Recent and Advance study on Impurity Profiling A Review
Author(s):
Mayuri Annaso Patil, Priti Babasaheb Patil , Rutuja Rajendra Mali , Anuradha mahesh savairam
Keywords:
Ingredient, Impurity, product development, pharmacopoeias, regulatory bodies.
Abstract
The main aim of pharmaceutical product development is to cure and prevention of disease with achieve safety and efficacy. In every Active Pharmaceutical Ingredient, Impurity is present. In pharmaceutical industry, Purity profile is important factor as well as Impurity profile is important and mandatory according to Regulatory authority. In the pharmaceutical world, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances present in drug and also arise out of synthesis or unwanted chemicals that remains with APIs. The quality of drug product is highly affected by impurity present in drug. There are different types of impurities such as organic impurity, Inorganic impurity, residual solvent starting materials, intermediates, by product and degradation product etc. The International Conference on Harmonisation (ICH) guidelines, state the definitions of the impurities in new drug substances. In this article, we have discussed the types of possible impurities and their sources. We have also listed out the impurity isolation techniques and analytical techniques for the identification, quantification and characterization of impurities.
Article Details
Unique Paper ID: 162008

Publication Volume & Issue: Volume 10, Issue 7

Page(s): 207 - 216
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