ISSN : 2663-2187

Study of Selected Non-Deliberately Supplementary Substances in Pharmaceutical Formulations by Using Hptlc

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Stuti Pandya, Nasir Vadia, Navin Sheth
» doi: 10.33472/AFJBS.6.6.2024.8975-8983

Abstract

The safety and efficacy of pharmaceutical products along with packaging material needs to be addressed. To maintain purity of product the whole process starting from raw material to end users should be selective, as the chances of impurity entered the product at any stage of the process. These types of impurities are known as extractables and leachables among them extractables are extracting components from the packaging material while in case of leachables are migrating components from the extracting ones. According to regulatory authorities the extractables and leachables impurities data are maintained by parenteral drug associations, USFDA. In current scenario the ICH guideline has introduced guidelines on extractables and leachables under Q3E (Expert Working Group). In present work various analytes were tried to develop a selective and sensitive method by high performance thin layer chromatography, but after performing certain trials the expected results were not generated. To get a nearest idea about the analyte finest methods like LC-MS/MS for non-volatile organic compounds, GC-MS/MS for volatile organic compounds and ICP-OES for metal compounds may help appropriately.

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