浅谈强制降解试验 来源SFDA（Discussion on the source of forced degradation test SFDA）.docVIP

浅谈强制降解试验 来源SFDA（Discussion on the source of forced degradation test SFDA） Preliminary discussion on compulsory degradation test source: SFDA time: [2011.5.13] The compulsory degradation test is a series of tests to investigate the stability of a substance or a drug under severe experimental conditions. Generally speaking, the main purpose of this experiment is as follows: two. Through investigating the stability of the drug in a series of severe conditions, we know the inherent stability, degradation pathway and degradation products of the drug. For example, through high temperature degradation test, can understand the drug under the condition of high temperature is stable; if not stable, generally unstable conditions in which the drug is the degradation products by which degradation pathway. Second, these tests can, to some extent, verify the specificity of the analytical methods used to examine the degradation products. For innovative drugs, due to the nature of all aspects are not enough to understand, therefore, through forced degradation complete design test, can fully understand its stability characteristics, so as to design the formulation, process, and product storage condition and provides the beneficial reference. Therefore, for innovative drugs, it is important to understand the stability characteristics of drugs through forced degradation tests. For generic drugs, if fully explain the stability of the drug and the way of degradation and degradation products are full of literature, it is not necessary to repeat the test by forced degradation to understand these background knowledge. At this point, the main purpose of the mandatory degradation test is to verify the specificity of the analytical methods for the degradation products. And, as in domestic related substances research, qualitative research is generally not the relevant material, and no corresponding impurity reference, so the validation on the analysis method of related substances, it is diffic