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%
114.476693916691416699416691576693336693930.05
214.566690966692266691610.02
单位质量响应值RSD%判断
46260.7545958.860.47数据可信
供试品溶液-2025011121批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1261768-26176832.94335.3821.7632.9435.3821.76
2320034-32003440.27640.28
3317952-31795240.01440.01
4164736-16473620.73220.73
5304043-30404338.26338.26
6318414-31841440.07240.07
10min1492580-49258061.99065.7216.8762.0565.7816.88
2578274-57827472.77572.84
3573734-57373472.20372.27
4356277-35627744.83744.87
5547038-54703868.84468.91
6585276-58527673.65673.72
15min1649745-64974581.76985.2513.2281.9385.4213.23
2729636-72963691.82392.01
3732303-73230392.15992.35
4506916-50691663.79463.90
5709370-70937089.27389.45
6736415-73641592.67692.87
20min1746718-74671893.97395.029.2394.2795.339.25
2791049-79104999.55299.89
3802473-802473100.990101.33
4618130-61813077.79078.01
5786255-78625598.94999.28
6785572-78557298.86399.21
30min1777909-77790997.89898.872.2098.3599.342.25
2794407-79440799.974100.48
3805906-805906101.422101.93
4755924-75592495.13195.48
5793383-79338399.846100.34
6786386-78638698.96599.47
45min1780696-78069698.24999.561.1798.86100.201.20
2793556-79355699.867100.54
3806685-806685101.520102.20
4784491-78449198.72799.23
5793882-79388299.908100.57
6787430-78743099.09699.77
极限1779158-77915898.05599.361.1298.83100.161.15
2792530-79253099.738100.58
3804261-804261101.215102.06
4783300-78330098.57799.25
5791894-79189499.658100.48
6786228-78622898.94599.78
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%
114.476690156691506689456690586687226689780.03
214.566701816700936701370.01
单位质量响应值RSD%判断
46232.0746025.890.32数据可信
供试品溶液-2025011121批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1280277-28027735.25733.1621.6835.2633.1621.68
2297786-29778637.46037.46
3313992-31399239.49939.50
4202792-20279225.51025.51
5305897-30589738.48038.48
6180811-18081122.74522.75
10min1518400-51840065.21262.8318.3865.2762.8818.38
2563844-56384470.92970.99
3581339-58133973.12973.20
4407656-40765651.28151.32
5562165-56216570.71870.78
6363313-36331345.70345.74
15min1679679-67967985.50082.6414.9785.6782.8014.98
2725300-72530091.23991.42
3741091-74109193.22593.41
4561641-56164170.65270.78
5726000-72600091.32791.51
6507895-50789563.89164.00
20min1771686-77168697.07493.3710.3697.3893.6710.38
2789899-78989999.36599.70
3804317-804317101.179101.52
4672677-67267784.61984.87
5794867-79486799.990100.32
6620071-62007178.00278.22
30min1794360-79436099.92698.862.08100.4099.322.14
2790416-79041699.43099.93
3803985-803985101.137101.65
4771173-77117397.01097.40
5794451-79445199.938100.44
6760993-76099395.72996.08
45min1797137-797137100.27699.971.19100.91100.591.21
2790553-79055399.448100.11
3806749-806749101.485102.17
4778756-77875697.96498.51
5796104-796104100.146100.81
6799117-799117100.525101.03
极限1795310-795310100.04699.791.12100.85100.581.14
2789168-78916899.273100.10
3803172-803172101.035101.88
4777928-77792897.85998.57
5794974-794974100.004100.84
6799333-799333100.552101.23
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