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Organic Imp Limits in API/DP

Important Note

  • This tool is intended to provide limits of organic impurities in new drug substances/ drug products in line with ICH Q3A & ICH Q3B guidance documents.
  • The following types of drug substances/products are not covered in the ICH Q3A and ICH Q3B guidelines: biological/biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation product and semi-synthetic products derived therefrom, herbal products, and crude products of animal or plant origin. Also excluded are: (1) extraneous contaminants that should not occur in new drug products and are more appropriately addressed as good manufacturing practice (GMP) issues, (2) polymorphic forms, and (3) enantiomeric impurities.
  • It is not intended to apply to new drug substances/ drug products used during the clinical research stage of development.

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  • Usage Rights: These tools are provided for informational and educational purposes only. They are intended to assist with calculations and are not a substitute for professional judgment or regulatory advice.
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