LCMS Laboratory: develop and validate your industrial methods

Bringing a new product to market, changing a process, or managing a non-conformity all require reliable, robust analytical methods adapted to the matrix being studied. An LCMS laboratory supports industrial companies in the industrial methods development and industrial methods validation for the assay of active ingredients, impurity screening, stability testing, contaminant identification, and regulatory monitoring. The challenge is to have a specific, sensitive, and transferable method capable of meeting quality, R&D, and production requirements. To learn more about this expertise, discover our Analytical Development Validation Laboratory.

Depending on the nature of your product and the compounds being sought, the laboratory can rely on liquid chromatography LC-UV, LC-MS/MS, LC-QTOF/MS, LC-RI, LC-CAD or LC-ELSD, as well as gas chromatography GC-MS, GC-FID and HS-GCMS, ICP-AES, ICP-MS and ICP-MS/MS, as well as ion chromatography. This complementarity makes it possible to address a wide range of issues: organic compounds, residual solvents, elemental impurities, ionic species, regulated substances, or degradation products. For volatile and semi-volatile compounds, also see our page Laboratory GC MS Analysis.

Validation of an analytical method is carried out according to the product context and the applicable regulatory framework. An expert laboratory can perform validations according to ICH Q2, USP 233, ICH Q3D, ISO 19227, ISO 10993 or NF ISO 13779-3 when relevant. The goal is to demonstrate that the method is fit for its intended use, whether for release testing, stability studies, biocompatibility assessment, cleaning monitoring, or process qualification.

Outsourcing speeds up development phases, reduces the workload on your internal teams, and gives you rapid access to state-of-the-art equipment without additional investment. It also makes it easier to manage one-off or complex issues: non-conformity, formulation changes, process evolution, regulatory validation needs, or industrial scale-up. In some cases, complementary characterization techniques may be useful, such as surface analysis or material observation via Laboratory SEM Analysis.

Outsourcing the management of your analytical methods saves time, improves result reliability, and quickly mobilizes advanced technical expertise. An independent laboratory can handle the different stages of the project: needs assessment, technique selection, feasibility testing, parameter optimization, validation according to applicable standards, and support for method transfer on site. This approach is particularly useful for R&D projects, process optimization, raw material qualification, finished product testing, and regulatory assessment.

The methods developed can meet needs for quantification, identification, impurity profiling, purity testing, stability studies, cleaning residue analysis, process validation, or failure investigation. The laboratory works on a wide variety of matrices: raw materials, treatment baths, gels, medical devices, metal materials, technical powders, chemical formulations, cosmetic products, or pharmaceutical products. For issues related to metals and trace elements, also see Met Analysis Laboratory.

Common cases include the quantification of the 24 elemental impurities according to ICH Q3D, impurity identification by ICP-MS/MS, the assay of heavy metals such as lead, mercury, arsenic, or cadmium, the analysis of organic and inorganic cleaning residues, and the characterization of materials and alloys. For residual solvent analysis, additional content is available via USP 467 Analysis Laboratory.

Relying on an independent laboratory accredited to ISO 17025 by COFRAC, with recognized quality and technical support capabilities, provides a reliable framework for your analytical projects. Human, instrumental, and documentary resources are mobilized according to your sector and your challenges: pharmaceuticals, cosmetics, chemistry, medical devices, metallurgy, or industrial processes. Support can range from initial scoping through to method transfer to your site.

Working with an expert laboratory is relevant as soon as an existing method is no longer suitable, a new product needs to be characterized, a regulatory requirement changes, or an analytical transfer needs to be prepared. It is also the right approach when impurity profiling, assay of regulated substances, stability testing, elemental impurity analysis, cleaning validation, or post-failure investigation is required. Defining the need, characterizing the matrix, selecting the technique, validating the method, and preparing the transfer: all steps to undertake with an experienced analytical partner.