Greenville, NC (PressExposure) March 21, 2011 -- GREENVILLE, N.C. - If you're a scientist working with an active pharmaceutical ingredient (API) that has the potential to cure or kill, its color would seem like the least of your concerns.
As it turns out, color is important - because color can alert a scientist to possible degradation or the presence of impurities.
Yet - as anyone who has taken home paint samples with names like cloud, sand and eggshell knows - the interpretation of color is subjective. One person's peach is another person's apricot.
So scientists at Metrics Inc. set out to develop a quantifiable method by which one could eliminate subjective human bias in the determination of API color.
That team headed by Jennifer Alligood, senior group leader, and Kimberly Lupo, laboratory supervisor, recently presented its findings at the annual meeting of the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy. Pittcon attracts 20,000 attendees from industry, academia and government representing 90 countries and donates $1 million-plus each year to educational causes including museums and libraries. For their study, Metrics scientists presented known quantities of API to participants and asked them to identify the color of samples using visual appearance alone while following standard pharmaceutical industry practice - viewing API against a white background under laboratory lighting.
Fewer than half of the participants identified the API consistently by visual examination alone. Then the Metrics team developed an alternate method using the Pantone® Formula Guide. Essential to artists and graphic designers, the Pantone guide with its 1,114 subtly differing shades is considered to be the world's authority on color authenticity. Using that guide, the team assigned specific ranges of color shades to known quantities of API samples.
Again, the team presented samples to participants - only this time, participants examined them using a light booth under diffused daylight and compared them to corresponding Pantone color shades.
Nearly 90 percent of participants correctly identified API based on color alone - a significant improvement.
"Our research found that it is possible to eliminate the color bias of the human eye," Alligood said. "Even participants who had never encountered a particular API previously could consistently identify the color when using a standardized method of color determination. The outcome was impressive."
Alligood said she hoped her team's research could lead to a new and more objective standard of color determination for the pharmaceutical industry.
Metrics Inc. is one of the most respected contract pharmaceutical development and manufacturing companies in the United States today. Started as an analytical laboratory in 1994, Metrics has evolved into a full-service provider of quality pharmaceutical formulation development; first-time-in-man (FTIM) formulations; clinical material manufacturing (CTM) for Phase I, II and III trials; commercial manufacturing; and analytical method development and validation services.