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What is ICH Q3D on elemental impurities?

Directive ICH Q3D aims to limit the presence of potentially toxic elemental impurities (also known as heavy metals) in pharmaceutical products intended for human use.


This directive is linked to changes in the pharmacopoeias (Ph.Eur. & USP) with the introduction of new, safer, more selective and precise analytical methods with greater reproducibility and better recovery.


Likewise the directive establishes the toxicity limits of potentially present elements.


Directive ICH Q3D sets out a list of 24 elements divided into four categories (classes 1, 2A, 2B and 3), in relation to their toxicity and their probability of occurrence and the maximum permitted daily exposure (PDE: Permitted Daily Exposure) for each impurity according to the administration route (µg / day).

Directive ICH Q3D sets out the methodology for:


  • The elements that must be taken into account.
  • The limits for each element.
  • The methodology to be followed in carrying out risk analyses.
  • Control strategies based on the values / limits obtained.


The implementation dates in Europe for this new regulation are:


Date Phase
December 2014 ICH Q3D Step 4
December 2014 Adopted by CHMP EMA/CHMP/ICH/353369/2013 (2)
June 2015 Pharmeuropa – Published list of pharmacopoeial monographs involved
June 2016 ICH Q3D applicable to new products
December 2017 ICH Q3D applicable to licensed products
In implementation phase Removal of references to monographs 2.4.8 on individual monographs


At Azierta, EUROTOX corporate members, we are experts in toxicology and ICH Q3D implementation. Our multidisciplinary team has AETOX, EUROTOX and ERT certified members. We design and develop customized action plans for the implementation of ICH Q3D of elemental impurities, with a background of more than 600 reports completed or in progress, both on a national and international basis, which have already been assessed by health authorities.

Visit our website and fill out our form to gain access to practical advice on the implementation of ICH Q3D on elemental impurities.

If you would like to know more about us, please visit: Elemental impurities risk analysis


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