Review on Impurity Profiling Techniques and their Importance in Pharmaceutical Field

Authors

  • T. Vinod Kumar Student of M. Pharm at School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University, Kakinada, Andhra Pradesh, India
  • V. Swetha Assistant Professor, School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University, Kakinada, Andhra Pradesh, India

Keywords:

Impurity profiling, threshold values, ICH, US-FDA, LC-MS, GC-MS.

Abstract

Impurity profiling is the process of detection, evaluation and determination of impurities present in any drug (bulk or formulated) or biological product. Impurity profiling comprises elucidation, structure, identification and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations done by LC-MS, GC-MS and CE-MS. The present review discusses many facts related to the analytical methods of development for impurity profiling of drugs. Impurity profiling is detection of problems in bulk drugs since it assists in enhancing bulk drug quality, ultimately benefiting patients. If the drugs are free from impurity then only the quality and safety of pharmaceutical products can be maintained.

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Published

2021-06-16

Issue

Vol. 8 No. 1 (2021)

Section

Review Article

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