Analysis of Alkyl, Aryl Sulphonate Ester – Genotoxic Impurities (GIS) In Active Pharmaceutical Ingredient (API’s) and drug product

[摘要] This is latest series of review focused on the analysis of the genotoxic impurities (GIs),with specific reference to alkyl, aryl sulphonateester. Such reactive materials are commonly used as raw materials, reagents and intermediates in the chemical synthesis of new drugs in pharmaceutical research and development. This article reports the latest developments in the limit for controlling sulfonate esters in drug formulation doses by various regulatory environment and the latest developments in analysis culminating in a review of analytical approaches in literature. The literature is sub-categorized by technique of separation (gas chromatography (GC), high-performance liquid chromatography (HPLC) and further tabulated by type of Active Pharmaceutical Ingredient (API) and impurity with brief information and references of the process. Such a wide range of options allow the analyst to choose the most suitable technique specific to their needs.

[学科分类] 药学

[关键词] Alkyl and Aryl Sulphonate Ester;Genotoxic Impurity;Chromatographic;Spectroscopic;Derivatization