Analysis of related substances of pharmaceutical products

Your needs: analyze the related substances present in your pharmaceutical products

To begin with, related substances are organic impurities. They can be derived from intermediates also called by-products of synthesis or degradation products. Once identified, these substances have an acceptance threshold when they are present in a pharmaceutical product.

Indeed, related substances are the subject of monographs in the pharmacopoeia. Regulations have been defined that describe the requirements they must meet to guarantee the quality of the medicine.

Are you looking for a reliable and responsive analytical laboratory with know-how and analytical expertise? Call on FILAB!

Our solutions: supporting pharmaceutical manufacturers in the research and quantification of related substances in pharmaceutical products

FILAB offers pharmaceutical companies technical expertise and state-of-the-art analytical equipment. Indeed, FILAB offers you tailor-made expertise services for the research and quantification of related substances in your drug or active ingredient (API):

Our services

  • Analytical development in laboratory by GC-MS or LC-MS

  • Analysis of the final chemical composition of the product according to the environmental conditions (temperature, humidity, exposure to light...) by GC-MS, HPLC or FTIR

  • Study of container-content interactions

  • Analysis of active ingredients

  • Analytical laboratory validation according to the ICH Q2 guideline

  • Stability study according to ICH Q1A

  • Analysis and identification of impurities (molecular characterizations,...)

  • Laboratory support and advice

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

Thank you !

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