One would typically include tests where variability is seen, for example, impuritytest, assay, moisture, etc.
只需要对那些可能变化的项目进行测试,例如杂质测试,含量测试,水分等等。
2
As for assay: analysis results shall be compared, as for test for impurity: if chromatographic graphs are available, peaks of impurities shall be compared.
含量测定应比较两方法的分析结果,杂质测定若有色谱图,则应对比杂质峰的形状。
3
As to test for impurity: a certain amount of the impurity may be added to the sample to testify the accuracy and precision of the method.