097.392.0395.8398.182.02
2100139-10013998.92299.70
396377-9637795.20696.00
4100787-10078799.562100.39
599982-9998298.76799.54
698039-9803996.84797.65
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%
112.391003361001761002421004031002691002850.09
212.311006671007681007180.08
单位质量响应值RSD%判断
8094.038181.800.77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%
5min169635-6963568.79968.652.9468.8068.652.94
270184-7018469.34269.34
368303-6830367.48367.48
471579-7157970.72070.72
566060-6606065.26765.27
671133-7113370.27970.28
10min181795-8179580.81385.133.7480.9285.233.74
286614-8661485.57485.68
389507-8950788.43388.53
489745-8974588.66888.77
583231-8323182.23282.33
686073-8607385.04085.15
15min186360-8636085.32389.162.7885.5589.392.78
290343-9034389.25989.49
391906-9190690.80391.04
493406-9340692.28592.52
588503-8850387.44187.66
690948-9094889.85690.09
20min188985-8898587.91791.042.1188.2791.402.12
292632-9263291.52091.89
392744-9274491.63192.00
494889-9488993.75094.13
591288-9128890.19290.54
692329-9232991.22191.59
30min192011-9201190.90793.561.8591.3994.061.85
296125-9612594.97195.47
393852-9385292.72593.23
496971-9697195.80796.33
594753-9475393.61694.10
694489-9448993.35593.86
45min197909-9790996.73496.070.9897.3596.710.97
298079-9807996.90297.55
395658-9565894.51095.16
497990-9799096.81497.48
596969-9696995.80596.43
696799-9679995.63796.28
极限197745-9774596.57297.880.9097.3498.660.91
298523-9852397.34098.13
399164-9916497.97498.76
4100337-10033799.13399.94
599037-9903797.84898.62
699603-9960398.40799.20
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%
112.392013492014382013682014782014172014100.03
212.312021872021402021640.02
单位质量响应值RSD%判断
16255.8516422.750.73数据可信
供试品溶液-2025041711批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130240-13024064.08863.296.4664.0963.306.45
2135362-13536266.60966.61
3136602-13660267.21967.22
4116110-11611057.13557.14
5120847-12084759.46659.47
6132584-13258465.24265.24
10min1151062-15106274.33474.255.0474.4374.355.04
2151907-15190774.75074.85
3158050-15805077.77377.87
4136466-13646667.15267.24
5151718-15171874.65774.75
6156171-15617176.84876.95
15min1162081-16208179.75679.543.8979.9679.753.89
2161335-16133579.38979.60
3167377-16737782.36382.58
4149609-14960973.61973.81
5164707-16470781.04981.25
6164782-16478281.08681.30
20min1168858-16885883.09183.011.9283.4283.341.93
2167195-16719582.27382.60
3173203-17320385.22985.57
4163479-16347980.44480.74
5169780-16978083.54583.87
6169690-16969083.50183.84
30min1177368-17736887.27986.391.5587.7386.841.56
2175626-17562686.42286.88
3179364-17936488.26188.73
4171324-17132484.30584.72
5175149-17514986.18786.64
6174562-17456285.89886.36
45min1185665-18566591.36289.412.0491.9489.982.04
2184228-18422890.65591.24
3184913-18491390.99291.59
4176819-17681987.00987.55
5179447-17944788.30288.88
6179071-17907188.11788.71
极限1200470-20047098.64797.281.5599.3798.001.55
2200041-20004198.43699.16
3200805-20080598.81299.55
4195975-19597596.43597.11
5194618-19461895.76796.48
6194298-19429895.61096.33
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%
112.392012112013622014782015912014092014100.07
212.312009452008582009020.04
单位质量响应值RSD%判断
16255.8516320.230.28数据可信
供试品溶液-2025041711批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1125798-12579862.09663.617.3362.1063.617.33
2135028-13502866.65266.65
3136368-13636867.31367.31
4135674-13567466.97166.97
5111667-11166755.12155.12
6128671-12867163.51463.51
10min1145334-14533471.73974.595.6771.8374.695.67
2154462-15446276.24576.34
3159445-15944578.70578.81
4157944-15794477.96478.06
5136856-13685667.55467.64
6152640-15264075.34575.44
15min1154481-15448176.25479.184.8076.4579.394.81
2163734-16373480.82281.04
3168466-16846683.15783.38
4165659-16565981.77281.99
5147989-14798973.05073.23
6162130-16213080.03080.24
20min1159790-15979078.87581.834.3979.1982.164.40
2169430-16943083.63383.97
3173968-17396885.87386.22
4169737-16973783.78584.12
5154378-15437876.20376.50
6167383-16738382.62382.95
30min1166423-16642382.14984.794.0482.5885.244.04
2176657-17665787.20187.66
3179754-17975488.72989.20
4173878-17387885.82986.29
5160913-16091379.42979.84
6173066-17306685.42885.88
45min1172717-17271785.25687.303.7085.8187.873.70
2182447-18244790.05990.65
3184287-18428790.96791.57
4178051-17805187.88988.48
5166465-16646582.17082.70
6177132-17713287.43588.02
极限1194184-19418495.85296.681.7196.5497.391.71
2199543-19954398.49899.22
3198472-19847297.96998.71
4190833-19083394.19894.92
5194204-19420495.86296.51
6197988-19798897.73098.44
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