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%
114.476716396712106709306718696710356713370.06
214.566691396702306696840.12
单位质量响应值RSD%判断
46395.0945994.780.62数据可信
供试品溶液-2025011221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%
5min1307046-30704638.57038.452.9238.5738.452.93
2303783-30378338.16038.16
3317296-31729639.85839.86
4290596-29059636.50436.50
5306562-30656238.50938.51
6311226-31122639.09539.10
10min1586169-58616973.63373.671.9173.7073.731.91
2587964-58796473.85873.92
3599105-59910575.25875.32
4565709-56570971.06371.12
5588342-58834273.90673.97
6591483-59148374.30074.37
15min1748800-74880094.06293.651.2694.2593.841.26
2754449-75444994.77294.96
3747044-74704493.84194.03
4727354-72735491.36891.55
5746490-74649093.77293.96
6749083-74908394.09894.29
20min1794733-79473399.83299.981.32100.18100.321.32
2801651-801651100.701101.05
3779165-77916597.87698.22
4790988-79098899.36299.69
5810185-810185101.773102.12
6798787-798787100.341100.69
30min1793463-79346399.672100.011.27100.18100.521.27
2803144-803144100.889101.40
3779967-77996797.97798.49
4791729-79172999.45599.95
5808653-808653101.581102.09
6800031-800031100.498101.01
45min1796108-796108100.005100.031.37100.68100.711.37
2803157-803157100.890101.57
3779588-77958897.93098.60
4789788-78978899.21199.87
5811094-811094101.887102.57
6798315-798315100.282100.96
极限1793768-79376899.71199.741.35100.55100.581.35
2799104-799104100.381101.23
3777099-77709997.61798.45
4788258-78825899.01999.85
5808874-808874101.608102.46
6796741-796741100.084100.93
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%
114.476714006703986703686716026710776709690.09
214.566690076696776693420.08
单位质量响应值RSD%判断
46369.6645971.290.62数据可信
供试品溶液-2025011221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%
5min1298349-29834937.49834.9813.0837.5034.9813.08
2266944-26694433.55033.55
3288840-28884036.30236.30
4302789-30278938.05638.06
5303571-30357138.15438.15
6209415-20941526.32026.32
10min1577705-57770572.60868.3211.7072.6768.3811.70
2511065-51106564.23264.29
3569046-56904671.52071.58
4584993-58499373.52473.59
5590905-59090574.26774.33
6427846-42784653.77353.82
15min1736154-73615492.52288.379.1392.7188.559.13
2671895-67189584.44684.61
3734146-73414692.27092.45
4743388-74338893.43293.62
5748027-74802794.01594.20
6585247-58524773.55673.69
20min1778537-77853797.84996.824.8698.1997.144.88
2764157-76415796.04296.35
3793453-79345399.724100.06
4795753-795753100.013100.35
5792030-79203099.54599.89
6697953-69795387.72187.98
30min1779479-77947997.96899.040.9798.4799.520.99
2781340-78134098.20298.67
3794318-79431899.833100.33
4796742-796742100.137100.65
5793293-79329399.704100.21
6782756-78275698.38098.78
45min1781924-78192498.27599.200.7498.9499.840.75
2782533-78253398.35298.98
3792469-79246999.600100.27
4796543-796543100.112100.79
5791938-79193899.534100.21
6790102-79010299.30399.87
极限1779803-77980398.00898.930.7298.8499.740.72
2780392-78039298.08298.87
3789039-78903999.169100.00
4793064-79306499.675100.52
5790443-79044399.346100.19
6790178-79017899.312100.04
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