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Analytical development, transfer, and validation of new methods :
Characterizing a product or a biproduct, quantifying an impurity or a pollutant in a finished product or on the surface of a material, inspecting the purity and the stability of a compound… These are all challenges which call for the development and optimization of innovative and efficient analytical methods.
However, in order to confirm its efficiency and characteristics, the new method must first be tested following relevant standards.
The main factors to be taken into account when validating an analytical method are as follows : the specificity, repeatability, reproducibility, linearity and the detection capacity (LoD and LoQ).
– Specificity allows us to be sure that the signal being measured corresponds with the target analyte.
– Repeatability defines the reliability of the analysis. This concept expresses the capacity to which a test can be repeated in the same conditions and by the same person over a short period of time.
– Reproducibility is confirmed once an analysis has been performed by different people.
– Linearity is a decisive factor in determining the possibility of a system having a response resembling a line. This also determines the circumstances in which the method can be used.
– Detection capacity is defined by the Limit of detection (LoD), a value below which the analyte can no longer be detected, and the Limit of Quantification (LoQ), a value below which the analyte can no longer be quantified.
Analytical methods can be developed and validated following different standards such as COFRAC’s criteria which are based on AFNOR standards, ICH guidelines, VICH guidelines… to meet demands from different activity sectors (pharmaceuticals, veterinarian services, materials, chemistry, polymers, metallurgy, cosmetics…). FILAB has the necessary skills and high-level analytical equipment to provide analytical development and validation services using GCMS, ICP, XRD, FTIR, DSC, IC… Relying on experience and an innovative analytical fleet, FILAB compares your challenges to the characteristics of the proposed analytical method to ensure that your needs for development and validation are met.
For more information, please contact one our experts via email at firstname.lastname@example.org or over the phone : +33(0)3 80 52 32 05