Method validation according to EP 2.4.20

You want to validate your analytical methods according to EP 2.4.20?

Method validation is an essential step in confirming by examination and providing objective evidence that the method used is suitable.

In the context of PE 2.4.20, you are looking to analyze metal residues from catalysts or reagents in pharmaceutical products

In addition, as of January 2018, the guidelines set forth in the ICH Q3D: Elemental Impurities guideline became applicable to all human drugs on the market.  In addition, analytical methods can be developed using the general chapter Determination of Residues of Catalysts or Metal Reagents 2.4.20 (Figure 8: Extract from Ph. Eur. 8th Edition – Volume I).

Our solutions: provide you with our skills in method validation according to the PE 2.4.20 standard

For more than 30 years, our FILAB laboratory has had the experience and specific analytical equipment to support companies in the water sector in accordance with the PE 2.4.20 standard.

In addition, a wide range of analytical services and method validation is offered by FILAB laboratory:

  • Residual solvent analysis ICH Q3C

  • Analytical validation according to ICH Q2

  • Method validation according to USP 1225

  • Method validation according to SANCO 30/30

  • Elemental impurity analysis ICH Q3D

  • Method validation according to NF T90-210

  • Method validation according to ANVISA

  • Validation de méthodes pour l'industrie pharmaceutique

FILAB also supports you in providing remote method validation management services according to EP 2.4.20, and in training your teams in method validation according to EP 2.4.20.

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Benoît PERSIN Sales Manager
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