Detecting and identifying impurity

Your needs : to identify and characterize an impurity found in a material or in a formulation

The behavior of an industrial substance is directly linked to the characteristics and the purity of the materials used to produce it. In light of this, monitoring the conformity of the materials being used is a key step of the production process.

The presence of particulate matter, of an unknown deposit, the appearance of unknown spikes, etc. These represent cases of non-conformities which can stop a product from going on the market. For this reason, industrialists regularly call on analytical laboratories to identify and characterize any impurities found to be in their materials or formulations.  

Our solution : to provide you with our skills and our analytical tools, adapting them to your impurity related challenges.

With an analytical fleet spread over 2100m² and a team made up of doctors and engineers, FILAB can assist industrialists in detecting and identifying impurities in their products.

To overcome these challenges with precise and reliable results, FILAB offers a wide range of analytical techniques, adapted to all types of materials :

Detecting and identifying impurities using a Scanning Electron Microscope coupled to an EDX probe :

Detecting and identifying impurities using ICP-AES, ICP-MS and ISP-SEO

Detecting and identifying impurities using GC-FID, GCMS and UPLC MS/MS :

Detecting and identifying impurities using NMR :

  • Analysis of active ingredients

  • Measurement of enantiomeric excess

  • Measurement of optical purity

Detecting and identifying impurities in accordance with the European Pharmacopoeia :

  • Analysis and determination of heavy metals

  • Analysis of active ingredients

FILAB detects and identifies impurities in accordance with the relevant regulations :

FILAB has been CIR (Crédit Impôt Recherche) approved to be able to provide the best possible assistance.

With three levels of services – analysis, expertise and R&D support – FILAB assists companies from all sectors and of all sizes in overcoming their industrial challenges by sharing its technical know-how and the wealth of experience of its team with its clients.

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Impurity analysis is a crucial step in the development and manufacturing process of any material or formulation. Impurities can be present at different levels and can come from different sources, such as raw materials, reagents, solvents, water, production environment... These impurities can affect the quality, safety and efficiency of the final product.

Impurity analysis is used to detect and quantify impurities in a material or formulation. The results of this analysis can be used to determine whether the levels of impurities are within regulatory and quality control standards, and whether they are acceptable for the safe and effective use of the product.

Impurity analysis is essential to ensure the quality and safety of pharmaceutical, cosmetic, food and other products. It is also important for optimising manufacturing processes and minimising the risk of cross-contamination during production.

In impurity analysis, elemental impurities are substances that contain chemical elements different from those present in the main substance. These impurities may be introduced into a material or formulation from the raw materials or reagents used in the manufacturing process. Elemental impurities may be present in trace amounts, but they can have a significant impact on the quality and performance of the final product.

Elemental impurity analysis is a commonly used technique for quantifying foreign elements in a material or formulation. This analysis can be performed using techniques such as atomic emission spectroscopy, mass spectroscopy, ion chromatography, X-ray fluorescence, etc. The results of this analysis are used to determine the quantity and nature of the elements present in the material or formulation, and to check whether they comply with regulatory and quality control specifications.

There are several regulations in place regarding impurity analysis, depending on the industry and country. Some examples are listed below:

Pharmaceutical industries: European Medicines Agency (EMA) and US Food and Drug Administration (FDA) regulations require drug manufacturers to perform impurity testing to ensure that impurity levels in finished products meet regulatory specifications. International Standards Organisation (ISO) standards are also used to ensure the quality and safety of pharmaceutical products.
Cosmetic industries: European Union (EU) and FDA regulations require cosmetic manufacturers to perform impurity testing to ensure that finished products are free of contaminants and substances harmful to the skin.
Chemical industries: EU and US government regulations require chemical manufacturers to perform impurity testing to ensure that they do not contain substances that are hazardous to the environment or human health.

Eve BALEY Technical Sales Representative
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