达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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%
1 12.312004412004022004402003832002452003820.05
212.272011772011052011410.03
单位质量响应值RSD%判断
16277.9916392.910.50数据可信
加速1月-供试品溶液-24111501批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1136014-13601466.94464.403.4966.9464.403.48
2127384-12738462.69762.70
3129150-12915063.56663.57
10min1129296-12929663.63862.773.1263.7462.873.12
2130331-13033164.14764.24
3122984-12298460.53160.63
15min1148477-14847773.07870.713.1973.2770.903.19
2139357-13935768.59068.78
3143168-14316870.46570.65
20min1150120-15012073.88772.513.0774.1972.813.06
2149749-14974973.70574.00
3142113-14211369.94670.24
30min1151464-15146474.54972.103.3074.9672.503.29
2141828-14182869.80670.21
3146177-14617771.94672.34
45min1153356-15335675.48074.702.6976.0175.212.67
2154811-15481176.19676.70
3147148-14714872.42472.93
60min1153774-15377475.68673.043.6676.3373.673.64
2142922-14292270.34470.97
3148505-14850573.09273.71
极限1155506-15550676.53875.842.7177.2976.582.69
2157375-15737577.45878.19
3149413-14941373.53974.26
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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%
1 12.312012472013662007892007402004942009270.19
212.272019972018772019370.05
单位质量响应值RSD%判断
16322.2616457.780.59数据可信
加速1月-供试品溶液-24111501批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1153239-15323975.17273.394.1475.1773.394.14
2153127-15312775.11775.12
3142474-14247469.89169.89
10min1147475-14747572.34469.713.3172.4669.833.31
2140139-14013968.74568.86
3138731-13873168.05568.16
15min1174349-17434985.52784.711.7385.7584.931.74
2174463-17446385.58385.80
3169236-16923683.01983.23
20min1167319-16731982.07880.152.1282.4380.492.12
2160830-16083078.89579.24
3162005-16200579.47279.80
30min1177948-17794887.29386.501.4987.7786.961.49
2177728-17772887.18587.65
3173315-17331585.02085.47
45min1169764-16976483.27881.791.6183.8882.381.61
2164671-16467180.77981.37
3165781-16578181.32481.90
60min1179331-17933187.97187.171.3488.7087.881.34
2178774-17877487.69888.41
3174977-17497785.83586.54
极限1170793-17079383.78382.401.6384.6483.241.62
2165352-16535281.11481.96
3167763-16776382.29683.13
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