LCMS laboratory: method development and validation

Characterizing, assaying or monitoring impurities in complex matrices requires a selective, sensitive and reproducible analytical method. When the existing method does not cover your matrix, concentration levels or compounds of interest, a tailored development and method validation becomes necessary. The Filab laboratory supports industrial companies in defining an LC-MS analysis strategy consistent with their R&D, quality control, investigation or batch comparison objectives.

The strategy is developed according to the purpose of the analysis: identification, quantification, profiling or targeted research. The Filab laboratory can assess extraction, dilution, purification and sample storage conditions before analysis. The approach is intended in particular to limit matrix effects and ensure reliable analytical response under the intended conditions of use.

Liquid chromatography coupled with mass spectrometry separates compounds present in a mixture and then detects them according to their mass-to-charge ratio. When a high level of selectivity is required or concentrations are low, an LC-MS/MS approach can provide additional information to target and confirm the compounds of interest. The choice of approach is determined with regard to the matrix, analytes and analytical objective.

At the end of the work, the Filab laboratory reports the results obtained, the analytical conditions selected and the data related to the validation tests performed. This documentation provides an understanding of the method’s field of application, performance and any limitations identified. Discussions with your teams facilitate the use of the results in your technical decisions.

At the Filab laboratory, the development of a method using an LCMS laboratory begins with an assessment of your needs: matrix type, target analytes, expected levels, sample preparation constraints and decision criteria. Chromatographic and mass spectrometry parameters are then adjusted to obtain relevant separation, suitable detection and interpretable results. The method is documented at every stage to support its implementation and potential transfer.

The validation scope is defined according to the intended use of the method and your internal requirements. It may include the assessment of selectivity, linearity, precision, trueness, limits of detection and quantification, as well as robustness. The results make it possible to assess the method’s ability to produce reliable data within its field of application.

Industrial products may have heterogeneous formulations, variable contents and analytical interferences. The Filab laboratory adapts sample preparation and analytical conditions to these constraints: raw materials, manufacturing intermediates, finished products, extracts or solutions. For issues relating to extractables and leachables, discover the USP 661 analytical laboratory.

The development and validation of methods is frequently part of a broader approach to product qualification, process optimization, or the resolution of non-conformities. Filab laboratory can help structure your analytical requirements, complementing an industrial process audit. Research projects can also be carried out with the support of a CIR-accredited laboratory.

To initiate your project, provide the available information about your samples, the compounds being sought, the expected concentrations, and the desired timeframe. Filab laboratory can define the analytical scope and propose a suitable approach. Describe your requirements, send your samples, and request a technical discussion with our teams.