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.

FDA Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States

Origin/Publisher:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070621.pdf

Content:
This guidance is intended to assist manufacturers in responding to the issuance of a new USP test requirement for the control of residual solvents in drug products marketed in the United States.

Go back

GMP Conferences by Topics