RISK ASSESSMENT, SCREENING AND CONTROLS OF ELEMENTAL IMPURITIES IN PHARMACEUTICAL DRUG PRODUCTS: A REVIEW

摘要

The scope of this article is to review and describe the steps involved in risk assessment of elemental impurities (EIs) in drug products based on the permitted daily exposure (PDE) limits for the twenty-four (24) elements that are considered as potential EIs. Screening and estimation of EIs in drug substances, excipients and drug products by Inductively Coupled Plasma Mass Spectrometry (ICP-MS) or Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) and their controls involved as referred in the general chapters & of the United States Pharmacopoeia (USP), Q3D guideline for Elemental Impurities as per International Conference on Harmonization (ICH) and Q3D Elemental Impurities: guidance for Industry as per U. S., Food and Drug Administration US-FDA (US-FDA).