The Research On Pregabalin API Quality

Pregabalin is the first drug product approved in the United States and Europe for both pains for the treatment of diabetic neuropathic pain and herpes zoster neuralgia pain.Pregabalin has the widest range of treatments for neuropathic pain in the international pharmaceutical market,and its efficacy is superior to other similar type of drugs.In view of the superior clinical efficacy of pregabalin drugs,the research on the quality of pregabalin bulk drugs and the development of good quality control methods to ensure product quality are of significant meaning for pharmaceutical research and product commerilization.This article develops and establishes a complete set of quality control standards and control methods through the research on the quality attributes and production processes of pregabalin bulk drugs,considering the regulatory requirements,with the purpose to control the quality of drugs and provide effective protection for patients..The first chapter of the article introduces the basic physical and chemical properties and synthetic processes of pregabalin bulk drugs,which are the basis and background knowledge of quality research.The second chapter studies how to control the quality of pregabalin drug substance.First,it studies the more complicated and critical part of the quality control of drug substance,which is impurity research and control.Then research and control of other quality attributes.The third and fourth chapters' development of analytical method to achieve quality control of pregabalin bulk drugs,and to optimize and validate these method to ensure for intended use.The fifth chapter is a study of the stability of pregabalin bulk drugs,providing supportive information on the quality assurance of drugs during storage and transportation.