Analytical Laboratory Serving the Pharmaceutical Industry
Chemical and Materials Analysis and Expertise Serving the Pharmaceutical Industry
The pharmaceutical sector is a world of its own, with its own rules and codes. FILAB’s laboratory fully understands this exceptional dimension. Our PhD scientists and engineers are therefore trained to meet your specific pharmaceutical analysis needs, thanks to our expertise in the pharmaceutical industry,
such as:- Setting up an analysis method specific to your products, validated according to the ICH Q2 guideline
- Identifying an impurity or particle
- Investigating an issue with the behavior of one of your products (degradation, color change, odor, etc.)
- Deformation of an API or an existing product
From the development of new dosage forms to the control of your production, FILAB laboratory offers you high-level human expertise and state-of-the-art analytical equipment to provide tailor-made services, all within a quality environment meeting GMP criteria.
FILAB carries out analysis and expert assessments for the pharmaceutical industry
As an extension of your in-house laboratories, the laboratory offers pharmaceutical manufacturers the following services:
Our quality control analysis for the pharmaceutical industry
Nitrosamines are classified by the IARC and the WHO as harmful compounds and are considered potentially carcinogenic to humans. In addition, the ANSM closely monitors them.
Le guide ICH Q3D établit la procédure pour évaluer les impuretés élémentaires dans les produits pharmaceutiques, y compris ceux destinés à l'humain
ICH Q3C provides guidance on acceptable toxicological thresholds for patient safety regarding 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 particle size, shape, and distribution, which is particularly important for the pharmaceutical industry in controlling contamination in powders and injectable products.
FILAB laboratory follows the ICH Q3E guideline.
- Identification of extractables according to USP <1663>
- Identification of leachables according to USP <1664>
- Extractables & Leachables analysis according to BPOG (Good Operating Practices)
- Plastic packaging analysis according to USP <665> and USP <1665>
- Analysis of plastic material components according to USP <661.1>
- Packaging analysis and verification: interactions with the drug according to USP <661.2>
A forced degradation study tests the stability of pharmaceutical products/APIs to assess their behavior, purity, and compliance over time.
The ICH Q2 guideline guides the validation of analytical methods, developed by ICH experts and submitted to regulatory consultations.
Filab supports you with training in analytical method validation for your teams
The FILAB laboratory is notably the only laboratory in France accredited ISO 17025 by COFRAC (www.cofrac.fr: accreditation no. 1-1793) for elemental impurity analysis in pharmaceutical matrices.
Our techniques
Organic chemical analysis
GC/MS, Py-GCMS, UPLC-MSMS, LC-QTOF-MS, LC-QTOF-MS, LC-ORBITRAP, GPC, NMR, FTIR
Powder analysis
XRD, SEM-FEG EDX, BET, Laser particle size analysis
Inorganic chemical analysis
ICP, DRX, CI
Thermal analysis
ATG, ATG-FTIR, DSC
Surface characterization
SEM-FEG EDX, XPS, TOF-SIMS
Our FAQ
As a pharmaceutical testing laboratory, we carry out analyses to ensure the safety, efficacy, and quality of pharmaceutical products. These analyses cover a wide range of aspects, from raw material characterization to finished product evaluation, including stability studies.
Here are some examples of commonly performed analyses:
- Physicochemical Analysis and Chemical Analyses: Includes the determination of purity, chemical structure, solubility, pH, viscosity, and surface tension of substances. These analyses make it possible to characterize 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 spectrometry (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.
- Drug Stability Tests: Evaluate how the quality of a drug changes over time under the influence of environmental factors such as temperature, humidity, and light. These tests are essential for determining product shelf life.
- Pharmaceutical Quality Control: Covers all the previous tests to ensure that finished products meet regulatory standards and internal specifications before being placed on the market.
These analyses are fundamental to new drug development, quality assurance, and regulatory compliance, ensuring that pharmaceutical products are safe and effective for use.
Catalyst analysis: vis intended to characterize the catalysts used in pharmaceutical synthesis processes. It makes it possible to analyze the chemical composition, the state of the active phases, the specific surface area, and the dispersion of catalytic sites in order to ensure the efficiency, reproducibility, and control of chemical reactions.
Extractables & Leachables analysis make it possible to identify substances likely to migrate from materials, packaging, or equipment into a medicine. They help control contamination risks, ensure patient safety, and meet regulatory requirements.
USP <1663> concerns the identification of extractables, meaning compounds that may be released under forced conditions. USP <1664> focuses on leachables, corresponding to substances actually transferred to the pharmaceutical product under its normal conditions of use or storage.
E&L studies rely on several recognized standards such as ICH Q3E, USP <1663>, USP <1664>, as well as BPOG recommendations, in order to assess the risks associated with materials in contact with pharmaceutical products.
The choice of an E&L laboratory should be based on several criteria: mastery of regulatory frameworks (ICH Q3E, USP <1663>, USP <1664>, USP <661>, USP <665>), expertise in materials characterization, advanced analytical capabilities (GC-MS, LC-MS, ICP-MS), and support with pharmaceutical compliance challenges.
Specialist in chemical and materials analysis, FILAB supports pharmaceutical manufacturers in their extractables and leachables studies. The laboratory carries out analysis in particular according to USP <1663>, USP <1664>, BPOG, USP <661.1> / <661.2>, USP <665> / <1665>, in compliance with the ICH Q3E guideline. FILAB relies on a multi-technique analytical platform, COFRAC ISO 17025 accreditation, and recognized expertise in chemistry and materials characterization.
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