The US FDA registers ingredients in medicinal products and assigns Unique INgredient Identifiers (UNIIs) that must be used by companies marketing their products in the US. Many inactive ingredients (excipients) receiving UNIIs are polydisperse materials such as polymers. Despite the registration of polymers complying with the ISO 11238 standard, multiple alternative representations are possible because of the generality of the standard on the one hand and the lack of chemoinformatical standards for description of polydisperse materials on the other. Here we describe an approach for standardization of the structural representation of polymers for data identification and exchange purposes. The approach is based on the InChI algorithm and is used to populate substance indexing files that accompany product labels published by FDA on the DailyMed website.<br/>

Standardization of structural representation of polymers used in medicinal products

2019 Fall National Meeting

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