Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances
By: PARMAR, I
.
Contributor(s): RATHOD, H.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2021Edition: Vol.83(3), May-June.Description: 402-415p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: 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
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
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Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2021-2022548 |
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
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