STABILITY INDICATING CHROMATOGRAPHIC METHODS FOR ACTIVE PHARMACEUTICAL INGREDIENTS AND FORMULATIONS - A REVIEW
Vijayaraj Surendran, Rathinasamy Gandhimathi, T. Harika, B. Chandrasekhar, G. Pallavi
Abstract
Vijayaraj Surendran, Rathinasamy Gandhimathi, T. Harika, B. Chandrasekhar, G. Pallavi
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.
OpenAlex reports 1 citations for this work. Citation counts describe recorded attention and do not establish research quality.
A contribution statement is not available in the OpenAlex record.
Method details are not available in the OpenAlex metadata.
Findings are not separately available in the OpenAlex metadata.
Limitations are not available in the OpenAlex metadata.
Application details are not available in the OpenAlex metadata.
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