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%
114.038320383517831338334883289832980.18
214.068325683263832600.01
单位质量响应值RSD%判断
5937.135921.760.19数据可信
加速6月-供试品溶液-X003810批-西格列汀-0.025mol/L氯化钠溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min116171-1617119.05020.5116.0419.0520.5116.04
220580-2058024.24424.24
313074-1307415.40115.40
416283-1628319.18219.18
519899-1989923.44123.44
618469-1846921.75721.76
10min136331-3633142.79946.849.8142.8346.889.82
243637-4363751.40551.45
334333-3433340.44540.47
439522-3952246.55846.59
544116-4411651.97052.01
640636-4063647.87047.91
15min153860-5386063.44868.037.1563.5568.147.15
261165-6116572.05472.18
352450-5245061.78761.88
457034-5703467.18767.30
563072-6307274.30074.43
658891-5889169.37569.49
20min166536-6653678.38181.764.4478.5981.984.45
271159-7115983.82784.07
365423-6542377.07077.27
468703-6870380.93481.16
573536-7353686.62786.88
671050-7105083.69983.93
30min176674-7667490.32492.972.0790.6693.332.08
279852-7985294.06894.45
377946-7794691.82292.15
477952-7795291.82992.19
580251-8025194.53894.93
680834-8083495.22495.60
45min181665-8166596.20396.700.6496.6997.220.67
282684-8268497.40497.95
381889-8188996.46796.94
481376-8137695.86396.37
582542-8254297.23697.79
682373-8237397.03797.57
60min182583-8258397.28596.980.5397.9497.650.54
282697-8269797.41998.12
381605-8160596.13396.77
482015-8201596.61697.28
582628-8262897.33898.05
682400-8240097.06997.76
极限182468-8246897.14997.030.3797.9697.870.39
282765-8276597.49998.37
382060-8206096.66997.47
481957-8195796.54797.38
582458-8245897.13798.01
682473-8247397.15598.01
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10
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%
19.593663762366444436524893653496365044436569270.19
29.623683004367825736806300.10
单位质量响应值RSD%判断
381327.11382601.870.24数据可信
加速6月-供试品溶液-X003810批-二甲双胍-0.025mol/L氯化钠溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1944163-94416326.14727.6613.9426.1527.6613.93
21155285-115528531.99331.99
3778900-77890021.57021.57
4945616-94561626.18726.19
51126401-112640131.19331.19
61041791-104179128.85028.85
10min11842604-184260451.02755.168.2051.0755.208.21
22155876-215587659.70259.76
31769465-176946549.00149.04
41977200-197720054.75454.80
52172926-217292660.17460.23
62032492-203249256.28556.33
15min12528551-252855170.02374.405.6770.1574.545.68
22812071-281207177.87478.03
32499358-249935869.21469.33
42657470-265747073.59373.73
52875290-287529079.62579.78
62746721-274672176.06476.21
20min12986747-298674782.71186.033.6482.9686.293.65
23170029-317002987.78788.07
32976591-297659182.43082.66
43077924-307792485.23685.49
53262165-326216590.33990.62
63165840-316584087.67187.94
30min13342013-334201392.55094.981.6992.9395.391.71
23460363-346036395.82796.26
33402770-340277094.23294.60
43400448-340044894.16894.57
53479367-347936796.35496.79
63493864-349386496.75597.17
45min13495412-349541296.79897.680.6497.3498.240.65
23549086-354908698.28498.87
33532348-353234897.82198.35
43504129-350412997.03997.60
53547218-354721898.23298.83
63534342-353434297.87698.45
60min13519857-351985797.47597.780.3898.1798.500.41
23540988-354098898.06098.81
33524965-352496597.61698.31
43515092-351509297.34398.06
53550475-355047598.32399.08
63532961-353296197.83898.58
极限13506005-350600597.09197.770.4697.9598.660.48
23538946-353894698.00398.92
33526416-352641697.65698.51
43520668-352066897.49798.38
53550380-355038098.32099.24
63540178-354017898.03898.94
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