他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源欧洲对照品使用方法直接使用
对照品含量(%)97.8对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.313145531387312863135131158313270.36
214.203174831479316140.61
单位质量响应值RSD%判断
2189.172226.341.20数据可信
供试品溶液-24102102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%
5min19803-980331.26933.9918.9131.2733.9918.91
29286-928629.62029.62
310568-1056833.70933.71
410489-1048933.45733.46
59192-919229.32029.32
614594-1459446.55146.55
10min116233-1623351.77949.137.0552.1349.517.06
215002-1500247.85248.18
313628-1362843.46943.84
416216-1621651.72452.10
514930-1493047.62247.95
616406-1640652.33052.85
15min119652-1965262.68460.169.7563.6161.099.67
218654-1865459.50160.36
315750-1575050.23851.10
417989-1798957.38058.33
520591-2059165.67966.53
620536-2053665.50466.60
20min124016-2401676.60467.9810.0678.2269.579.95
220867-2086766.56068.08
317500-1750055.82057.24
421557-2155768.76170.34
521955-2195570.03071.61
621982-2198270.11671.94
30min125965-2596582.82178.294.0085.2980.644.05
224490-2449078.11680.38
323007-2300773.38675.42
425066-2506679.95382.30
524166-2416677.08379.45
624570-2457078.37180.98
45min126437-2643784.32685.247.1387.7288.467.06
227483-2748387.66390.79
323029-2302973.45676.31
427355-2735587.25590.49
527865-2786588.88192.10
628173-2817389.86493.34
60min127518-2751887.77589.367.3192.1093.527.22
229619-2961994.47698.58
324122-2412276.94280.61
429257-2925793.32197.53
528436-2843690.70394.91
629140-2914092.94897.42
90min129681-2968194.67493.507.6799.9898.657.59
230015-3001595.739100.89
324886-2488679.37983.90
430770-3077098.147103.39
529516-2951694.14899.36
631001-3100198.884104.39
极限129245-2924593.28390.876.3399.6497.076.32
228486-2848690.86297.08
324923-2492379.49784.90
429863-2986395.254101.59
529283-2928393.40499.67
629136-2913692.93599.54
他克莫司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源欧洲对照品使用方法直接使用
对照品含量(%)97.8对照品水分(%)0对照品稀释倍数17500
标示量(mg)1供试品稀释倍数1.4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.311525111525581523751526671524101525040.08
214.201510491510061510280.03
单位质量响应值RSD%判断
10657.1610635.770.15数据可信
供试品溶液-24102101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%
5min158657-5865738.79638.402.7838.8038.402.78
260010-6001039.69139.69
358856-5885638.92838.93
457298-5729837.89737.90
558197-5819738.49238.49
655306-5530636.58036.58
10min182211-8221154.37554.952.2254.8155.382.22
284104-8410455.62756.07
385068-8506856.26456.70
480601-8060153.31053.73
584826-8482656.10456.53
681665-8166554.01354.42
15min189637-8963759.28662.914.6660.3263.944.59
290485-9048559.84760.91
3100098-10009866.20567.26
496075-9607563.54464.56
599657-9965765.91366.96
694712-9471262.64363.65
20min198171-9817164.93168.454.5766.6270.194.48
298165-9816564.92766.65
3107411-10741171.04272.84
4108982-10898272.08173.80
5102014-10201467.47269.26
6106227-10622770.25971.96
30min1111779-11177973.93178.404.3776.3580.904.30
2115786-11578676.58179.03
3127403-12740384.26586.85
4118214-11821478.18780.71
5118225-11822578.19480.73
6119807-11980779.24181.72
45min1118552-11855278.41185.134.9481.6588.504.84
2125433-12543382.96286.26
3134078-13407888.68092.20
4126578-12657883.71987.11
5134807-13480789.16292.56
6132856-13285687.87191.24
60min1129646-12964685.74888.103.2089.8692.423.17
2127792-12779284.52288.74
3138122-13812291.35495.86
4131175-13117586.76091.08
5135407-13540789.55993.95
6137102-13710290.68095.02
90min1132038-13203887.33092.734.2292.3998.024.16
2134408-13440888.89894.06
3147828-14782897.774103.29
4141332-14133293.47798.76
5141895-14189593.85099.24
6143677-14367795.028100.38
极限1131749-13174987.13992.773.7393.1799.103.70
2137008-13700890.61896.76
3146619-14661996.974103.58
4141032-14103293.27999.60
5141741-14174193.748100.18
6143463-14346394.887101.29
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