Physical Appearance Determination Of A Drug Substance Utilizing A Commercially Available Color Guide

By Jennifer Alligood, Kimberly Lupo, Joe Cobb, Lauren McNeil, Ashley Dunning, Lauren Brock, Ken Jones, Credle Harris, Marjorie Misiura, David Nelson, and Kym Risp

To develop a robust method to determine the physical color appearance of drug substance X that eliminates the subjective human bias for color selection.

Physical appearance testing can be the most subjective but important tests performed on drug substances. The polymorphous form can provide information regarding the solid state of the material. The color can be an indication of purity and a means to identify contamination that occurred during the synthesis process. Typical testing involves viewing the material against a white background under specified lighting and reporting the color and form. Due to human bias observed during physical appearance testing of drug substance X, a commercially available color guide was utilized to develop a robust method to determine the physical appearance of said material.