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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: | Stability indicating study by using different analytical techniques |
| Authors Name: | Ms.Trupti Deepak Supekar , Ms.Mahima Sharma , Ms.Prachi Kharat , Ms.Sakshi Tilekar |
| Unique Id: | IJSDR2312049 |
| Published In: | Volume 8 Issue 12, December-2023 |
| Abstract: | This write up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug products. The imperfections of described methods concerning to regulatory requirements are highlighted. A systematic approach for the development of stability-indicating methods is demonstrated in this review article. The main current goal of stability-indicating assay methods (SIAMs) is to gives information about the conditions for stress testing so as to demonstrate the stability of drug substances and drug products. This paper reviews the regulatory aspects for development of stability-indicating methods. SIAMs are used to discriminate the active pharmaceutical ingredient (API) from its potential decomposition products and substances. Regulatory guidelines in ICH Q1AR2, Q3BR2, Q6A and FDA 21 CFR Section 211 requires validated stability-indicating methods. Forced degradation is required to establish specificity when developing SIAMs and for this reason, it should be performed prior to accomplishment of stability studies. Forced degradation of the drug standard and excipients is carried out under various conditions to determine whether the analytical method is stability-indicating. The approaches for the development of stability-indicating methods are discussed. |
| Keywords: | Stability Indicating assay method, Regulatory guidelines, stress testing |
| Cite Article: | "Stability indicating study by using different analytical techniques", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 12, page no.353 - 361, December-2023, Available :http://www.ijsdr.org/papers/IJSDR2312049.pdf |
| Downloads: | 000338720 |
| Publication Details: | Published Paper ID: IJSDR2312049 Registration ID:209558 Published In: Volume 8 Issue 12, December-2023 DOI (Digital Object Identifier): Page No: 353 - 361 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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