The role of degradant profiling in active pharmaceutical ingredients and drug products.
Forced degradation studies are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. In order to fulfill development and regulatory needs, this publication provides a roadmap for when and how to perform studies, helpful tools in designing rugged scientific studies, and guidance on how to record and communicate results.
Alsante
Karen M
KM
Pfizer Global Research and Development, Analytical Research and Development, Eastern Point Road, Groton, CT 06340, USA. karen.m.alsante@pfizer.com
Ando
Akemi
A
Brown
Roland
R
Ensing
Janice
J
Hatajik
Todd D
TD
Kong
Wei
W
Tsuda
Yoshiko
Y
D000465:Algorithms; D004340:Drug Contamination / Q000331:legislation & jurisprudence; D004355:Drug Stability; D005544:Forecasting; D004364:Pharmaceutical Preparations / Q000032:analysis
D004364:Pharmaceutical Preparations