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%
112.692113712114822108392107812105442110030.20
212.852125942126732126340.03
单位质量响应值RSD%判断
16627.5016547.390.35数据可信
供试品溶液-2025080321批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1174207-17420784.43984.920.7584.4484.920.75
2176312-17631285.46085.46
3176917-17691785.75385.75
4174664-17466484.66184.66
5175584-17558485.10785.11
6173463-17346384.07984.08
10min1187192-18719290.73391.250.5990.8691.380.59
2189029-18902991.62491.75
3189649-18964991.92492.05
4188592-18859291.41291.54
5188367-18836791.30391.43
6186732-18673290.51090.64
15min1193346-19334693.71693.810.7293.9894.070.72
2194359-19435994.20794.47
3195150-19515094.59194.86
4191763-19176392.94993.21
5194522-19452294.28694.55
6192076-19207693.10193.36
20min1195432-19543294.72795.160.8395.1395.570.83
2195726-19572694.87095.28
3198409-19840996.17096.58
4194635-19463594.34194.74
5198330-19833096.13296.54
6195480-19548094.75095.15
30min1198475-19847596.20296.611.1096.7597.161.10
2199134-19913496.52297.07
3201667-20166797.74998.30
4196554-19655495.27195.82
5202168-20216897.99298.54
6197945-19794595.94596.49
45min1198711-19871196.31797.131.4797.0197.821.47
2198527-19852796.22796.92
3203423-20342398.60099.30
4197038-19703895.50696.19
5204459-20445999.10399.80
6200144-20014497.01197.70
极限1197391-19739195.67797.141.9096.5197.981.89
2198618-19861896.27197.11
3203810-20381098.78899.64
4196491-19649195.24196.07
5206099-20609999.898100.74
6200041-20004196.96197.79
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%
112.692120702116822116832121442128232120800.23
212.852137182138262137720.04
单位质量响应值RSD%判断
16712.3716635.950.33数据可信
供试品溶液-2025080321批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1173729-17372983.77084.110.8383.7784.110.84
2177018-17701885.35685.36
3174675-17467584.22684.23
4174285-17428584.03884.04
5172661-17266183.25583.25
6174238-17423884.01584.02
10min1183949-18394988.69889.961.0988.8290.081.09
2190087-19008791.65791.79
3186534-18653489.94490.07
4186293-18629389.82889.95
5185627-18562789.50789.63
6186909-18690990.12590.25
15min1189139-18913991.20092.611.3391.4692.871.32
2195185-19518594.11594.38
3194392-19439293.73393.99
4190296-19029691.75892.02
5190103-19010391.66591.92
6193288-19328893.20193.46
20min1190651-19065191.92993.711.4692.3294.111.46
2198751-19875195.83596.24
3195777-19577794.40194.80
4192185-19218592.66993.07
5193924-19392493.50793.90
6194815-19481593.93794.34
30min1194389-19438993.73295.311.3694.2695.851.36
2200854-20085496.84997.40
3200398-20039896.62997.17
4195351-19535194.19594.73
5196457-19645794.72995.27
6198508-19850895.71896.26
45min1196943-19694394.96395.951.4395.6496.641.43
2202473-20247397.63098.33
3201879-20187997.34398.03
4196108-19610894.56095.24
5196502-19650294.75095.43
6200064-20006496.46897.15
极限1197996-19799695.47195.921.2096.2996.751.20
2201178-20117897.00597.85
3200745-20074596.79697.63
4195939-19593994.47995.30
5196619-19661994.80795.63
6201087-20108796.96197.79
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