Investigating The Root Cause Of Discoloration On Stability Samples Of Tablets

To investigate the root cause and potential mechanism behind the areas of discoloration on stability samples of pharmaceutical tablets.

A common problem observed on drug product appearance is the occurrence of black specks or areas of discoloration on pharmaceutical tablets. Example is shown in Figure 1. There are many potential causes for this issue. For example, the source and manufacturing of raw materials, the tablet manufacturing process, and the storage process/conditions. Tablet discoloration during storage is usually complicated to investigate since it can involve interaction between active, excipients and packaging materials.

In the present study, we describe the investigation of dark areas on stability samples of tablets observed after 3 months storage at 40°C/75%RH. Microbial testing, excipient compatibility studies and chemical analysis were conducted to investigate the root cause behind the dark specks.