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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/

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)

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