关键词: 国际人用药品注册技术协调会, 每日允许暴露量, 电感耦合等离子体质谱, 欧洲药典, 日本药典, 美国药典

Abstract:

Elemental impurities (EIs) in drug products are a specific class of inorganic contaminants that may originate from various sources. These residual impurities provide no therapeutic benefit to patients and, in some cases, may even catalyze the degradation of drug substances. Therefore, their levels in drug products must be controlled within acceptable limits. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) approved the harmonised Guideline for Elemental Impurities (ICH Q3D) on November 12, 2014. On January 10, 2020, the National Medical Products Administration (NMPA) announced the adoption of the ICH Q3D principles in China. Inductively coupled plasma mass spectrometry (ICP-MS) offers distinct advantages in detecting trace levels of EIs in drug products. Various validation criteria for the analytical procedure of ICP-MS are specified in the pharmacopoeias. This study compared differences in the validation criteria for ICP-MS, highlighting that the criteria adopted in the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) were particularly specific and detailed, thereby facilitating analytical method development for drug quality control. The aim was to provide a useful reference for analysts conducting EI determination using ICP-MS.

Key words: International Council for Harmonisation, Permitted daily exposures, Inductively coupled plasma-mass spectrometry, European Pharmacopoeia, Japanese Pharmacopoeia, United States Pharmacopeia-National Formulary