Effects of manufacturing process and process control on related substances of synthetic peptide drugs
HU Yu-xi
JIANG Yu
HAN Tian-jiao
Abstract：Referring to relevant guidelines and electronic journals,this paper mainly discusses the effects of starting materials,process optimization and intermediates control on the quality of synthetic peptide drugs,especially related substances,based on QbD concept.The objective is to reduce related substances of synthetic peptide drugs through enhancing the process control.
Keywords：synthetic peptidemanufacturing processprocess controlrelated substances
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2143-2148 )