氢溴酸替格列汀片项目信息
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%
114.796761756753196752756754506752786754990.06
214.846743176742496742830.01
单位质量响应值RSD%判断
45672.6845436.860.37数据可信
供试品溶液-1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1323955-32395541.26631.3131.5341.2731.3131.53
2298159-29815937.98037.98
3103362-10336213.16613.17
4272193-27219334.67234.67
5231937-23193729.54429.54
6245158-24515831.22831.23
10min1620369-62036979.02365.9221.5179.0965.9721.52
2588538-58853874.96875.03
3305208-30520838.87838.90
4549788-54978870.03270.09
5529849-52984967.49367.54
6511044-51104465.09765.15
15min1772922-77292298.45587.4916.2398.6687.6616.24
2757316-75731696.46796.66
3468351-46835159.65959.75
4724226-72422692.25292.43
5710982-71098290.56590.73
6687418-68741887.56487.72
20min1794849-794849101.24896.5810.71101.6196.8810.73
2787985-787985100.374100.72
3592807-59280775.51275.70
4789863-789863100.613100.94
5797519-797519101.589101.90
6786132-786132100.138100.44
30min1793353-793353101.058100.182.52101.59100.652.58
2787178-787178100.271100.79
3748077-74807795.29195.60
4788623-788623100.455100.95
5798584-798584101.724102.21
6803117-803117102.302102.78
45min1791661-791661100.842100.731.07101.54101.361.10
2785328-785328100.036100.72
3780105-78010599.37099.84
4786863-786863100.231100.89
5797917-797917101.639102.29
6802670-802670102.245102.89
极限1789268-789268100.538100.521.04101.41101.321.07
2784380-78438099.915100.77
3779031-77903199.23499.87
4784728-78472899.959100.79
5796427-796427101.449102.27
6800896-800896102.019102.83
氢溴酸替格列汀片项目信息
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%
114.796726386729116727276729366729936728410.03
214.846748746747096747920.02
单位质量响应值RSD%判断
45492.9745471.160.04数据可信
供试品溶液-24030401批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1268304-26830434.23139.608.3234.2339.608.33
2325299-32529941.50341.50
3313122-31312239.94939.95
4315938-31593840.30840.31
5296154-29615437.78437.78
6343540-34354043.83043.83
10min1540175-54017568.91776.476.0168.9776.546.02
2626386-62638679.91779.99
3593880-59388075.76975.84
4609098-60909877.71177.78
5583946-58394674.50274.56
6642858-64285882.01882.09
15min1720967-72096791.98497.883.7292.1698.073.72
2793262-793262101.207101.41
3759713-75971396.92797.12
4777831-77783199.23899.44
5754046-75404696.20496.39
6797184-797184101.708101.92
20min1798005-798005101.812103.162.01102.14103.522.01
2827062-827062105.519105.89
3820168-820168104.640104.99
4813439-813439103.781104.14
5782099-78209999.783100.13
6810658-810658103.427103.81
30min1800272-800272102.102103.371.96102.60103.901.96
2827909-827909105.628106.17
3822464-822464104.933105.46
4815023-815023103.984104.52
5784470-784470100.085100.60
6811171-811171103.492104.04
45min1800819-800819102.171103.161.86102.84103.861.86
2825699-825699105.346106.07
3819290-819290104.528105.23
4812089-812089103.609104.32
5783226-78322699.927100.61
6810164-810164103.364104.09
极限1799439-799439101.995102.971.87102.83103.841.88
2823366-823366105.048105.95
3817300-817300104.274105.15
4813205-813205103.752104.63
5781186-78118699.666100.51
6808054-808054103.094103.99
氢溴酸替格列汀片项目信息
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%
114.793368233367173368203369543367793368190.03
214.843359003362443360720.08
单位质量响应值RSD%判断
22773.4322646.360.40数据可信
供试品溶液-2批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104267-10426726.64237.0026.6226.6437.0026.62
2180139-18013946.02946.03
3156685-15668540.03640.04
4110385-11038528.20528.21
5121076-12107630.93730.94
6196232-19623250.14150.14
10min1263790-26379067.40376.9411.9967.4577.0012.00
2336306-33630685.93386.01
3322157-32215782.31782.38
4266038-26603867.97868.02
5276907-27690770.75570.81
6341390-34139087.23287.32
15min1359942-35994291.97296.794.5592.1396.984.57
2393920-393920100.654100.87
3396639-396639101.349101.55
4360559-36055992.13092.29
5369921-36992194.52294.69
6391853-391853100.126100.35
20min1395829-395829101.142101.421.25101.45101.771.24
2393871-393871100.641101.03
3401650-401650102.629103.00
4392935-392935100.402100.72
5404463-404463103.348103.67
6392813-392813100.371100.77
30min1396389-396389101.285101.351.41101.76101.871.39
2392412-392412100.269100.82
3401115-401115102.492103.04
4393518-393518100.551101.03
5405365-405365103.578104.08
6391033-39103399.916100.48
45min1395870-395870101.152101.311.44101.80102.001.42
2393347-393347100.508101.23
3400245-400245102.270102.98
4392913-392913100.397101.05
5405983-405983103.736104.41
6390596-39059699.805100.53
极限1394092-394092100.698100.821.40101.51101.681.38
2389321-38932199.479100.37
3398966-398966101.943102.83
4391747-391747100.099100.91
5403321-403321103.056103.90
6390036-39003699.662100.56
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