恩格列净片项目信息
介质体积(ml)900取样体积(ml)10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%
110.115660525660065662705659415662335661000.03
210.045656735651165653940.07
单位质量响应值RSD%判断
55994.0756314.140.41数据可信
影响因素30天-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
2024053011高温160796560807760802196.4796.490.6495.85%～97.14%
261458661468161463497.52
360777260753960765696.41
460366360380460373495.79
561008160978660993496.77
660503160512860508096.00
2024053011高湿162032762065762049298.4498.841.0997.71%～99.96%
2631219630927631073100.12
362926362853062889699.78
461306561301261303897.26
562498162551862525099.20
661923961879061901498.21
2024053011光照161752761730461741697.9697.662.0495.57%～99.74%
2631706632086631896100.25
361108561123961116296.96
459962359994159978295.16
562734862763462749199.56
660544160532760538496.05
恩格列净片项目信息
介质体积(ml)900取样体积(ml)10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%
110.115673545669825671875668485668455670430.04
210.045653935656105655020.03
单位质量响应值RSD%判断
56087.3456324.900.30数据可信
影响因素30天-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
2024053011高温160503160512360507795.9196.380.3995.99%～96.78%
261069561059761064696.79
361111461128361119896.88
460703760735060719496.25
560746760752660749696.29
660693360662360677896.18
2024053011高湿161756561784761770697.9197.371.5495.80%～98.94%
261948961924061936498.17
362174262154762164498.54
459622459666959644694.54
561121561131561126596.89
661958461915161936898.18
2024053011光照161068761060061064496.7996.741.4295.30%～98.18%
260955660990460973096.65
362347862305562326698.79
459765959784959775494.75
561535961498261517097.51
660513460559060536295.95
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