Some Basic Facts about Forced Degradation Test Benefits of forced degradation test
The degradation pathway of the drug is closely related to the molecular structure of the drug. The ester group or amide bond in the molecular structure may be hydrolyzed under acid-base catalysis conditions.
Provide support for drug safety. When toxicologically relevant impurities are not readily available, toxicological evaluation of samples degraded to a certain extent can provide a supportive basis for drug safety and impurity limit determination.
It is helpful for metabolite research. Some degradation products are also metabolites, and the metabolites produced by degrading test samples can be used for confirmatory studies and analysis.
Contribute to the development of active pharmaceutical ingredient (API) technology, formulation process, and the screening of drug salt and crystal forms. When the degradation impurities have toxic structures, the production of impurities can be avoided by changing the process route. The process parameters can also be controlled to ensure that the impurities are at an acceptable level. The forced degradation results of different crystalline and salt forms of drugs can indicate their stability.
Guide the development of drug packaging systems and determine storage conditions. Degradation test results can suggest drug susceptibility factors. The results of forced degradation testing, influencing factor testing, accelerated testing, and long-term testing together support drug packaging and storage conditions.
Purpose of forced degradation test The purpose of the forced degradation study is to understand the degradation products and degradation pathways of drugs under different destruction conditions. The forced degradation test can provide a useful reference for the establishment of analytical methods, the formulation of instructions and the determination of formulation design. Degradation pathways