药物杂质

药物杂质与药物的质量、安全性、稳定性密切相关。

The impurity is related to the quality , safety and stability .

药物杂质与药品质量、安全性及效能密切相关，杂质控制在药物开发研究中的重要性越来越受到重视。

The impurity is related to the quality , safety and efficacy .

褶合光谱仪在药物杂质检测中的应用

Drug impurity quantification by the limitation detection of the convolution spectrum system

药物杂质及其对安全性的影响

The effect of the impurity on drug safety

药物的杂质及杂质检查

The impurity of drug and check of the impurity

目的：利用褶合光谱仪中杂质限量检测功能对药物中杂质进行定量分析。

Objective : To quantify drug impurity by the limitation detection of the convolution spectrum system .

结论：方法简便、灵敏、结果准确，适用于药物的杂质限量检测。

CONCLUSION : The method is simple , sensitive and accurate , suitable for the pharmaceutical impurity limit test .

药物的杂质控制对于保证药物的效能，降低药物的不良反应起着很关键的作用。

The control of the impurity in guarantee the drug , lowering the bad reaction of the drug plays an important role .

结论本方法分离度好、精密度高、专属性强、灵敏度高，可用于麻黄生物碱类药物中杂质成分的定性和定量测定。

Conclusion This developed method , which is very simple , perfect precision , high sensitivity , and selectivity , can be used for the qualitative and quantitative determination of impurities of ephedrine alkaloid-type samples .

该法在等度洗脱下22min之内完成了12种磺胺类药物和样品杂质的分离。

The twelve sulfonamides and impurity in sample were completely separated in 22 min with isocratic elution .

化学药物复方制剂中杂质的检查与控制

Impurities in Compound Preparation of Chemical Drugs : Examination and Control

方法将褶合光谱法应用于药物稳定性试验、杂质限量（纯度）检查、背景干扰下的单组分定量、光谱重叠的双组分定量，并与常规的分析方法比较。

Methods Convolution spectrometry was applied in stability test , limit of impurity or purity test , quantitative analysis of individual and double components , and compared with routine method .

杂质一般与特定药物有关，药物中的杂质多数具有潜在的生物活性，有的甚至还可以与药物相互作用，影响药物的有效性和安全性，产生毒性作用。

Impurities is also generally related to their drug itself , the majority of impurities in drugs with potential biological activity , and some drug interactions can affect drug efficacy and safety , and even toxic effects .