LC-MS laboratory: measuring contaminants and leachables

Substances not intentionally added may migrate from a material, packaging, device or manufacturing equipment into the finished product. Additives, degradation products, synthesis residues, monomers, oligomers, surfactants or compounds resulting from ageing may constitute contaminants and leachables that need to be characterised. Filab laboratory supports manufacturers in implementing an analytical strategy suited to development, quality control, compliance and investigation requirements.

Filab laboratory uses targeted methods to measure the analytes specified in your requirements: additives, antioxidants, plasticisers, manufacturing residues, degradation products, surfactants or molecules originating from a formulation. This approach provides quantitative results when the substances, standards and analytical conditions have been established. It can be supplemented by specific analysis, such as an analysis according to USP <661>, depending on the project context.

An extractables study evaluates substances that may be extracted from a material under defined conditions, often using solvents and exaggerated conditions. It establishes a profile of potentially mobilisable compounds and helps guide risk assessment and the selection of substances to monitor.

Filab laboratory studies polymer materials, packaging, parts, coatings, adhesives, inks, lubricants, powders and industrial preparations. Analytical feasibility is assessed according to the nature of the matrix, the substances likely to be present and the expected performance. Targeted analysis can also address specific issues, such as chlorinated paraffin measurement.

An LC-MS analysis makes it possible to separate and then detect organic compounds that are low-volatility, heat-sensitive or present at trace levels. Depending on the requirement, Filab laboratory uses a targeted approach to quantify identified substances, or a screening process to investigate unknown compounds. Sample preparation, extraction conditions, the choice of standards and the quantification level are defined according to the matrix, expected concentrations and project acceptance criteria.

When no substance list is available, LC-MS screening can detect characteristic chromatographic and mass signals. Compounds of interest are then prioritised according to their abundance, profile and relevance to the matrix under investigation. Additional analysis may be proposed to confirm identification and determine whether quantification is required.

A leachables study focuses on substances actually transferred from the material into the product or contact medium under conditions representative of use, storage or ageing. The analytical strategy takes into account contact time, temperature, the nature of the medium and decision thresholds. For volatile compounds, HS-GC-MS analysis can supplement the LC-MS approach.

analysis may focus on the finished product, an extract prepared according to a defined protocol or a medium that has been in contact with the material. Filab laboratory supports the definition of the sampling plan, extraction conditions and controls required to obtain interpretable data. Results are reported with the units, limits and analytical information needed for decision-making.

Send Filab laboratory a description of the product, material and its intended use; specify the substances being sought or the need for screening; indicate the contact conditions, expected concentrations and applicable requirements; provide representative samples and, where necessary, controls. Filab laboratory will propose a strategy including LC-MS analysis, any complementary techniques, turnaround times and reporting methods. Contact Filab laboratory to define your contaminant and leachable testing study.