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%
114.476698076699566698296696916696936697950.02
214.566666156666416666280.01
单位质量响应值RSD%判断
46288.5345784.890.78数据可信
供试品溶液-2025011221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%
5min1285182-28518235.94736.364.2235.9536.364.22
2289894-28989436.54136.54
3279486-27948635.22935.23
4302668-30266838.15138.15
5272034-27203434.29034.29
6301689-30168938.02838.03
10min1541831-54183168.29868.762.7768.3668.822.77
2549434-54943469.25669.32
3538355-53835567.86067.92
4568512-56851271.66171.72
5523418-52341865.97766.03
6551587-55158769.52869.59
15min1711022-71102289.62489.501.9589.8089.671.95
2702639-70263988.56888.74
3708943-70894389.36289.53
4729655-72965591.97392.16
5689129-68912986.86587.03
6718646-71864690.58590.76
20min1790275-79027599.61499.091.2799.9499.421.27
2777418-77741897.99498.32
3789088-78908899.46599.79
4794574-794574100.156100.49
5770479-77047997.11997.43
6794878-794878100.195100.52
30min1794591-794591100.15899.671.50100.65100.161.50
2778684-77868498.15398.64
3793762-793762100.054100.54
4802374-802374101.139101.64
5773775-77377597.53498.01
6801070-801070100.975101.47
45min1795966-795966100.33299.871.32100.99100.531.32
2780174-78017498.34198.99
3795383-795383100.258100.91
4801363-801363101.012101.68
5778650-77865098.14998.79
6802351-802351101.136101.80
极限1793135-79313599.97599.581.50100.80100.401.50
2778204-77820498.09398.91
3792144-79214499.850100.67
4802067-802067101.101101.94
5773383-77338397.48598.28
6801049-801049100.972101.81
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%
114.476693116692716692006690266693116692240.02
214.566657726664526661120.08
单位质量响应值RSD%判断
46249.0745749.450.77数据可信
供试品溶液-2025011221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%
5min1286957-28695736.20036.542.2936.2036.542.29
2302248-30224838.12938.13
3288548-28854836.40136.40
4290505-29050536.64836.65
5283455-28345535.75935.76
6285998-28599836.07936.08
10min1539941-53994168.11569.962.0168.1870.022.01
2569135-56913571.79871.86
3557218-55721870.29570.36
4550119-55011969.39969.46
5546425-54642568.93368.99
6564608-56460871.22771.29
15min1703310-70331088.72490.991.5288.9091.171.51
2734635-73463592.67692.86
3726633-72663391.66791.84
4718115-71811590.59290.77
5717492-71749290.51490.69
6727517-72751791.77891.96
20min1780041-78004198.40499.861.4098.73100.191.39
2788249-78824999.44099.78
3808182-808182101.954102.28
4799050-799050100.802101.13
5793673-793673100.124100.45
6780357-78035798.44498.78
30min1784684-78468498.990100.151.2099.48100.651.19
2789786-78978699.634100.14
3800462-800462100.980101.48
4807725-807725101.897102.39
5797101-797101100.556101.05
6783648-78364898.85999.36
45min1785100-78510099.043100.311.2099.69100.971.19
2790982-79098299.785100.45
3800266-800266100.956101.62
4808681-808681102.017102.68
5800535-800535100.990101.65
6785464-78546499.08899.75
极限1783497-78349798.840100.071.2699.66100.901.25
2788911-78891199.523100.36
3798792-798792100.770101.61
4807203-807203101.831102.67
5798905-798905100.784101.61
6782215-78221598.67999.50
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