Analysis according to ICH Q3D guideline: elemental impurities

The 6NAPSE Group carries out the analysis of elemental impurities in pharmaceutical products according to the ICH Q3D / USP 233 guideline.

During the synthesis of a pharmaceutical product, elemental impurities may be present. They come from different sources, residual catalysts, interactions with processing equipment, etc.

Quality control and verification of heavy metal levels are essential for pharmaceutical laboratories, whatever the product and its route of administration (oral, inhalation, etc.).

Published in December 2014 and applicable since December 1, 2018, the ICH Q3D guideline establishes a protocol for controlling elemental impurities in pharmaceutical products based on 3 different steps:

Evaluation of toxicological data of elemental impurities
Determination of daily exposure value
Analyze the risk

ICH Q3D analysis of pharmaceuticals and drugs

The 6NAPSE Group performs the quantification of elemental impurities within your pharmaceutical products.

Our analytical park makes it possible to meet ICH Q3D / USP 233 regulations (analysis by ICP-AES, analysis by ICP-MS, mineralization methodologies, etc.).

We can support you in quality control but also in analytical development in the laboratory. Our experience in the dosage of elemental impurities and heavy metals allows us to advise you in this process of validation of raw materials and finished products.

Chemical analysis by ICP-MS or by ICP-AES in laboratory
Dosage of residual solvents according to ICH Q3D
Analysis of heavy metals
Analysis of elemental impurities ICH Q3D
Analytical validation according to USP 233
Control and analysis of the risk of contamination
Expertise for the pharmaceutical industry

Directive ICH Q3D pour les produits pharmaceutiques

The directive defines the permissible daily exposure values (PDEs) for each element according to 3 groups:

Group 1: As, Cd, Hg and Pb
Group 2A: Co, Ni and V
Group 2B: Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, Tl
Group 3: Al, B, Ca, Fe, K, Mg, Na, W and Zn

USP 233 (elemental impurities – procedures) recommends the use of ICP-AES (Inductively Coupled Plasma Optical Emission Spectrometry) and ICP-MS (Inductively Coupled Plasma Mass Spectrometry).
USP 232 further defines the content limits for elemental impurities in drugs (As, Cd, Hg, Pb, Co, Ni, V, Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, Tl, Ba, Cr, Cu, Li, Mo, Sb, Sn).

Short standard deadlines and possibilities of emergencies.

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