A Review on Impurity Profiling and its Regulatory Aspects- An Important and Necessary Tool in Stability Studies

Abstract

The chemistry of plants is as divergent as the great variety of forms in which plants occur. The therapeutically important constituents are usually found to be associated with many inert substances. The active principles are extracted from plant drugs and purified for therapeutic utility for their selective and regulated activity. The quality control of the herbal crude drugs and their bio constituents is of paramount importance in justifying their acceptability for present pharmaceutical industry standards. One of the major problems faced by the user industry is the non-availability of rigid quality control profiles for herbal raw materials and their formulations. It is, discovered that the crude drugs in commerce are often adulterated and don't go with the standards prescribed for authentic drugs. The cornerstones of bringing new medicines to market are quality, safety, and efficacy. These attributes are controlled using a variety of analytical procedures aimed at characterizing drug substance and drug product purity. A key step of delivering on these aspects is a detailed understanding of the impurity profile of a drug substance and the final product. Unani drugs have to go through stability testing as it has been made mandatory through regulatory authorities from 2019. Though it was notified in 2017 two years were provided to tune with the guidelines. The present paper summarizes the concept of impurity profiling from its basics to its regulatory aspects in detail as a preliminary guide and is part of the larger study related to stability studies of single drugs of Unani medicine. Hence there is a need for impurity profiling of the crude drugs. The other part of the study that details about the protocol for stability testing for the Unani drugs will be communicated in the near future. © 2020 iGlobal Research and Publishing Foundation. All rights reserved.