A monograph in pharmacy is a written document that reflects the quality attributes of medicines approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the World Health Organization (WHO). It includes information on the identity, strength, purity, and performance of a medicine, as well as the tests to validate that a medicine and its ingredients meet these criteria
. Monographs are used to ensure the quality of medicines and their ingredients, and to protect the safety of patients
. They contain detailed parameters used to determine whether a medicine meets key quality attributes
. Monographs are essential for setting quality standards for medicines and are utilized in many countries worldwide
