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Abstract

IMPURITY PROFILE IN PHARMACEUTICS

Nikita Roham, Gundgole Shwetarani and Gorde Prasad*

Abstract

Impurity has no clear meaning in the pharmaceutical industry. Impurity profiling involves the recognition, structural characterization, and identification and quantification of impurities and decomposition products in bulk medical properties and pharmaceutical preparations. Different forms of contaminants can be detected, identified, and quantified using impurity profiling. Organic, inorganic, and residual solvents are the three types of contaminants that are classified. Intermediates, starting materials, degradation products, reagents, ligands, catalysts, and by products are all examples of organic impurities. Heavy metals, residual solvent, inorganic salt, filter, aids, charcoal, and reagents are examples of inorganic impurities. Various analytical procedures such as UV, HPLC, LC-MS, GC-MS, SCFC, and others can be used to profile pharmaceutical impurities. Starting materials, intermediates, penultimate impurity, by product, and degradation product are all examples of impurities.

Keywords: Impurity, Classification, Identification method, Source, Application.


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