USP is launching a new program, Impurities for Development (IfD), to assist manufacturers in their drug development efforts and help them meet quality standards and regulatory requirements to control impurities that may be harmful to patients.

Characterizing and controlling impurities in drugs under development can present significant challenges to manufacturers because they can occur for several reasons:  arising naturally within the source materials, being added as part of a product’s synthesis, occurring inadvertently during processing and manufacturing, or forming during the shelf life of the product. 

The new IfD program aims to help pharmaceutical manufacturers with custom-designed services to identify, isolate, synthesize and characterize impurities in medicines under development, allowing manufacturers to focus on other development processes. 

“An accurate and thorough understanding of impurities is essential to produce quality medicines,” says Salah Kivlighn, Ph.D., USP’s senior vice president of strategic marketing and program operations. “IfD provides real-time expertise in impurity evaluation even at the earliest stages of a product’s development cycle.” 

Prior to its launch, the IfD program was piloted for nine months with several companies, including Orchid Pharma of Chennai, India.  Orchid worked with USP to isolate and synthesize an impurity of the cephalosporin antibiotic, cefdinir. According to S. Murugan, Orchid’s head of Analytical Development (API & Formulation), “Under the IfD program, our target impurity was synthesized within the designated time line, making it possible for us to keep our cefdinir project moving forward.”