1. PREAMBLE
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. It is not intended to apply to new drug substances used during the clinical research stage of development. The following types of drug substances are not covered in this guideline: biological/biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation product and semi-synthetic products derived therefrom, herbal products, and crude products of animal or plant origin.
Impurities in new drug substances are addressed from two perspectives: Chemistry Aspects include classification and identification of impurities, report generation, listing of impurities in specifications, and a brief discussion of analytical procedures; and Safety Aspects include specific guidance for qualifying those impurities that were not present, or were present at substantially lower levels, in batches of a new drug substance used in safety and clinical studies.
2. CLASSIFICATION OF IMPURITIESA
Impurities can be classified into the following categories: ·
Organic impurities (process- and drug-related) ·
Inorganic impurities ·
Residual solvents
Organic impurities can arise during the manufacturing process and/or storage of the new drug substance. They can be identified or unidentified, volatile or non-volatile, and include: ·
Starting materials ·
By-products
Intermediates ·
Degradation products ·
Reagents, ligands and catalysts
Inorganic impurities can result from the manufacturing process. They are normally known and identified and include: ·
Reagents, ligands and catalysts ·
Heavy metals or other residual metals ·
Inorganic salts ·
Other materials (e.g., filter aids, charcoal)
Solvents are inorganic or organic liquids used as vehicles for the preparation of solutions or suspensions in the synthesis of a new drug substance. Since these are generally of known toxicity, the selection of appropriate controls is easily accomplished (see ICH Guideline Q3C on Residual Solvents).
Excluded from this document are: (1) extraneous contaminants that should not occur in new drug substances and are more appropriately addressed as Good Manufacturing Practice (GMP) issues, (2) polymorphic forms, and (3) enantiomeric impurities.
Source: ICH, Pls check the follow
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