A monograph is a written document, or standard, that describes an item (e.g., a finished drug, a drug ingredient, impurity or excipient). Many of the existing pharmaceutical and biopharmaceutical assays (e.g., those from the United States Pharmacopeial Convention [USP], and other pharmacopeias) are time consuming, labor-intensive, involve hazardous chemicals, require extensive analyst training, and may yield significant measurement errors. In recognition of this the USP embarked on a monograph modernization initiative, aligned with the methods in other pharmacopeias and the International Conference on Harmonization (e.g., ICH Q3A and Q3B), and current FDA guidance. Ion chromatography (IC) plays a key role in drug monograph modernization because it offers a significant improvement to existing active pharmaceutical ingredient, impurity and counterion assays, with advantages in speed, reproducibility, accuracy, safety and cost-effectiveness. This learning portal, produced in collaboration with Thermo Fisher Scientific, provides learning content, advice and guidance for the transition to modernized pharmacopoeial methods using IC.
