FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products - Questions and Answers

https://www.gmp-navigator.com/files/guidemgr/UCM366082.pdf

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM366082.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery