FDA Guidance for Industry: NDAs: Impurities in Drug Substances (Feb. 2000)
Title:
FDA Guidance for Industry: NDAs: Impurities in Drug Substances (Feb. 2000)
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance/ , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070577.pdf
Document Type:
Guidance for industry
Content:
Guideline issued by CDER (FDA) on necessary identification and qualification for NDAs and drug master files of impurities in active substances manufactured by chemical synthesis (monographed and non-monographed drug substances)