Method validation according to EP 2.4.20 - FILAB
Analysis and expertise laboratory

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 filab advantages
A highly qualified team
A highly qualified team
Responsiveness in responding to and processing requests
Responsiveness in responding to and processing requests
A COFRAC ISO 17025 accredited laboratory
A COFRAC ISO 17025 accredited laboratory
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
A complete analytical park of 5,200m²
A complete analytical park of 5,200m²
Tailor-made support
Tailor-made support
Benoît PERSIN Sales Manager
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