Pharmaceutical materials analysis laboratory: impurities and leachables

Active substances, excipients, packaging components, devices and production equipment can introduce impurities or extractable and leachable compounds into a medicinal product. Their identification, assessment and quantification are essential for documenting product quality, investigating an analytical deviation or securing a material change. Filab laboratory supports Pharmaceutical manufacturers with their pharmaceutical materials analysis and impurities and leachables analysis studies, from defining the requirements through to interpreting the results. Investigations may notably form part of an elemental impurities assessment, alongside an ICP analysis for pharmaceutical applications suited to the matrices concerned.

Studies may concern polymeric materials, elastomers, glass, metals, coatings, adhesives, inks and multilayer systems found in packaging components, drug delivery devices or manufacturing equipment. The components of a stopper, syringe, vial, bag or transfer line can be assessed according to their contact with the pharmaceutical formulation.

Identifying an unknown impurity relies on a progressive analytical approach: sample observation, suitable preparation, screening and confirmation using complementary methods. Chromatographic techniques coupled with mass spectrometry can be used to investigate numerous organic compounds. Elemental analysis provide information on metals and other inorganic elements.

A study may be initiated during the development of a new formulation or new packaging, supplier qualification, a raw material change, a process modification or the introduction of new equipment. It also addresses investigation needs following the detection of an unexpected peak, particle, discoloration, deposit or non-conformity.

At Filab laboratory, the analytical strategy is defined according to the material, the product in contact with it, the identified risk and the study objective: screening, identification, targeted quantification, batch comparison or root-cause investigation. The approaches combine separation, spectrometric and materials analysis techniques to characterize organic compounds, trace elements and particles. Services may include support for ICH Q3D analysis relating to elemental impurities, as well as the characterization of materials and defects by TEM analysis.

The investigation may cover volatile, semi-volatile or non-volatile compounds, as well as metallic elements. The protocol takes solvents, temperature conditions, contact time and the intended use scenario into account. The results make it possible to compare materials, target substances of interest and support container-closure and product compatibility assessments.

In the presence of particles, deposits, inclusions or surface defects, Filab laboratory can use scanning electron microscopy with EDX microanalysis. This approach helps determine the morphology and elemental composition of a contaminant. The thermal properties of certain materials can also be studied by TGA analysis to assist with their characterization.

Filab laboratory adapts the level of investigation to the need: initial characterization, before-and-after comparison following a change, targeted screening for a compound, quantification, or migration study. Analytical data are delivered in an actionable format to support a risk assessment, a material selection decision, or a quality investigation.

To get started, provide Filab laboratory with the available information on the product, materials, contact conditions, observed phenomenon, and expected objective. The teams can then define the scope of testing, the samples to be provided, the techniques to be used, and the expected deliverables. Contact Filab laboratory, present your issue and receive an analysis proposal tailored to your pharmaceutical project.