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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 20 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
Caroline KURZAWA
R&D Project Engineer
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