氨溴酸替格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.476711206714736718696713496714576714540.05
214.566711116709886710500.02
单位质量响应值RSD%判断
46403.1846088.600.49数据可信
供试品溶液-2025011021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%
5min1295683-29568337.10235.774.7837.1035.774.78
2300595-30059537.71837.72
3286970-28697036.00836.01
4265845-26584533.35833.36
5271706-27170634.09334.09
6289532-28953236.33036.33
10min1566599-56659971.09669.422.8571.1669.482.85
2563489-56348970.70570.77
3558302-55830270.05470.11
4533477-53347766.93967.00
5533058-53305866.88766.94
6564755-56475570.86470.92
15min1727454-72745491.27989.742.2291.4689.922.22
2729619-72961991.55191.73
3712316-71231689.38089.56
4702383-70238388.13388.30
5691544-69154486.77386.94
6728011-72801191.34991.53
20min1802535-802535100.70097.812.66101.0398.132.66
2782436-78243698.17898.51
3783144-78314498.26798.59
4765909-76590996.10596.42
5746172-74617293.62893.94
6796691-79669199.967100.30
30min1805031-805031101.01398.422.29101.5198.902.29
2791321-79132199.29399.79
3785644-78564498.58199.07
4771610-77161096.82097.29
5755732-75573294.82895.30
6796592-79659299.955100.45
45min1802439-802439100.68898.022.43101.3698.682.43
2791167-79116799.27499.94
3775862-77586297.35398.01
4765530-76553096.05796.69
5754699-75469994.69895.32
6797485-797485100.067100.73
极限1797878-797878100.11697.552.26100.9598.372.26
2775950-77595097.36498.19
3779576-77957697.81998.64
4766531-76653196.18396.98
5750589-75058994.18294.97
6794039-79403999.634100.47
氨溴酸替格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.476700586710686697076703426701456702640.08
214.566698266702556700400.05
单位质量响应值RSD%判断
46320.9446019.230.47数据可信
供试品溶液-2025011021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%
5min1293021-29302136.82835.904.5236.8335.904.52
2280786-28078635.29035.29
3261736-26173632.89632.90
4293789-29378936.92436.92
5296102-29610237.21537.22
6288236-28823636.22736.23
10min1572808-57280871.99369.952.7572.0570.012.75
2556971-55697170.00270.06
3527413-52741366.28766.34
4561386-56138670.55770.62
5559409-55940970.30970.37
6561323-56132370.54970.61
15min1741694-74169493.21991.012.0593.4091.192.05
2731390-73139091.92492.10
3697330-69733087.64387.81
4726933-72693391.36491.54
5722085-72208590.75490.93
6725302-72530291.15991.34
20min1815878-815878102.54399.791.69102.88100.121.69
2801515-801515100.737101.07
3776588-77658897.60497.92
4788335-78833599.08199.41
5789526-78952699.23099.56
6792062-79206299.54999.88
30min1815694-815694102.519100.961.75103.03101.461.75
2804185-804185101.073101.57
3789947-78994799.28399.76
4823900-823900103.551104.05
5790359-79035999.33599.83
6795583-79558399.992100.49
45min1815586-815586102.506100.371.98103.18101.031.97
2821028-821028103.190103.85
3786247-78624798.81899.46
4789059-78905999.17299.84
5784937-78493798.65499.32
6794468-79446899.852100.51
极限1813276-813276102.215101.382.42103.06102.212.41
2800649-800649100.628101.47
3783290-78329098.44799.25
4831798-831798104.543105.38
5787623-78762398.99199.82
6823234-823234103.467104.30
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