Impurity analysis and testing at FILAB Laboratory
As an industrial company, you want to carry out impurity testing and identification on a material or in a formulation
Why perform an impurity analysis?
The performance of an industrial product depends on the characteristics and purity of the materials from which it is made. With this in mind, checking the conformity of the materials used is an essential step in the production process. The presence of an unknown particle, deposit, ghost peak… may constitute a non-conformity that prevents a product from being placed on the market. For this reason, industrial companies regularly call on analytical laboratories to test for and identify impurities in a material or formulation.
What does laboratory impurity analysis involve?
This analysis consists of detecting and identifying impurities present in a sample.
Impurities may include heavy metals, solvent residues, degradation products or microbial contaminants.
Impurities can come from various sources and may affect the quality and final purity of the substance under study. It is therefore essential to know how to detect, characterise and quantify them in order to obtain accurate and reliable data. It is possible to detect impurities at very low levels and obtain information about their nature and concentration in our laboratory, an expert in chemical analysis.
Why test for and identify impurities in your sample?
Testing for and identifying impurities in your sample is important. Indeed, the presence of impurities can not only affect the quality of the final product, but also the use and service life of a material.
Laboratory impurity analysis helps guarantee the quality and safety of chemical substances and materials used in various industries. Once the impurities have been identified, corrective measures can be taken to prevent future contamination.
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Our solutions: making our expertise and analytical tools available to characterise the impurities present in your products
With a state-of-the-art analytical equipment fleet, FILAB laboratory supports industrial companies in testing for and identifying impurities in their materials and formulations.
To address these issues with precision and reliability, FILAB offers a wide range of analytical techniques suitable for all types of materials:
Our impurity testing and identification services
our services
Identify the nature of a solid impurity by SEM-EDX
Impurity testing in a pharmaceutical product by analysis according to ICH Q3D
Testing for traces of undesirable substances: heavy metals, phthalates, nitrosamines...
Impurity identification by NMR analysis
Our technical resources dedicated to impurity testing and identification
Impurity analysis is a crucial step in the control and manufacture of chemical, pharmaceutical and cosmetic products. Our technical resources dedicated to impurity testing and identification include state-of-the-art equipment.
To detect these impurities, the FILAB laboratory uses analytical methods such as chromatography, mass spectrometry and microscopy.
By using these methods, the laboratory can identify the nature, quantity and origin of the impurity. By combining these different methods, our laboratory can therefore provide you with accurate data for impurity detection and quantification.
Application areas of impurity analysis
In the food and pharmaceutical industries, a variety of impurities may be found in finished products. These impurities can come from several different sources, such as environmental contamination, manufacturing practices, and raw materials. In the food sector, impurities may also come from packaging components, allergens, bacteria, pesticide residues, and artificial additives.
In the pharmaceutical industry, impurities may result from unexpected chemical reactions or even from the presence of microorganisms. Impurities may include heavy metals, residual solvents, and degradation products.
FAQ
An impurity analysis is a crucial step in the development and manufacturing process of any material or formulation. Impurities may be present at different levels and may originate from various sources, such as raw materials, reagents, solvents, water, or the production environment... These impurities can affect the quality, safety, and efficacy of the final product.
Impurity analysis makes it possible to detect and quantify impurities present in a material or formulation. The results of this analysis help determine whether impurity levels comply with 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 optimizing manufacturing processes and minimizing the risk of cross-contamination during production.
As part of an elemental 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 through the raw materials or reagents used during 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 spectrometry, ion chromatography, X-ray fluorescence, and others. The results of this analysis make it possible to determine the quantity and nature of the elements present in the material or formulation, and to verify whether they comply with regulatory and quality control specifications.
Several regulations apply to impurity analysis, depending on the industry and country. Here are a few examples:
- Pharmaceutical industries: Regulations issued by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the United States require drug manufacturers to perform impurity analysis to ensure that impurity levels in finished products comply with regulatory specifications. International Organization for Standardization (ISO) standards are also used to ensure the quality and safety of pharmaceutical products.
- Cosmetics industries: European Union (EU) and FDA regulations require cosmetics manufacturers to perform impurity analysis to ensure that finished products are free from contaminants and substances that are harmful to the skin.
- Chemical industries: EU and U.S. government regulations require chemical manufacturers to perform impurity analysis to ensure that their products do not contain substances that are hazardous to the environment or human health.
