Analysis on the quality control of active pharmaceutical ingredients of deuterated drugs
Deuterated drugs are obtained by substituting deuterium and hydrogen atoms at specific sites on drug molecules,which are receiving considerable attention due to the advantages on pharmacokinetics.A number of deuterated drugs have been approved in China and abroad at present.Currently,there are no established guidelines from the FDA or other governing bodies outlining how to address deuterated APIs.In this paper,the specificity of quality control of deuterated drugs,especially identification,deuterated ratio and impurity test,was discussed based on the documents,quality analysis and validation,and verification of quality specification on deuterated drugs,in order to provide a reference for the quality control of deuterated drugs.
NETL
NSTL
万方数据
