Forced Degradation Studies

CD Formulation offers forced degradation studies that help customers find ways to promote drug stability. Our end-to-end enhancement solutions combine complete capabilities from concept to commercialization, minimizing project complexity, timelines, and risk.

The Main Objectives of Conducting Forced Degradation Tests Include:

• Resolve the degradation products and determine the degradation pathway and mechanism of the drug.
• Help the development of API processes, formulation prescriptions and processes, and to help the screening of drug salts and crystalline forms.
• Provide support for drug safety.
• Guide the development of drug packaging systems and to determine storage conditions.

Our Services

CD Formulation provides forced degradation services to help make drug manufacturing safer and more effective. The services provided are:

Oxidative degradation studies.
Degradation mechanism analysis.
Provision of related data services.

Basic Requirements for Forced Degradation

The degradation of APIs will generally be examined in both solid and solution states. The solid state of the API is generally examined in the light, heat and humidity and heat conditions of degradation, selective oxidative degradation; the solution or suspension state of the API is generally subjected to high temperature, hydrolydation, oxidation and light tests. API forced degradation test should be set up non-degradation group as a control group.

Requirements for Mandatory Degradation Tests at Different Stages of Drug Development

The progress of pharmacological development is closely related to the clinical process of drugs, and as drug development progresses, the understanding of the structural analysis of drug degradation products and degradation pathways also need to be continuously advanced.

It is generally believed that the mandatory degradation study can be started before the clinic, and at this time, the analysis of the degradation products can not be carried out, and the mandatory degradation test study is mainly for the development of analytical methods for the substances concerned.

Why Choose CD Formulation?

• Comprehensive integration of pharmaceutical R&D supporting products.
• Long-standing expertise in field solid state characterization to support the development of custom and proprietary active pharmaceutical ingredients.
• Comprehensive advanced equipment, can achieve high capacity, fast turnover, support development, stability, batch release.

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

1. Singh S., Junwal M., Modhe G., et al. Forced degradation studies to assess the stability of drugs and products[J]. TrAC Trends in Analytical Chemistry, 2013, 49(3):71-88.
2. Hasija M., Li L., Rahman N., et al. Forced degradation studies: an essential tool for the formulation development of vaccines[J]. Vaccine Development & Therapy, 2013, 2013(default):11-33.
3. Brummer H . How to approach a forced degradation study. 2011.