Abstract
Determination of Impurities in Pharmaceuticals: Why and How?
Highlights
As defined by the United States Pharmacopeial (USP), impurity is “any component of a drug substance that is not the chemical entity defined as the drug substance and in addition, for a drug product, any component that is not a formulation ingredient” [1].Impurities in drug substance or drug product can arise due to synthetic/manufacturing processes, degradation, storage conditions, container, excipients, or contamination
Quality Management and Quality Control - New Trends and Developments prior to take subsequent steps; for instance, to distinguish an impurity which is derived from API alone or derived from interaction products of APIexcipient, excipient-excipient, or API-residual impurities existing in excipients [4–6]
As said by the requirements of International Council for Harmonization (ICH) Q3A(R2), all types of impurities present in API at a level greater than (>) the identification threshold must conduct studies to characterize their structures, no matter they are shown in any batch manufactured by the proposed commercial process or any degradation product observed in stability studies under recommended storage conditions
Summary
As defined by the United States Pharmacopeial (USP), impurity is “any component of a drug substance that is not the chemical entity defined as the drug substance and in addition, for a drug product, any component that is not a formulation ingredient” [1]. Impurities in drug substance (i.e., active pharmaceutical ingredient, API) or drug product can arise due to synthetic/manufacturing processes, degradation, storage conditions, container, excipients, or contamination. They can be identified or unidentified, volatile or nonvolatile, organic or inorganic species [1–3]. Despite an increase in the research of impurities, a number of problems are still arisen in the development of identification technologies for degradation products and pathways. The first type of API-related impurities is generated by degradation of API itself under specific storage conditions, e.g., oxidation, dehydration, carbon dioxide removal, etc. The other type is occurred due to the interaction between API and excipients, container, or residual impurities in excipients, reagents, or solvents [8, 9]. Studies of impurities are one of the most important works in the development of APIs and drug products [1, 16, 17]
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