Module 3 Presentations

07/05/2024

S.1.1 Nomenclature  International Nonproprietary Name  Issued by WHO: Recommended, Proposed  Compendial Name  European Pharmacopeia  Chemical Name (systematic name)  International Union for Pure and Applied Chemistry (IUPAC)  Chemical Abstracts Service (CAS)  Other Name(s)  Acronym, Trivial name  Laboratory Code  British Approved Name ->Issued by the British Pharmacopoeia Commission  United States Adopted Name -> Issued by the US Adopted Names Council  Japanese Accepted Name

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

31

Guiding Principles

 Distinctive in sound and spelling  Show group relationship to pharmacologically related  substances (stems)  Not too long  Not confusing with common words  No conflict with trade marks  Not misleading  Not suggestive to patient

 In addition: 

Possibility of new stem for new group One-word name for acids; salts use name of acid or base e.g. “oxacillin”and “oxacillin sodium”





Avoid isolated letters or numbers Harmonised spelling



Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

32