Analytical laboratory serving the Pharmaceutical Industry
Analysis and expertise in chemistry and materials for the pharmaceutical industry
The pharmaceutical sector is a world unto itself, with its own rules and codes. The FILAB laboratory fully understands this exceptional dimension. Our PhD students and engineers are trained to meet your specific pharmaceutical analysis needs thanks to their expertise in the pharmaceutical industry:
- Implementation of an analysis method specific to your products, validated according to ICH Q2 standards
- Identification of impurities or particles
- Problems with the behaviour of one of your products (degradation, colour change, odour, etc.)
- Deformation of an API or existing product
From the development of new galenic formulas to production control, the FILAB laboratory offers you high-level human skills and state-of-the-art analytical equipment to provide you with tailor-made services in a quality environment that meets GMP criteria.
FILAB carries out analyses and expert reports for the pharmaceutical industry
As an extension of your in-house laboratories, the laboratory offers pharmaceutical manufacturers the following services:
Our control analyses for the pharmaceutical industry
Nitrosamines are classified by the IARC and the WHO as harmful compounds that can cause cancer in humans. They are also being closely monitored by ANSM.
The ICH Q3D guide sets out the procedure for assessing elemental impurities in pharmaceutical products, including those intended for human use.
The ICH Q3C guideline provides guidance on toxicologically acceptable thresholds for patient safety with regard to concentrations of residual solvents (or residual volatile impurities) in pharmaceutical products.
Our expertise and R&D support
Particle counting is a crucial method for measuring and quantifying contaminants in various media, such as air, water and raw materials, and is vital in many scientific and industrial sectors. This technique provides detailed information on the size, shape and distribution of particles, which is particularly important for the pharmaceutical industry in monitoring the contamination of powders and injectable products.
Analysis of extractables and leachables is used to check the compliance of health products, assessing the risk of substances migrating from packaging.
A forced degradation study tests the stability of pharmaceutical products/APIs to assess their behaviour, purity and compliance over time.
The ICH Q2 guideline guides the validation of analysis methods, drawn up by ICH experts and subject to regulatory consultation.
In particular, FILAB is the only laboratory in France accredited to ISO 17025 by COFRAC (www.cofrac.fr: accreditation no. 1-1793) for the analysis of elemental impurities in pharmaceutical matrices.
Our techniques
Organic chemical analysis
GC/MS, Py-GCMS, UPLC-MSMS, LC-QTOF-MS, LC-QTOF-MS, LC-ORBITRAP, GPC, RMN, IRTF
Powder analysis
XRD, SEM-FEG EDX, BET, Laser Granulometry
Mineral chemical analysis
ICP, DRX, CI
Thermal analysis
ATG, ATG-FTIR, DSC
Surface characterisation
MEB-FEG EDX, XPS, TOF-SIMS
Our FAQs
As a pharmaceutical analysis laboratory, we carry out analyses to guarantee the safety, efficacy and quality of pharmaceutical products. These analyses cover various aspects, from the characterisation of raw materials to the assessment of finished products, including stability studies.
Here are some examples of analyses commonly carried out:
- Physico-chemical analysis and chemical analysis: This includes determining the purity, chemical structure, solubility, pH, viscosity and surface tension of substances. These analyses are used to characterise the physical and chemical properties of compounds.
- Chromatographic analysis: Techniques such as high-performance liquid chromatography (HPLC) and gas chromatography (GC) are used to separate, identify and quantify the components of a mixture.
- Spectroscopy: Includes techniques such as infrared spectroscopy (IR), mass spectroscopy (MS), and nuclear magnetic resonance (NMR), used to study the molecular structure of compounds.
- Drug dissolution tests: Measure the rate at which a drug dissolves in liquids that simulate body fluids, which is crucial for assessing its efficacy and bioavailability.
These analyses are fundamental to the development of new medicines, quality assurance and regulatory compliance, ensuring that pharmaceutical products are safe and effective for consumption.
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