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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