ICH guidelines
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A Systematic Review of Impurity Profiling and Stability Studies in Pharmaceutical Drug Substances
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 …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 3, 2025 · pp. 81–88 Read article
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RP-HPLC Analytical Method Development and Validation for Quantitative Estimation of Metoclopramide Hydrochloride in Solid Oral Formulations
Abstract: RP-HPLC technique formulated for the numerical assessment of Metoclopramide Hydrochloride in tablet formulation has been confirmed for reliability. A C18 column facilitated the chromatographic separation using a mobile phase comprising 60:40 (v/v) potassium dihydrogen phosphate buffer: meth anol mixture. Such method was used to detect, where the retained time was 6.78 minutes and Metoclo pramide Hydrochloride produced a clear peaked at 273 nm. Results were in agreement with ICH Q2 …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 2, 2025 · pp. 07–15 Read article