CD Formulation Offers Forced Degradation Studies

To ensure the safety and efficacy of the drug product, chemical stability is of paramount importance. Earlier this month, CD Formulation announced its decision to launch forced degradation studies to help researchers find ways to promote drug stability.

The forced degradation study, also known as stress testing, is carried out to produce representative samples for developing stability-indicating methods for drug substances.

As a vital analytical aspect, forced degradation study generates degradation products for further research so that the stability of drug molecules can be determined. “More knowledge of molecule stability has two major benefits: one is to help select proper formulation and package; the other is to provide proper storage conditions and shelf life. Both are essential for regulatory documentation. Our forced degradation studies, together with our end-to-end enhancement solutions, will help drive drug development projects more swiftly to the commercialization stage, while at the same time lowering project complexity, timelines, and risk,” says Marketing Chief of CD Formulation.

The forced degradation services provided by CD Formulation include:

Oxidative degradation studies

Degradation mechanism analysis

Provision of related data services

Generally, the degradation of active pharmaceutical ingredients should be examined in both solid and solution states. It is highly encouraged to start this forced degradation testing and analysis early in the preclinical phase or phase I of clinical trials. This will help gain sufficient time for identifying degradation products and structure elucidation. An early start not only makes it possible to optimize stress conditions, but also gives timely recommendations for making improvements in the manufacturing process as well as proper selection of stability-indicating analytical procedures.

However, it should be noted that as no specific set of conditions applies to all drug products or drug substances, regulatory guidance does not specify the conditions to be used. In such a case, CD Formulation is advantageous for its long-standing expertise in conducting forced degradation as well as other drug stability services.

Please visit https://www.formulationbio.com/forced-degradation-studies.html to learn more about CD Formulation’s capabilities in forced degradation studies as well as other pharmaceutical preparation services.