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%
112.311980961975861980931980491977671979180.12
212.271987321994921991120.27
单位质量响应值RSD%判断
16077.8216227.550.66数据可信
供试品溶液-WA3063批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193370-9337046.47658.8727.4246.4858.8827.41
2141553-14155370.46070.46
385254-8525442.43642.44
4134502-13450266.95066.95
591645-9164545.61745.62
6163352-16335281.31081.31
10min1168649-16864983.94787.634.3084.0287.724.31
2180317-18031789.75589.86
3175898-17589887.55587.62
4169879-16987984.55984.66
5172690-17269085.95886.03
6188826-18882693.99094.11
15min1177926-17792688.56591.194.0988.7691.414.11
2185720-18572092.44492.68
3185704-18570492.43692.63
4175919-17591987.56687.79
5178043-17804388.62388.82
6195863-19586397.49397.76
20min1181522-18152290.35592.833.2290.6893.183.23
2187395-18739593.27893.66
3189182-18918294.16794.50
4183685-18368591.43191.79
5180522-18052289.85790.19
6196641-19664197.88098.29
30min1184080-18408091.62893.623.2892.0994.113.29
2190427-19042794.78795.31
3192558-19255895.84896.32
4181796-18179690.49190.99
5182653-18265390.91791.38
6196952-19695298.03598.59
45min1187471-18747193.31695.272.8593.9295.912.87
2196078-19607897.60098.26
3194649-19464996.88997.51
4185194-18519492.18292.81
5187030-18703093.09693.70
6197957-19795798.53599.24
60min1191578-19157895.36096.562.6596.1097.342.66
2198472-19847298.79299.60
3198265-19826598.68999.45
4187622-18762293.39194.16
5189176-18917694.16494.91
6198870-19887098.99099.84
极限1201628-201628100.363100.361.88101.25101.291.84
2201609-201609100.353101.31
3204618-204618101.851102.76
4196619-19661997.86998.78
5206843-206843102.958103.84
6198465-19846598.78899.79
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%
112.311985371988461985491983811992001987030.17
212.271971641983241977440.42
单位质量响应值RSD%判断
16141.5916116.060.12数据可信
供试品溶液-WC2484批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105126-10512652.40450.975.6352.4050.975.63
294723-9472347.21847.22
3104341-10434152.01352.01
499833-9983349.76549.77
5110987-11098755.32655.33
698487-9848749.09449.09
10min1183989-18398991.71689.543.8991.7989.613.89
2167869-16786983.68083.75
3181032-18103290.24290.32
4182994-18299491.22091.29
5186820-18682093.12793.21
6174995-17499587.23387.31
15min1194738-19473897.07493.513.3797.2993.723.37
2180753-18075390.10390.30
3188068-18806893.74993.96
4188698-18869894.06394.27
5193634-19363496.52496.75
6179610-17961089.53389.74
20min1196067-19606797.73795.002.5298.1095.352.52
2189463-18946394.44594.78
3191936-19193695.67896.03
4189817-18981794.62194.97
5193948-19394896.68197.05
6182213-18221390.83191.17
30min1196411-19641197.90896.522.5198.4297.022.50
2196830-19683098.11798.59
3194738-19473897.07497.57
4192021-19202195.72096.21
5197228-19722898.31698.83
6184542-18454291.99292.47
45min1198112-19811298.75697.952.1699.4198.592.16
2197587-19758798.49599.11
3200497-20049799.945100.59
4194577-19457796.99497.63
5199329-19932999.363100.02
6188856-18885694.14294.76
60min1197169-19716998.28698.532.0899.0999.322.08
2198764-19876499.08199.85
3199607-19960799.501100.29
4196769-19676998.08798.87
5203035-203035101.210102.02
6190640-19064095.03295.79
极限1198207-19820798.80499.651.2399.75100.581.23
2197297-19729798.35099.27
3200544-20054499.969100.91
4199927-19992799.661100.59
5204306-204306101.844102.80
6199123-19912399.260100.16
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%
112.311989081973251993101984011971731982230.48
212.271984521999701992110.54
单位质量响应值RSD%判断
16102.6016235.620.59数据可信
供试品溶液-WK2927批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199954-9995449.70251.9011.8449.7051.9011.84
2120585-12058559.96159.96
3103853-10385351.64151.64
4110632-11063255.01255.01
583612-8361241.57641.58
6107579-10757953.49453.49
10min1173832-17383286.43889.713.4086.5189.783.40
2184090-18409091.53991.63
3188758-18875893.86093.94
4177059-17705988.04388.13
5174494-17449486.76886.83
6184199-18419991.59391.67
15min1185150-18515092.06694.393.1192.2794.603.11
2187892-18789293.43093.66
3197443-19744398.17998.40
4188970-18897093.96694.18
5183043-18304391.01991.21
6196399-19639997.66097.88
20min1187623-18762393.29695.302.8393.6495.662.83
2191740-19174095.34395.71
3197544-19754498.22998.59
4191302-19130295.12595.48
5184003-18400391.49691.83
6197729-19772998.32198.69
30min1191882-19188295.41496.282.3795.9096.782.37
2191829-19182995.38895.90
3200541-20054199.720100.23
4193790-19379096.36396.86
5187141-18714193.05693.52
6196550-19655097.73598.25
45min1194252-19425296.59297.262.2697.2297.912.27
2196747-19674797.83398.49
3201957-201957100.424101.09
4194787-19478796.85897.50
5188523-18852393.74494.35
6197361-19736198.13898.80
60min1196961-19696197.93998.212.1898.7199.002.18
2197785-19778598.34999.15
3204455-204455101.666102.48
4196252-19625297.58798.37
5191123-19112395.03695.78
6198437-19843798.67399.48
极限1197853-19785398.38398.751.4599.3099.691.45
2198997-19899798.95299.90
3204129-204129101.504102.47
4197295-19729598.10699.04
5196226-19622697.57498.46
6197067-19706797.99298.95
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