Understanding new harmonized regulations on elemental impurities

New harmonized ICH Q3D and USP 232 & 233 methodologies come in to force on January 1, 2018. We have created and updated this popular primer to help pharmaceutical manufacturers and contract laboratories understand and implement new methodologies for the determination of elemental impurities in drugs, drug products, raw drug materials, and dietary supplements.

Order your free print copy of this newly updated primer today and get an electronic copy to download instantly, together with a NEW Elemental Impurities Laboratory Preparation Guide.

Our UPDATED primer provides:

  • All ICH and USP harmonized guidelines
  • Guidance on how to perform elemental impurities analysis including sample preparation, instrument analysis, qualification and validation tips & tricks
  • Useful additional technical resources, webinars and videos

Our NEW laboratory preparation guide provides:

  • Parts for laboratory equipment, consumables and standards for analysis of elemental impurities
QC Primer and Laboratory Preparation Guide for USP 232, 233, 2232 and ICH Q3D Request

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