LCMS laboratory: method development and validation

The development of an analytical method addresses the challenges of assaying, characterizing and ensuring the compliance of your products. Complex matrices, low concentrations, interferences, unknown impurities or regulated substances require an analytical strategy designed around your needs. Filab laboratory develops methods using LC-MS/MS, LC-QTOF and complementary chromatographic techniques to screen for, identify and quantify target compounds. This service may cover active ingredient assays, impurity screening, monitoring degradation products and stability testing.

Filab laboratory has analytical development capabilities suited to a wide range of needs: LC-UV, LC-MS/MS, LC-QTOF/MS, LC-RI, LC-CAD, LC-ELSD, GC-MS, GC-FID, HS-GC-MS, ICP-AES, ICP-MS, ICP-MS/MS and ion chromatography. These technologies make it possible to select the most relevant detection mode according to the physicochemical properties of the compounds, the matrix and the analytical thresholds to be achieved.

Validation is designed according to the method’s purpose: control of an active ingredient, impurity monitoring, quantification of residual substances, stability testing or investigation. Filab laboratory assesses the necessary criteria, including selectivity, linearity, precision, accuracy, sensitivity, limits of detection and quantification, and robustness.

Filab laboratory supports industrial companies in defining their needs, conducting feasibility studies, selecting techniques, and developing, optimizing and validating methods. Outsourcing makes it possible to access diversified analytical capabilities while allowing your teams to focus on their priority activities. Method development training can also support the upskilling of your teams.

Method validation demonstrates that the developed method is suitable for its intended use. At Filab laboratory, the protocol is defined according to your analytical objective and the expected performance: specificity, linearity, precision, accuracy, limits of detection and quantification, working range and robustness. Tests are conducted on your matrix, analytes and concentration levels to provide actionable results for your R&D, quality control or investigation activities.

LC-MS is particularly suitable for compounds that are poorly volatile, polar or present at trace levels. For volatile or semi-volatile analytes, Filab laboratory can also perform HS-GC-MS analysis. Combining orthogonal techniques can help secure compound identification and improve understanding of an analytical issue.

Test conditions, results and their interpretation are recorded in documentation tailored to the project. For issues involving impurities and residual compounds, discover the support provided by the analytical method validation testing laboratory for impurities and residual substances.

Filab laboratory is accredited by COFRAC under no. 1-1793, with its scope available on the COFRAC website, and is recognized under the Research Tax Credit scheme. Projects are conducted with close attention to test traceability, result consistency and their suitability for your industrial decision-making. In addition, an industrial process audit can help link analytical results to manufacturing parameters.

To start your project, provide the available information about the matrix, compounds of interest, expected concentrations, specifications, and final objective. Contacting the Filab laboratory helps define the technical scope, assess feasibility, and develop a tailored proposal. Describe your requirements, send your samples, and request a technical discussion to begin your method development and validation.