Understanding Concomitant Components in Pharmaceutical Excipients

The article also discussed excipient composition profiles, which may include concomitant components, additives, processing aids, by-products, degradants, residual starting materials, solvents, catalysts, and reagents in addition to the nominal (labeled) component. Excipient concomitant components vs...

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Bibliographic Details
Published in:Pharmaceutical Technology 2021-02, Vol.45 (2), p.49-53
Main Authors: Putnam, Jennifer, Ullman, Katherine, Zawislak, Priscilla, Schoneker, David, Collins, George, Muse, Douglas G, Carlin, Brian, Zeleznik, Joseph, Moreton, Chris
Format: Magazinearticle
Language:English
Subjects:
Good Manufacturing Practice
Manufacturers
Manufacturing
Molecular weight
Pharmaceuticals
Polyethylene glycol
Polymers
Online Access:Get full text
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Summary:The article also discussed excipient composition profiles, which may include concomitant components, additives, processing aids, by-products, degradants, residual starting materials, solvents, catalysts, and reagents in addition to the nominal (labeled) component. Excipient concomitant components vs. impurities The International Council for Har-monisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3A, Q3B, and Q7 guidelines define impurities in drug substances and drug products; however, these definitions, as follows, do not apply to excipients: * ICH Q3A-"Any component of the new drug substance that is not the chemical entity defined as the new drug substance" (5) * ICHQ3B-"Any component of the new drug product that is not the drug substance or an excipient in the drug product" (6) * ICH Q7-"Any component of the intermediate or API that is not the desired entity" (7). Ex-cipients, however, are made using many different types of manufacturing processes, from purification of natural materials to polymer synthesis, which often yield complex mixtures of components. [...]API "impurity" concepts cannot be applied to excipients; differentiation of concomitant components from impurities is required. Polyethylene glycols (PEGs) are polymers of ethylene oxide and water labeled by the polymer's mean molecular weight.
ISSN:1543-2521
2150-7376