Ensure the quality, safety, and compliance of your products
An organic impurity is any organic component other than the chemical entity being analyzed. Organic impurities can be either resi
Organic impurities are any organic substances present in a material or formulation other than the main intended compound. They may originate from synthesis residues, degradation products, solvents, intermediates, contaminants, or interactions within the product lifecycle.
Accurate identification and quantification of organic impurities play a crucial role in:
- Ensuring purity, stability, and safety of raw materials and finished products
- Meeting regulatory requirements (pharmaceutical, cosmetic, chemical industries, etc.)
- Preventing product degradation, toxicity issues, and non-compliance risks
- Supporting R&D, formulation development, and routine quality control
FILAB provides advanced analytical capabilities to help you control, monitor, and understand impurities in even the most complex matrices.
FILAB laboratory provides its customers with its expertise and analytical tools for the analysis of organic impurities
With an analytical park of 5200m², the FILAB laboratory assists industrialists in the research and identification of impurities in their materials and formulations.
In order to respond to these problems with precision and reliability, FILAB offers a wide range of analytical techniques, adapted to any type of material:
Qualitative analysis by GC-MS chromatography
Impurity profiling (related substances) by HPLC-UV/MS
Analysis of an organic impurity by LCQTOF, LC-UV, NMR
Quantitative analysis of the 30 most common elements by ICP-AES
Analytical development in the laboratory by GC-MS or LC-MS
Search for impurities in a pharmaceutical product (ICH guideline or according to the EP)
FAQ
Organic impurities are unwanted organic substances present in a product or material.
They can include solvents, intermediates, degradation products, synthesis by-products, or contaminants introduced during manufacturing.
It ensures product safety, purity, and regulatory compliance, prevents degradation or toxicity issues, and supports development and quality control activities.
We use GC-MS, HPLC-UV/MS, LC-QTOF, NMR, ICP-AES, and other advanced techniques depending on your matrix and objectives.
Yes. FILAB can perform analyses in compliance with ISO 17025, ICH Q3, Pharmacopoeia guidelines, and other industry regulations.
Absolutely. we work with pharmaceuticals, chemicals, polymers, cosmetics, medical devices, packaging, and many more material categories.
Yes, our experts can develop or validate tailor-made methods suited to your materials and regulatory requirements.
Please include the sample type (API, raw material, finished product, etc.), the number of samples, the analytical method required (pharmacopoeial, in-house, or method development), and any known target impurities or regulatory expectations.
Once we receive all necessary details, our team typically provides a customized quote within 24–48 hours.
