Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances (Record no. 15728)

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005 - DATE AND TIME OF LATEST TRANSACTION
control field 20211224093247.0
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040 ## - CATALOGING SOURCE
Original cataloging agency AIKTC-KRRC
Transcribing agency AIKTC-KRRC
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9 (RLIN) 15035
Author PARMAR, I.
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Title Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances
250 ## - EDITION STATEMENT
Volume, Issue number Vol.83(3), May-June
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. Mumbai
Name of publisher, distributor, etc. Indian Journal of Pharmaceutical Science
Year 2021
300 ## - PHYSICAL DESCRIPTION
Pagination 402-415p.
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Summary, etc. Impurity is an unwanted substance present in the active pharmaceutical ingredients that form during
the synthesis process of active pharmaceutical ingredients or any unwanted constituent that is produced
besides the active ingredient during the formulation or the aging of active pharmaceutical ingredients.
Even the insignificant quantity of impurity existing in the medicinal product may harm the patient life and
compromises the purity and superiority of the medicinal product. According to International council for
harmonisation guidelines, analytical monitoring of impurity is a prerequisite and mandatory requirement
for approval of market authorization of the new drug substance. Any pharmaceutical product would be
capable to serve their intended therapeutic activity when they are free from impurity. Thus, an impurity
existing in an active pharmaceutical ingredient needs to be identified and quantify with the help of modern
analytical approaches. This review explores the basic information concerning impurity profiling, highlights
the advantages of an analytical technique and also focuses on the limitation of different analytical methods
for impurity profiling with possible ways to overcome the limitation
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
9 (RLIN) 4639
Topical term or geographic name entry element PHARMACEUTICS
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9 (RLIN) 15036
Co-Author RATHOD, H.
773 0# - HOST ITEM ENTRY
Title Indian journal of pharmaceutical sciences
Place, publisher, and date of publication New Delhi
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URL https://www.ijpsonline.com/articles/a-review-recent-trends-in-analytical-techniques-for-characterization-and-structure-elucidation-of-impurities-in-the-drug.pdf
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Koha item type Articles Abstract Database
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          School of Pharmacy School of Pharmacy Archieval Section 2021-12-24 2021-2022548 2021-12-24 2021-12-24 Articles Abstract Database
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