Journal: Journal of Pharmacy Research

Article Id: JPRS-QA-00001388
Title: Impurity profile of pharmaceuticals ingredient: a review
Category: Quality Assurance
Section: Review Article
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  • Abstract

    Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency areemphasizing on the purity requirements and the identification of impurities in ActivePharmaceutical Ingredient’s (API’s). Qualification of the impurities is the process of acquiringand evaluating data that establishes biological safety of an individual impurity; thus, revealingthe need and scope of impurity profiling of drugs in pharmaceutical research. Impurities in pharmaceuticals are the surplus chemicals that stay behind with the active pharmaceutical ingredients or develop during formulation or upon aging of both active content and formulated active ingredients to medicines. The efficacy and safety of pharmaceutical product is affected by presence of unwanted traces of impurities. Impurity profiling is deals with detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities as well as residual solvents in bulk drugs and pharmaceutical formulations. Impurities in pharmaceuticals are the surplus chemicals that stay behind with the active pharmaceutical ingredients or develop during formulation or upon aging of both active content and formulated active ingredients to medicines. The efficacy and safety of pharmaceutical product is affected by presence of unwanted traces of impurities. The advent of hyphenated techniques has revolutionized impurity profiling, by not only separation but structural identification of impurities as well. The present review covers various aspects related to the analytical method development for impurity profiling of an active pharmaceutical ingredient.

    Cite this article as: Warad T.A., Bhusnure O.G, Gholve S.B.,Impurity profile of pharmaceuticals ingredient: a review,Journal of Pharmacy Research 2016,10(7),523-533.

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  • About the authors and Affiliations

    Author(s) Name:

    Warad T.A., Bhusnure O.G*, Gholve S.B.

    Affiliation(s) Name:

    Channabasweshwar Pharmacy College ( Degree ), Dept of Quality Assurance, Latur (MS), India

    *Corresponding author.
    Dr. Bhusnure O.G., M. Pharm, Ph.D.
    Professor and Head
    Department Of Quality Assurance,
    Channabasweshwar Pharmacy College,
    Kava Road, Latur-413512, Dist. Latur. (MS),India.

    Received on:12-05-2016; Revised on: 22-06-2016; Accepted on: 27-07-2016

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    Author:

    Warad T.A., Bhusnure O.G*, Gholve S.B.

    Title:Impurity profile of pharmaceuticals ingredient: a review
    Journal:Journal of Pharmacy Research
    Vol(issue):10 (August)
    Year:2016
    Page No: (523-533)
  • Experimental Methods Keywords

    Methodology: Characterization,Guideline
    Research Materials:Pharmaceuticals ingredient

Keywords

Degradation Product Impurity ICH Guideline Characterization Tech.

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