西格列汀二甲双胍片项目信息
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DSTP-202308101B对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.28对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.228239482319819638212482330822260.22
2 14.218224482127821860.11
单位质量响应值RSD%判断
5782.425783.670.02数据可信
加速6月-供试品溶液-2024050721批-西格列汀-0.025molNACL
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113605-1360516.43315.6613.5516.4315.6613.56
216009-1600919.33619.34
311450-1145013.83013.83
411784-1178414.23314.23
513336-1333616.10816.11
611586-1158613.99413.99
10min139271-3927147.43345.964.3547.4645.984.36
240546-4054648.97349.01
336350-3635043.90543.93
438265-3826546.21846.24
536427-3642743.99844.02
637439-3743945.22045.24
15min160093-6009372.58369.632.6172.6969.732.61
258551-5855170.72070.83
357367-5736769.29069.39
456773-5677368.57368.67
555766-5576667.35767.46
657344-5734469.26369.36
20min172223-7222387.23483.422.8787.4683.642.87
269466-6946683.90484.14
368133-6813382.29482.51
466805-6680580.69080.91
567583-6758381.63081.84
670202-7020284.79385.01
30min178119-7811994.35694.031.6394.7394.391.63
278276-7827694.54594.92
376394-7639492.27292.62
476755-7675592.70893.06
577615-7761593.74794.10
679951-7995196.56896.92
45min179848-7984896.44496.670.5596.9797.190.54
279502-7950296.02696.56
379704-7970496.27096.77
480138-8013896.79497.30
580635-8063597.39597.90
680406-8040697.11897.63
60min180056-8005696.69596.950.5897.3997.630.58
280549-8054997.29197.98
380017-8001796.64897.31
480620-8062097.37698.04
580804-8080497.59998.27
679573-7957396.11296.79
极限179894-7989496.49996.550.7097.3597.390.69
279295-7929595.77696.63
379981-7998196.60597.43
480473-8047397.19998.03
580640-8064097.40198.23
679349-7934995.84196.68
西格列汀二甲双胍片项目信息
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DA-1142209074对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)850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%
119.004279511427999342793914282246428395642810190.05
219.024281392427168342765380.17
单位质量响应值RSD%判断
225316.79224844.270.15数据可信
加速6月-供试品溶液-2024050721批-二甲双胍-0.025molNACL
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11065445-106544525.03523.4911.5725.0423.5011.57
21190622-119062227.97727.98
3907203-90720321.31721.32
4924831-92483121.73121.73
51018631-101863123.93523.94
6892426-89242620.97020.97
10min12482675-248267558.33756.534.2058.3856.564.20
22560413-256041360.16360.21
32312454-231245454.33754.37
42408806-240880656.60156.64
52301008-230100854.06854.11
62368164-236816455.64655.68
15min13455623-345562381.19878.562.1981.3478.692.19
23403751-340375179.98080.13
33322429-332242978.06978.19
43303813-330381377.63177.76
53255584-325558476.49876.63
63317714-331771477.95878.09
20min13981410-398141093.55390.322.3093.8390.582.30
23900073-390007391.64291.92
33789502-378950289.04489.30
43745809-374580988.01788.28
53781022-378102288.84589.10
63863756-386375690.78991.05
30min14211736-421173698.96598.611.2399.4099.021.24
24257141-4257141100.032100.47
34134398-413439897.14897.55
44142467-414246797.33897.74
54186450-418645098.37198.78
64246685-424668599.786100.20
45min14266726-4266726100.257100.450.46100.85101.020.46
24285088-4285088100.689101.29
34276540-4276540100.488101.05
44257322-4257322100.036100.61
54307278-4307278101.210101.78
64255452-425545299.992100.57
60min14269708-4269708100.327100.400.96101.09101.150.96
24328493-4328493101.709102.48
34258871-4258871100.073100.81
44269749-4269749100.328101.06
54302056-4302056101.088101.83
64208506-420850698.88999.63
极限14257020-4257020100.029100.090.62100.96101.000.61
24274712-4274712100.445101.38
34267211-4267211100.269101.17
44255700-425570099.998100.90
54289528-4289528100.793101.70
64212878-421287898.99299.90
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