【摘要】 使用差示扫描量热法(DSC)对甘露醇纯度进行测定。密封式铝坩埚封装样品,最佳实验条件为升温速率约0.7℃·min-1,样品量约2.5mg,氮气流速为20～40mL·min-1;纯度测定的RSD为0.016,纯度准确测定的下限为98%,通过F检验及t检验,该方法与药典法无显著差异。该方法简便、快速、准确,适合甘露醇等高纯度药品的纯度测定。更多还原

【Abstract】 Differential scanning calorimetry technique for the purity determination of mannitol was introduced and the influencing factors were investigated. In the experiment, hermetic aluminum pan was used to encapsulate samples. The optimal testing conditions were: heating rate 0.7℃·min -1 , sample weight ～2.5 mg and nitrogen gas flow rate 20～40 mL·min~ -1 . The experimental results showed that there were no significant variation between the results obtained by differential scanning calorimetry and pharmacopoeia method through ~ F~ - test and ~ t~ - test with a S.D. of 0.016. The propesed method is characterized with accuracy, convenience and practicality.更多还原