New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis

Over-the-counter (OTC) medication is used by almost every individual from teething infants to our oldest citizens. The high utilization rate of these medications makes managing the quality of OTC products a crucial part of the pharmaceutical manufacturing process.

The US FDA’s Over-the-Counter Drug Monograph System facilitates the marketing of OTC products, provided that they comply with the corresponding USP monograph, if one is available. However, there are thousands of OTC products for which USP does not have a monograph, and the monographs that USP does have are sometimes not up-to-date. To address this issue, the United States Pharmacopeia has launched a global initiative to modernize monographs that have traditionally featured wet chemistry methods with selective and sensitive methodologies that reflect recent innovations and technology updates.

In this webinar Dr. Edith Chang, Team Leader of Chemical Medicines at USP, will discuss the challenges, strategies, and prioritization with OTC monograph modernization. Dr. Michael Chang, Scientific Liaison of Chemical Medicines at USP, will share successful monograph modernization updates and the USP’s progress. Finally, Dr. Hari Narayanan from Metrohm USA will provide a high-level overview of using ion chromatography (IC) for identification, assay, and impurities of drug products.