Anand Prakash,
- Student, Department of Pharmaceutical Chemistry, S.N. College of Pharmacy, Jaunpur, Uttar Pradesh, India
Abstract
Ensuring 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.
Keywords: Stability studies, impurity profiling, ICH guidelines, forced degradation, HPLC, LC-MS, drug degradation, shelf life, and pharmaceutical analysis
[This article belongs to Research and Reviews: A Journal of Pharmaceutical Science ]
Anand Prakash. A Systematic Review of Impurity Profiling and Stability Studies in Pharmaceutical Drug Substances. Research and Reviews: A Journal of Pharmaceutical Science. 2025; 16(03):81-88.
Anand Prakash. A Systematic Review of Impurity Profiling and Stability Studies in Pharmaceutical Drug Substances. Research and Reviews: A Journal of Pharmaceutical Science. 2025; 16(03):81-88. Available from: https://journals.stmjournals.com/rrjops/article=2025/view=228643
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Research and Reviews: A Journal of Pharmaceutical Science
| Volume | 16 |
| Issue | 03 |
| Received | 29/09/2025 |
| Accepted | 03/10/2025 |
| Published | 04/10/2025 |
| Publication Time | 5 Days |
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