盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
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%
110.912150712159292157242159122153792156030.18
2 11.042175222182102178660.23
单位质量响应值RSD%判断
19761.9619734.240.10数据可信
长期6月-供试品溶液-2025041521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1187388-18738885.22984.961.1085.2384.961.09
2190626-19062686.70286.70
3185425-18542584.33784.34
4185472-18547284.35884.36
5186534-18653484.84184.84
6185369-18536984.31184.31
10min1199014-19901490.51790.420.9390.6690.560.93
2202309-20230992.01692.16
3197292-19729289.73489.87
4197715-19771589.92690.07
5198701-19870190.37590.52
6197749-19774989.94290.08
15min1205852-20585293.62793.290.8793.9293.580.87
2208326-20832694.75395.05
3203405-20340592.51492.80
4204704-20470493.10593.40
5204387-20438792.96193.25
6203951-20395192.76393.05
20min1208585-20858594.87094.990.8395.3295.440.83
2212246-21224696.53696.99
3207597-20759794.42194.87
4208124-20812494.66195.11
5208770-20877094.95595.40
6207736-20773694.48494.93
30min1211896-21189696.37696.451.0296.9897.051.02
2216023-21602398.25398.87
3210932-21093295.93896.54
4210866-21086695.90896.51
5212670-21267096.72897.33
6209949-20994995.49196.09
极限1217474-21747498.91398.511.0099.6899.281.01
2220409-220409100.248101.03
3214733-21473397.66798.43
4215929-21592998.21198.97
5216441-21644198.44499.21
6214548-21454897.58398.34
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