FTIR laboratory: identifying critical pharmaceutical residues

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Securing the identification of critical pharmaceutical residues

In the pharmaceutical industry, the presence of organic, inorganic, or particulate residues can compromise regulatory compliance, product quality, and process control. The issues notably concern elemental impurities according to ICH Q3D, cleaning residues, mineral acids, total hydrocarbons, total organic carbon, extractables and leachables, as well as visible or subvisible particles. A suitable analytical strategy makes it possible to quickly direct root-cause investigations, assess material risk, document a deviation, and make quality decisions more reliable.

Targeting organic, inorganic, and particulate residues

Investigations may focus on organic residues such as total hydrocarbons, residual solvents, additives, volatile, semi-volatile, and non-volatile compounds, as well as total organic carbon. They also cover inorganic residues: heavy metals, elemental impurities, cleaning residues, and mineral acids. Finally, particulate residues are studied to document their morphology, composition, and potential impact on the product or process.

Developing, validating, and interpreting analytical methods

Au-delà de l’essai, le laboratoire accompagne les industriels dans le développement de méthode, la validation analytique selon l’ICH Q2 ou l’USP <233>, l’investigation de non-conformité, les études de stabilité et de dégradation forcée, ainsi que les problématiques d’extractibles et relargables. Cette expertise est particulièrement utile lorsque la matrice est complexe, que les niveaux recherchés sont faibles ou que la méthode doit être adaptée à un produit spécifique.

Benefit from a multi-technique analytical platform

Filab has a high-level analytical platform bringing together FTIR, HPLC-MS/MS, HRMS, HPLC-HRMS/MS, SEC, IEX-UV, ICP, DSC, and microscopy. This complementarity makes it possible to quickly cross-check data to identify an unknown residue, confirm a hypothesis, or distinguish between several possible sources of contamination. The laboratory works on formulation issues, supplier qualification, reverse engineering, material anomalies, and contamination control.

Rely on a laboratory equipped for residue identification

The laboratory uses a multi-technique approach to characterize critical residues in complex pharmaceutical matrices. This approach combines FTIR analysis, chromatography, mass spectrometry, ICP, microscopy, and measurements dedicated to organic, inorganic, and particulate contaminants. The goal is to identify the nature of the residue, estimate its content when necessary, and connect the result to your industrial issue: anomaly investigation, supplier qualification, cleaning validation, extractables and leachables studies, analytical development, or regulatory support.

Using the right techniques for each contaminant family

For organic compounds, the laboratory relies in particular on GC-FID according to NF EN ISO 9377-2, TOC measurement according to NF EN 1484, Hs Gc Ms Laboratory Analysis, GC/MS, and LC-HRMS. For trace elements and metals, it deploys ICP-AES, ICP-MS, and ICP-MS/MS, in line with the expectations of ICP analysis in pharmaceuticals. For particles, optical microscopy, the Meb Analysis Laboratory, and the Met Analysis Laboratory help refine interpretation.

Supporting quality, R&D, and compliance projects

Examples of support include setting up methods to quantify the 24 elemental impurities according to ICH Q3D in a drug, identifying impurities by ICP-MS/MS, measuring elemental impurities in gels, as well as migration studies related to containers and production systems. This integrated approach provides analytical results as well as a technical interpretation that your QA, QC, regulatory affairs, and development teams can use.

Choose a quality partner for pharmaceutical challenges

Le laboratoire s’appuie sur une organisation qualité reconnue, avec accréditation ISO 17025 par le COFRAC sur des activités en produits cosmétiques et pharmaceutiques, et sur une expertise mobilisable pour des projets exigeants. Les analyses peuvent être structurées selon des référentiels tels que l’ICH Q3D, l’USP <233>, l’ISO 10993-12, l’ASTM G 136-03, l’AAMI TIR42, l’USP 788 ou la PE 2.9.19. Pour des besoins connexes, une orientation vers des approches comme le Laboratoire Analyse Iso 21392 peut également enrichir la stratégie de caractérisation.

Define, submit, analyze, interpret

To begin a study, it is necessary to specify the matrix, the context of the anomaly or control, the suspected contaminants, the level of urgency, and the reference standards targeted. The laboratory can then propose a tailored analytical strategy, from initial screening to in-depth identification and, if needed, quantification and method validation. To move forward efficiently: define the need, provide the relevant process information, have the samples analyzed, interpret the results with the experts, secure quality decisions.

Frequently asked questions

How can critical pharmaceutical residues be identified in a drug, device, or contact material?

L’identification de résidus pharmaceutiques critiques repose sur une combinaison de techniques analytiques choisies selon la nature présumée du contaminant. Les résidus organiques peuvent être investigués par analyse IRTF, GC-FID, HS-GC/MS, GC/MS, LC-HRMS ou HPLC-MS/MS. Les résidus inorganiques sont caractérisés par ICP-AES, ICP-MS ou ICP-MS/MS, notamment pour les impuretés élémentaires visées par l’ICH Q3D et l’USP <233>. Les résidus particulaires peuvent être observés et comptés par microscopie optique, MEB-EDX ou autres approches de caractérisation. Cette logique analytique permet d’identifier l’origine probable du résidu et de fournir des données exploitables pour la qualité, la production et la R&D.

What types of critical residues can you look for in the pharmaceutical industry?

The laboratory can search for organic, inorganic, and particulate residues in products, raw materials, containers, devices, and contact materials. This includes total hydrocarbons, TOC, residual solvents, organic additives, elemental impurities from classes 1, 2, 2b, and 3, heavy metals, cleaning residues, mineral acids, as well as particles according to the applicable standards. The testing strategy is defined according to your matrix, process history, and quality or regulatory objective.

What expertise does the laboratory offer beyond one-off analysis?

Yes. The laboratory also provides method development and validation, investigation support, material characterization, extractables and leachables studies, and regulatory support. This capability is essential when residues must not only be detected, but also understood, quantified, and linked to a material, process, or use-condition cause.

Why entrust this critical residue investigation to Filab?

Choosing Filab means relying on a laboratory capable of combining pharmaceutical expertise, complementary analytical resources, and methodological support. This combination makes it possible to accelerate the identification of critical residues, improve the reliability of interpretation, and produce data aligned with quality, industrial, and regulatory requirements.

How do you start a study to identify critical pharmaceutical residues?

To launch your project, simply formalize your analytical need and share the available information about the product, the process, and the nonconformity observed. A suitable testing strategy can then be proposed to identify critical residues, understand their likely origin, and guide corrective actions or compliance efforts.