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# New Drug Product Impurities ICH Guidance
- URL: https://www.fdaweb.com/new-drug-product-impurities-ich-guidance/
- Published: 2021-09-30T12:00:00.000Z
- Updated: 2026-09-14T17:16:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150257

FDA has published a guidance, *Q3B(R2) Impurities in New Drug Products*, with recommendations for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesized new drug substances not previously registered in a region or International Conference on Harmonization (ICH) member state. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q3br-impurities-new-drug-products-revision-3?ref=fdaweb.com) revises a 5/1997 ICH guidance that was first revised in 2/2003\. This revision clarifies one of the attachments, the guidance says.