盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.302502652501732503062499382500222501410.07
210.332499782499322499550.02
单位质量响应值RSD%判断
24285.5324197.000.26数据可信
供试品溶液-2095120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%
5min1143931-14393159.07863.295.4259.0863.295.42
2155547-15554763.84663.85
3153024-15302462.81062.81
4164239-16423967.41367.41
10min1166755-16675568.44670.033.1968.6270.223.19
2172068-17206870.62770.82
3177699-17769972.93873.13
4165962-16596268.12168.32
15min1146702-14670260.21570.2810.2060.6070.6810.16
2186611-18661176.59677.00
3179960-17996073.86674.27
4171610-17161070.43970.85
20min1192537-19253779.02878.383.9879.5979.003.93
2189446-18944677.76078.39
3181789-18178974.61775.25
4200103-20010382.13482.75
30min1203130-20313083.37683.630.4584.1884.470.46
2204959-20495984.12784.99
3202988-20298883.31884.17
4203869-20386983.68084.54
45min1180657-18065774.15281.035.8375.2082.135.79
2206686-20668684.83685.95
3201965-20196582.89884.00
4200374-20037482.24583.36
60min1206426-20642684.72982.433.9286.0083.773.84
2198221-19822181.36182.73
3190882-19088278.34979.70
4207806-20780685.29686.66
极限1208380-20838085.53185.880.5287.0687.470.54
2210801-21080186.52588.14
3208691-20869185.65987.25
4209029-20902985.79887.42
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