Analysis and expertise laboratory

Method validation according to USP 1225

More than 120 people
More than 120 people at your service
5200 m² laboratory
5200 m² laboratory + 99% of services are provided in-house

Industriels du secteur pharmaceutique, vous souhaitez valider vos méthodes analytiques selon l'USP 1225

Qu'est-ce qu'une validation de méthode ?

The method validation process takes place after the development of the method. This step allows to verify the method and to make sure that it meets the expectations by respecting the targeted standards.

The validation of method evaluates various parameters in particular:

  • linearity
  • accuracy
  • fidelity
  • repeatability
  • detection limits
  • stability…

In addition, USP 1225 is a standard that concerns the validation methods of analytical procedures applied to drugs and biological products. Thus, in order to validate your analytical methods according to the USP 1225 standard, the support of a specialized laboratory is essential. 

FILAB laboratory supports you in method validation according to USP 1225

For more than 30 years, our FILAB laboratory has had the experience and specific analytical equipment to assist companies in the validation of analytical methods according to USP 1225.

In addition, FILAB also performs method validation according to various regulations and standards, including

Method validation according to ICH Q2

Method validation according to PE 2.4.20

Residual solvent analysis ICH Q3C

Method validation according to SANCO 30/30

Elemental impurity analysis ICH Q3D

Method validation according to NF T90-210

Method validation according to ANVISA

FILAB can also provide you with remote method validation services according to USP 255, as well as training for your teams in method validation according to USP 255.

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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