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%
1 14.626767326766046769126793266784786776100.19
2 14.636797866784836791340.14
单位质量响应值RSD%判断
46348.1546420.640.12数据可信
供试品溶液-2025011121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%
5min1243190-24319030.42325.8825.5330.4225.8825.54
2173585-17358521.71621.72
3232082-23208229.03429.03
4239547-23954729.96829.97
5113298-11329814.17414.17
6239385-23938529.94729.95
10min1479771-47977160.02055.2517.1760.0755.2917.17
2395996-39599649.54049.58
3488397-48839761.09961.15
4485861-48586160.78260.83
5306165-30616538.30238.33
6493437-49343761.73061.78
15min1657247-65724782.22376.0114.0482.3776.1414.05
2545894-54589468.29268.41
3651314-65131481.48081.63
4668842-66884283.67383.82
5460847-46084757.65357.74
6661320-66132082.73282.89
20min1756235-75623594.60688.7311.3894.8988.9911.39
2648244-64824481.09681.33
3763640-76364095.53395.82
4760810-76081095.17995.47
5571719-57171971.52371.71
6754737-75473794.41994.71
30min1789958-78995898.82597.763.3199.2798.173.35
2765157-76515795.72296.09
3799984-799984100.079100.52
4798451-79845199.888100.34
5736159-73615992.09592.40
6798888-79888899.942100.39
45min1808275-808275101.117100.980.59101.73101.550.59
2806455-806455100.889101.42
3804997-804997100.706101.32
4815015-815015101.960102.58
5807754-807754101.051101.51
6800537-800537100.149100.76
极限1804588-804588100.655101.382.01101.43102.121.95
2799142-79914299.974100.67
3793639-79363999.286100.07
4824158-824158103.104103.89
5835962-835962104.580105.20
6804821-804821100.684101.47
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%
1 14.626737376743066755396758476735606745980.16
2 14.636771196748736759960.24
单位质量响应值RSD%判断
46142.1346206.150.10数据可信
供试品溶液-2025011121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%
5min1272430-27243034.23732.085.0834.2432.085.08
2248960-24896031.28731.29
3248420-24842031.21931.22
4269749-26974933.90033.90
5252027-25202731.67331.67
6239845-23984530.14230.14
10min1511008-51100864.21961.244.2964.2861.294.29
2479975-47997560.31960.37
3481842-48184260.55460.61
4512150-51215064.36364.42
5480984-48098460.44660.50
6457751-45775157.52657.58
15min1666774-66677483.79481.473.1283.9681.633.13
2637219-63721980.08080.23
3640600-64060080.50580.66
4677677-67767785.16585.33
5644610-64461081.00981.16
6622937-62293778.28578.43
20min1750343-75034394.29794.142.3194.6094.432.31
2743258-74325893.40693.69
3745843-74584393.73194.02
4775366-77536697.44197.75
5756859-75685995.11595.40
6722801-72280190.83591.11
30min1772471-77247197.07798.971.6097.5499.421.60
2787099-78709998.91699.36
3791972-79197299.52899.97
4806368-806368101.337101.81
5792380-79238099.579100.03
6774711-77471197.35997.79
45min1775857-77585797.50399.021.2698.1399.631.26
2786873-78687398.88799.49
3789890-78989099.26799.88
4802095-802095100.800101.44
5794508-79450899.847100.46
6778286-77828697.80898.40
极限1766895-76689596.37798.801.8097.1699.581.80
2786450-78645098.83499.61
3792341-79234199.575100.35
4808286-808286101.578102.38
5787078-78707898.91399.69
6776257-77625797.55398.31
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