2012•Unpublished venueRequires access

STABILITY INDICATING CHROMATOGRAPHIC METHODS FOR ACTIVE PHARMACEUTICAL INGREDIENTS AND FORMULATIONS - A REVIEW

Vijayaraj Surendran, Rathinasamy Gandhimathi, T. Harika, B. Chandrasekhar, G. Pallavi

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Abstract

The article highlights on the development of validated stability indicating methods for active pharmaceutical ingredients and formulations. International Council on Harmonization (ICH) prescribed different stress test conditions and degradation studies for testing the stability of active pharmaceutical ingredients and formulations is emphasized. A systematic approach for the development of stability indicating chromatographic methods is also discussed.

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What this paper is about

The article highlights on the development of validated stability indicating methods for active pharmaceutical ingredients and formulations. International Council on Harmonization (ICH) prescribed different stress test conditions and degradation studies for testing the stability of active pharmaceutical ingredients and formulations is emphasized. A systematic approach for the development of stability indicating chromatographic methods is also discussed.

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Available abstract

The article highlights on the development of validated stability indicating methods for active pharmaceutical ingredients and formulations. International Council on Harmonization (ICH) prescribed different stress test conditions and degradation studies for testing the stability of active pharmaceutical ingredients and formulations is emphasized. A systematic approach for the development of stability indicating chromatographic methods is also discussed.

Key concepts: Active ingredient, Chromatography, Pharmaceutical formulation, Forced degradation, Biochemical engineering, Chemistry, Medicine, Pharmacology

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