Ranitidine (DB00863): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Regulatory Withdrawal due to N-Nitrosodimethylamine (NDMA) Contamination

Section 1: Chemical Profile and Physicochemical Properties

[Ranitidine is a small molecule drug that, for decades, was a cornerstone in the management of acid-related gastrointestinal disorders. Its journey from a celebrated therapeutic agent to a product withdrawn from global markets is rooted in its fundamental chemical nature. A thorough understanding of its chemical identity, structure, and physicochemical properties is therefore essential, as these characteristics not only defined its therapeutic efficacy but also contained the latent potential for its ultimate failure. This section provides a definitive chemical and physical fingerprint of ranitidine, establishing the foundation for the subsequent analysis of its pharmacology, clinical use, and regulatory history.]

1.1 Nomenclature and Identifiers

[To unambiguously identify the compound across scientific literature, regulatory documents, and clinical practice, a comprehensive list of its names and identifiers is crucial. Ranitidine was marketed globally under a multitude of brand names and is cataloged in numerous chemical and pharmacological databases.]

[The most widely recognized brand name for ranitidine was Zantac.][1][ Other brand names used in the United States and internationally included Acid Reducer, Taladine, Berkley and Jensen Acid Reducer Maximum Strength, and Deprizine.][4][ Synonyms encountered in various markets include Ratic, Raticina, RND, Sampep, Taural, Zantic, Azantac, Raniplex, and Ranidil.][5][ The international nonproprietary name (INN) system also provides standardized names in different languages, such as]

Ranitidin[ (German), ]Ranitidina[ (Spanish), and ]Ranitidinum[ (Latin).][1]