Stability testing on a drug or active ingredient (API) in a laboratory

Your needs : to conduct stability testing on a drug or active ingredient (API) as part of quality control or of an R&D project

Studying the stability on a drug or active ingredient (API) is a crucial step during its development or approval.

The performance of a drug or active ingredient (API) depends on many parameters which can change over time. This is why the aim of stability testing is to understand how a drug or active ingredient (API) changes in various preestablished conditions over a certain amount of time to study how its compliance (performance, chemical composition…) changes in these conditions.

Support from a laboratory such as FILAB will allow you to ensure the compliance and the stability of your pharmaceutical drugs and active ingredients.

Our solution : to assist you in conducting stability testing as part of quality control tests or of an R&D project

FILAB laboratory offers stability testing services for your pharmaceutical drugs or active ingredients (APIs). Thanks to an analytical fleet spread over 2100m² and a team made up of highly qualified individuals, FILAB is able to provide the following services :

  • Stability testing following the ICH Q1A guideline
  • Analytical development and validation to study a product’s stability
  • Forced degradation testing on active ingredients following the ICH Q1A guideline
  • Analysis of the final chemical composition of a product depending on environmental factors (temperature, humidity, light exposure…) by GC-MS, HPLC, or FTIR
  • Study of container/contents interactions
  • Analysis and identification of impurities (molecular characterizations…)
  • Analysis of active ingredients
  • Analysis and determination of degradation products

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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