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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
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| Paper Title: | Degradation and Stability Profiling in Pharmaceutical Analysis: Review |
| Authors Name: | Kanchan Dhanappa Nagrale , Pooja Lenin Kumbhar , Manoj.S.Charde , Ritu .D.Chakole |
| Unique Id: | IJSDR2209067 |
| Published In: | Volume 7 Issue 9, September-2022 |
| Abstract: | Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation studies. Thus, this review discusses about the current trends in performance of forced degradation studies by providing strategy for the conduct of studies, degradation mechanisms and also describes the regulatory aspects of force degradation and the study of stability and also the analytical methods helpful for development of stability indicating method. |
| Keywords: | Forced degradation, Stability indicating methods, ICH guidelines |
| Cite Article: | "Degradation and Stability Profiling in Pharmaceutical Analysis: Review", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.7, Issue 9, page no.403 - 408, September-2022, Available :http://www.ijsdr.org/papers/IJSDR2209067.pdf |
| Downloads: | 000336852 |
| Publication Details: | Published Paper ID: IJSDR2209067 Registration ID:201651 Published In: Volume 7 Issue 9, September-2022 DOI (Digital Object Identifier): Page No: 403 - 408 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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