Understanding the degradation pathway of an API is essential during preformulation study, as it directly influences excipient selection and stability study planning. Forced degradation studies provide insights into how an API degrades under stress (e.g., heat, light, pH, oxidation), helping predict chemical stability and ensuring compatibility with excipients. Key Benefits of Forced Degradation Studies: Degradation…
Forced degradation is not that simple as it seems where you just degrade with Acid, base, oxidation, light, light and present the data in a table form. It is elaborate study where we evaluate each or every impurity and discuss the potential risk. It is also a risk assessment tool. It goes beyond stressing the…
Oxidation Degradation Oxidation is the second most common degradation pathway for pharmaceuticals, after hydrolysis. Oxidation degradation studies are conducted in the pharmaceutical industry to determine the stability of drugs under conditions that may induce oxidation, such as exposure to light, heat, or oxygen. The goal of these studies is to identify the degradation products…
Photolytic Degradation Photolytic degradation is a type of forced degradation that occurs when a drug molecule is exposed to light. The photolytic degradation process typically involves three steps: 1. Light Absorption: The first step in photolytic degradation is the absorption of light by the target molecule. Different molecules have varying abilities to absorb light…
