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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.

Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Short Title:Q6A
Internet:http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm134966.htm
Origin/Publisher:Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Content:This guidance is intended to assist in the establishment of a single set of global specifications for new drug substances and new drug products.
Document Type:FDA Guidance for Industry