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(%)94.94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%
114.536729576744496743346741826746536741150.10
214.456722376735386728880.14
单位质量响应值RSD%判断
46394.7046566.640.27数据可信
高温10天-供试品溶液-24041501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%
5min1213621-21362126.64122.0821.9826.6422.0821.98
2162278-16227820.23820.24
3145821-14582118.18618.19
4123998-12399815.46415.46
5219945-21994527.43027.43
6196527-19652724.50924.51
10min1390039-39003948.64241.8719.0248.6941.9019.02
2301136-30113637.55537.59
3291375-29137536.33836.37
4249123-24912331.06931.09
5408350-40835050.92650.97
6374248-37424846.67346.71
15min1520638-52063864.93056.6318.1665.0656.7418.17
2401125-40112550.02550.12
3400236-40023649.91450.00
4345064-34506443.03343.11
5549084-54908468.47768.61
6508377-50837763.40063.52
20min1617833-61783377.05167.8217.4077.2868.0117.40
2478821-47882159.71559.89
3484779-48477960.45860.63
4420344-42034452.42252.57
5655736-65573681.77882.02
6605154-60515475.47075.69
30min1701491-70149187.48480.7613.1887.8581.0713.20
2607281-60728175.73576.01
3585445-58544573.01273.29
4533569-53356966.54266.78
5759013-75901394.65895.04
6698555-69855587.11887.47
45min1725145-72514590.43488.676.9990.9489.117.03
2708345-70834588.33988.74
3669805-66980583.53283.93
4645972-64597280.56080.91
5787748-78774898.24198.78
6728789-72878990.88891.38
60min1723972-72397290.28891.733.4990.9592.333.53
2733660-73366091.49692.05
3724377-72437790.33890.87
4714952-71495289.16389.64
5786250-78625098.05498.76
6730097-73009791.05291.70
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(%)94.94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%
114.536736206743486743036740496741016740840.05
214.456734746744636739680.11
单位质量响应值RSD%判断
46392.5746641.380.38数据可信
高温10天-供试品溶液-24041501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%
5min1206020-20602025.67325.561.1625.6725.561.16
2204871-20487125.53025.53
3208603-20860325.99525.99
4206202-20620225.69625.70
5203172-20317225.31825.32
6201941-20194125.16525.16
10min1386965-38696548.22248.321.2948.2648.361.29
2391947-39194748.84248.88
3393986-39398649.09649.14
4380848-38084847.45947.50
5383552-38355247.79647.84
6389397-38939748.52548.57
15min1520313-52031364.83965.601.4964.9665.731.49
2533317-53331766.45966.58
3535775-53577566.76566.89
4515222-51522264.20464.33
5525008-52500865.42465.55
6529085-52908565.93266.05
20min1613567-61356776.45978.071.4276.6978.301.41
2634433-63443379.06079.29
3634305-63430579.04479.28
4617605-61760576.96377.19
5629004-62900478.38378.61
6630197-63019778.53278.76
30min1709380-70938088.39989.851.3688.7690.211.35
2724150-72415090.24090.61
3719724-71972489.68890.06
4726149-72614990.48990.85
5735389-73538991.64092.00
6711233-71123388.63088.99
45min1715556-71555689.16990.881.6789.6791.381.66
2727819-72781990.69791.21
3734308-73430891.50692.02
4738387-73838792.01492.52
5744470-74447092.77293.29
6714951-71495189.09389.60
60min1717111-71711189.36390.731.5790.0291.391.57
2728387-72838790.76891.44
3732798-73279891.31791.99
4736245-73624591.74792.41
5741715-74171592.42993.10
6712105-71210588.73989.40
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