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D230603FK对照品来源自制对照品使用方法直接使用
对照品含量(%)97.04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%
1 14.261472851473931471721471421470931472170.09
2 13.691417011415671416340.07
单位质量响应值RSD%判断
10323.7710345.800.16数据可信
供试品溶液-24102101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%
5min158243-5824339.37539.314.2239.3839.314.22
257831-5783139.09739.10
358639-5863939.64339.64
458606-5860639.62139.62
561597-6159741.64341.64
653948-5394836.47236.47
10min178886-7888653.33153.522.4053.7753.962.39
278127-7812752.81853.25
382645-8264555.87356.31
477255-7725552.22952.67
579793-7979353.94454.41
678319-7831952.94853.35
15min191561-9156161.90061.041.9162.9362.071.89
291769-9176962.04163.06
389408-8940860.44561.51
491227-9122761.67562.70
590533-9053361.20562.27
687236-8723658.97659.97
20min1102375-10237569.21168.663.0370.9370.372.97
296634-9663465.33067.04
3105164-10516471.09772.83
4104192-10419270.44072.15
5100441-10044167.90469.65
6100527-10052767.96269.61
30min1113661-11366176.84176.382.4879.3378.862.42
2110451-11045174.67177.11
3116753-11675378.93181.45
4114725-11472577.56080.05
5109132-10913273.77976.28
6113160-11316076.50278.91
45min1120972-12097281.78483.242.8385.1286.562.76
2118444-11844480.07583.34
3125178-12517884.62788.03
4128563-12856386.91690.27
5122658-12265882.92486.24
6122934-12293483.11086.36
60min1133283-13328390.10788.322.1394.3692.562.06
2127641-12764186.29290.45
3128398-12839886.80491.14
4132572-13257289.62693.94
5133564-13356490.29794.53
6128343-12834386.76790.94
90min1136064-13606491.98790.221.9697.2495.451.91
2129512-12951287.55792.67
3132146-13214689.33894.64
4135093-13509391.33096.64
5135788-13578891.80097.04
6132140-13214089.33494.48
极限1131607-13160788.97489.011.9295.2595.241.88
2129678-12967887.67093.76
3132114-13211489.31695.61
4134070-13407090.63996.97
5134514-13451490.93997.20
6127963-12796386.51092.64
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