A Systematic Review of Impurity Profiling and Stability Studies in Pharmaceutical Drug Substances

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nThis is an unedited manuscript accepted for publication and provided as an Article in Press for early access at the author’s request. The article will undergo copyediting, typesetting, and galley proof review before final publication. Please be aware that errors may be identified during production that could affect the content. All legal disclaimers of the journal apply.n

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Year : 2025 [if 2224 equals=””]04/10/2025 at 12:19 PM[/if 2224] | [if 1553 equals=””] Volume : 16 [else] Volume : 16[/if 1553] | [if 424 equals=”Regular Issue”]Issue : [/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] 03 | Page :

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    Anand Prakash,

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  1. Student, Department of Pharmaceutical Chemistry, S.N. College of Pharmacy, Jaunpur, Uttar Pradesh, India

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nEnsuring the safety, efficacy, and quality of pharmaceutical goods is essential in the Indian pharmaceutical market, which is a global centre for generic drugs. Stability studies and impurity profiling are two fundamental activities that ensure this quality during the whole lifespan of a medicine. The effect of environmental variables such as temperature, humidity, and light on the quality of a drug substance over time is demonstrated by stability studies. The identification, quantification, and characterization of impurities that may arise during storage or production are all part of impurity profiling, a crucial element of stability studies. The scientific underpinnings, regulatory standards (mainly ICH Q1A-R2, Q3A-R2, and Q1B), and contemporary analytical methods (like HPLC, LC-MS, GC-MS) utilized in these critical procedures are all covered in this thorough systematic review. The article aims to bring together Indian pharmaceutical researchers, scientists, and students in order to highlight the strategic significance and real-world difficulties of this research. in making sure that every tablet, capsule, or injection that the Indian patient receives is both safe and effective.nn

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Keywords: Stability studies, impurity profiling, ICH guidelines, forced degradation, HPLC, LC-MS, drug degradation, shelf life, and pharmaceutical analysis

n[if 424 equals=”Regular Issue”][This article belongs to Research and Reviews: A Journal of Pharmaceutical Science ]

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[/if 424][if 424 equals=”Special Issue”][This article belongs to Special Issue under section in Research and Reviews: A Journal of Pharmaceutical Science (rrjops)][/if 424][if 424 equals=”Conference”]This article belongs to Conference [/if 424]

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How to cite this article:
nAnand Prakash. [if 2584 equals=”][226 wpautop=0 striphtml=1][else]A Systematic Review of Impurity Profiling and Stability Studies in Pharmaceutical Drug Substances[/if 2584]. Research and Reviews: A Journal of Pharmaceutical Science. 04/10/2025; 16(03):-.

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nAnand Prakash. [if 2584 equals=”][226 striphtml=1][else]A Systematic Review of Impurity Profiling and Stability Studies in Pharmaceutical Drug Substances[/if 2584]. Research and Reviews: A Journal of Pharmaceutical Science. 04/10/2025; 16(03):-. Available from: https://journals.stmjournals.com/rrjops/article=04/10/2025/view=0

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[if 424 not_equal=””]Regular Issue[else]Published[/if 424] Subscription Review Article

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Volume 16
[if 424 equals=”Regular Issue”]Issue[/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] 03
Received 29/09/2025
Accepted 03/10/2025
Published 04/10/2025
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Publication Time 5 Days

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