U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. ANDAs: Impurities in Drug Products
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

ANDAs: Impurities in Drug Products Guidance for Industry November 2010

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0584
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations on what chemistry, manufacturing, and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0584.

Back to Top