Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

ANDAs: Impurities in Drug Products
Internet:	http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072861.pdf
Origin/Publisher:	FDA
Content:	This guidance provides recommendations on what chemistry, manufacturing and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of degradation products in drug products.
Status:	Final
Document Type:	Guidance for Industry