PROJECTS

Stability and Degradation Studies

Client: The client company is one of the leading chemical-pharmaceutical companies in the world,
engaged for decades in the development of new medicines and in the introduction of cutting-edge
technologies and innovative ways of managing health.

Sector: chemical-pharmaceutical

Objective: to carry out stress testing and stability studies on certain formulations (in order to obtain available data on the onset of impurities and on the setting of specification limits).

Our contribution

The client chose to cooperate with the S4BT Laboratory consultants, who focused on:

exposure of the samples to the various degrading agents obtained
drafting of related protocols
execution of tests on a periodic basis related to degradation
preparation of the final report with evaluation of the results

Result

The project allowed the client to further strengthen a production approach oriented towards quality and continuous improvement, in compliance with ICH guidelines and internal policies.

The study has proved effective and invaluable and has been used in the client’s facilities all over the world.

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Projects completed in 2019

CLIENT

Pharmaceutical Company

An international pharmaceutical organisation specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

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