达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.374176151417727641727654173358417465741748410.05
212.364156644415673741566900.01
单位质量响应值RSD%判断
337497.25336301.780.26数据可信
供试品溶液-1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%
40min13745037341373961.1101.082.471.111.082.59
23575935876358181.0631.06
33497335160350661.0411.04
43601435972359931.0681.07
53673936303365211.0841.08
63741137102372561.1061.11
30min112941711293375129377338.40238.581.1338.4138.591.14
212793391279252127929637.97337.98
312879091289172128854038.24738.25
413102731310552131041238.89638.90
513141571312955131355638.99039.00
613134821313729131360638.99139.00
60min124082352409784240901071.50672.171.5171.7072.371.51
224083412408794240856871.49271.69
324591712470270246472073.15973.36
424797492482193248097173.64273.84
523854432386601238602270.82371.02
624393382439683243951072.41172.61
180min1382545838284913826974113.594115.881.55114.15116.441.55
2392078039217833921282116.394116.95
3390886839154683912168116.123116.69
4399222939902473991238118.470119.04
5384281138438213843316114.079114.63
6392628239299503928116116.596117.16
600min1-00.0000.00-1.121.141.44
2-00.0001.13
3-00.0001.14
4-00.0001.16
5-00.0001.12
6-00.0001.15
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.374217567421838742143194211975420740742139310.11
212.364243589424131042424500.04
单位质量响应值RSD%判断
340657.32343240.290.54数据可信
供试品溶液-1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%
40min13639036540364651.0661.052.391.071.042.55
23605435979360161.0531.05
33523535280352581.0311.03
43603235952359921.0531.05
53664936355365021.0671.07
63438534169342771.0021.00
30min112848291286637128573337.60138.081.7137.6138.081.71
212926271293444129303637.81437.82
312745171275483127500037.28737.29
413366831293507131509538.45938.46
513067991305945130637238.20438.21
613352291338290133676039.09339.10
60min124839752487897248593672.70071.261.3572.8971.451.34
224258122428978242739570.98871.18
324416642447932244479871.49771.69
424370362436137243658671.25771.45
524391082442617244086271.38271.58
623791312388718238392469.71769.92
180min1392893039303173929624114.920114.871.70115.48115.431.69
2388314738839143883530113.572114.12
3406258540544424058514118.689119.24
4387944138818583880650113.488114.04
5390989239078933908892114.314114.87
6390607239083953907234114.265114.81
600min1-00.0000.00-1.131.120.75
2-00.0001.12
3-00.0001.14
4-00.0001.12
5-00.0001.12
6-00.0001.12
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