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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.361962041977671974941971801972531971800.31
212.451981331972801977060.31
单位质量响应值RSD%判断
15953.0715880.000.33数据可信
供试品溶液-24123101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%
5min1157750-15775079.92279.602.6079.9279.602.60
2161691-16169181.91881.92
3156769-15676979.42579.42
4153302-15330277.66877.67
5161409-16140981.77681.78
6151737-15173776.87576.88
10min1172591-17259187.44187.500.7587.5687.620.75
2172349-17234987.31887.44
3172658-17265887.47587.59
4171769-17176987.02487.14
5175198-17519888.76288.88
6171679-17167986.97987.09
15min1172790-17279087.54289.271.1187.7989.521.11
2177400-17740089.87790.13
3176003-17600389.16989.42
4178483-17848390.42690.67
5176805-17680589.57689.83
6175731-17573189.03289.28
20min1175144-17514488.73489.980.7389.1290.360.73
2177761-17776190.06090.45
3178551-17855190.46090.84
4178593-17859390.48290.86
5177330-17733089.84290.23
6178205-17820590.28590.66
30min1176001-17600189.16891.551.3689.6892.061.35
2181333-18133391.87092.39
3181911-18191192.16392.68
4180886-18088691.64392.16
5180903-18090391.65292.18
6183146-18314692.78893.30
45min1179223-17922390.80193.011.7991.4593.661.78
2182996-18299692.71293.37
3189261-18926195.88696.54
4183848-18384893.14493.80
5182201-18220192.30992.97
6183942-18394293.19293.85
60min1180016-18001691.20293.611.7691.9994.401.75
2184906-18490693.68094.48
3190089-19008996.30697.11
4183995-18399593.21894.01
5185533-18553393.99894.80
6184045-18404593.24494.04
极限1201345-201345102.009103.121.43102.93104.061.41
2203798-203798103.251104.19
3201130-201130101.900102.85
4205487-205487104.107105.04
5201223-201223101.947102.89
6208233-208233105.498106.43
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