恩格列净片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
110.331404407140432414043141404909140482414045560.03
210.281396166139475113954580.08
单位质量响应值RSD%判断
135968.64135744.940.12数据可信
供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024052511批包装高温1152622515266911526458100.1098.411.0997.30%~99.53%
214901291489784148995697.71
314824211480702148156297.16
415062821506234150625898.78
515081291508412150827098.91
614914581491456149145797.81
包装高湿114915781491918149174897.8297.941.8496.05%~99.82%
2153433015339601534145100.60
314589561459489145922295.69
414894371489145148929197.66
515141751515328151475299.33
614718631471985147192496.52
包装光照114881991489230148871497.6399.221.0098.18%~100.25%
2153036415313081530836100.39
315222361522681152245899.84
415118281512339151208499.16
515042831503301150379298.61
615200861519900151999399.68
恩格列净片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
110.331397278139612513978531398365139868113976600.08
210.281409562140949114095260.01
单位质量响应值RSD%判断
135301.06137113.420.95数据可信
供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024052511批包装高温114679601467740146785096.0197.731.0096.71%~98.76%
214963381495626149598297.85
315103701510251151031098.79
414975471496784149716697.93
515049871504798150489298.44
614888341488515148867497.38
包装高湿114626821463260146297195.6997.130.8696.25%~98.01%
214986861498037149836298.01
314916371492914149227697.61
414858521486101148597697.20
514781481478322147823596.69
614919541492052149200397.59
包装光照115002281500611150042098.1497.511.0296.47%~98.55%
215021701503241150270698.29
315033471503203150327598.33
414647851465831146530895.85
514800361481147148059296.85
614918451492473149215997.60
恩格列净片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
110.331395787139728313977291397639139732913971530.06
210.281400212140042114003160.02
单位质量响应值RSD%判断
135251.98136217.510.51数据可信
供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024052511批包装高温114832151482729148297297.3499.652.0697.51%~101.80%
2155749315567531557123102.20
314888181488571148869497.71
4155245615522931552374101.89
515106601509912151028699.13
615186211517404151801299.64
包装高湿115121471510755151145199.2199.820.6499.15%~100.48%
2153226215319071532084100.56
3152750115267451527123100.24
415154101514551151498099.44
5152851215289211528716100.34
615098841510104150999499.11
包装光照1154773815480951547916101.6099.991.1398.81%~101.17%
215215861521380152148399.87
314995341498937149923698.41
4152556815258681525718100.14
5153428115346531534467100.72
615114161511261151133899.20
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