Forced degradation studies to assess the stability of drugs and products

Saranjit Singh,Mahendra Junwal, Gajanan Modhe, H A Tiwari,Moolchand Kurmi, Neha Parashar, Padmaja Sidduri

TrAC Trends in Analytical Chemistry（2013）

Cited 172|Views4

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Abstract

•Global regulatory status of forced degradation studies.•Critical appraisal of official requirements.•Benefits of stress testing in assessing drug and product stability.•Executing a study meeting regulatory expectations in Quality by Design environment.•Selective examples of detailed reports in the literature.

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Key words

AAPH,ACVA,AIBN,ANDAs,API,ASEAN,BUD,CAD,CDER,CDSCO,CE,CE-MS,CE-NMR,CHMP,CPMP,CQA,CTA,CTD,DEREK,DoE,DP,DPI,EMA/EMEA,ELSD,EPARs,FDCs,FPP,GC,GC-MS,GCC,GDA,HPLC,HSA,ICH,IFPMA,INDs,IP,IPEC,LC-IR,LC-MS,LC-NMR,lx,MCC,MDI,NCEs,NDA,NF,NOM,OFAT,psi,QbD,QOS-PD,QWP,RH,RI,SFDA,TFDA,TGA,TOPKAT,TPD,UHPLC,UPLC,USFDA,USP,UV,WHO,WHOPARs

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