Aegle marmelos (L.) Correa is an Indian medicinal plant known for its vast therapeutic activities. In Ayurveda, the plant is known to balance “vata,” “pitta,” and “kapha” dosh. Recent studies suggest anti-inflammatory, anti-microbial, and anti-diabetic potential but lack in defining the dosage over the therapeutic activities. This study aims to determine the chemical profile of Aegle marmelos fruit extract; identification, enrichment, and characterization of the principal active component(s) having anti-inflammatory and anti-diabetic potential. Targeted enrichment of total coumarins, focusing on marmelosin, marmesin, aegeline, psoralen, scopoletin, and umbelliferone, was done from Aegle marmelos fruit pulp, and characterized using advanced high-throughput techniques. In vitro and in silico anti-diabetic and anti-inflammatory activities were assessed to confirm their efficacy and affinity as anti-diabetic and anti-inflammatory agents. The target compounds were also analysed for toxicity by in silico ADMET study and in vitro MTT assay on THP-1 and A549 cell lines. The coumarins enrichment process designed, was found specific for coumarins isolation as it resulted into 48.61% of total coumarins enrichment, which includes 31.2% marmelosin, 8.9% marmesin, 4% psoralen, 2% scopoletin, 1.7% umbelliferone, and 0.72% aegeline. The quantification with HPTLC and qNMR was found to be correlated with the HPLC assay results. The present study validates the potential use of Aegle marmelos as an anti-inflammatory and anti-diabetic agent. Coumarins enriched from the plant fruit have good therapeutic activity and can be used for Phytopharmaceutical ingredient development. The study is novel, in which coumarins were enriched and characterized by a simple and sophisticated methodology.

The pH of a solution is an important measure of how acidic or alkaline it is. It shows the concentration of hydrogen ions in the solution through a negative logarithm. This measurement gives insight into how a substance behaves chemically. Scientists use a pH electrode to get accurate pH readings, which provides reliable measurements for different tests. pH is a key concept in chemistry and is relevant in many scientific fields, including biochemistry, biology, physics, medicine, agriculture, and environmental science. Keeping the right pH level is crucial in many industries, especially in chemical manufacturing, food production, and environmental protection, as it can directly affect the quality of lab results. Even small changes in pH can lead to major differences in the accuracy of analytical outcomes. This is particularly important when following strict guidelines in pharmacopoeias or conducting research using databases like Scopus and PubMed, where data accuracy is vital. This article explains the essential aspects needed to use pH measurement effectively in analysis. It provides a detailed look at other factors necessary for practical testing. Additionally, it highlights the various ways pH measurements are used, showing their importance across different scientific and industrial areas.

Mpox, formerly known as Monkeypox, has re-emerged as a significant global health concern, marked by its unexpected geographic spread and evolving clinical profile. Initially endemic to Central and West Africa, recent outbreaks have underscored its potential for sustained human-to-human transmission, posing challenges to public health systems worldwide. This paper aims to examine the global epidemiology and impact of Mpox, while also highlighting the responses from regulatory bodies and public health organizations worldwide. Additionally, it seeks to evaluate India's strategic approaches to addressing this issue, identify existing research gaps, and propose future directions to enhance global health preparedness. A comprehensive review of peer-reviewed literature, WHO reports, and national policy documents was conducted to synthesize current knowledge on Mpox transmission, global and regional responses, and regulatory compliance along with shifting geopolitical landscape and India's potential for expanded global health leadership. The global response to Mpox has highlighted disparities in surveillance capacity, regulatory readiness, and access to diagnostics and vaccines. While international mechanisms such as the International Health Regulations (IHR 2005) facilitated coordinated responses, implementation varied across regions. India's response has demonstrated adaptability through surveillance enhancements, diagnostic scale-up, and alignment with WHO guidelines, although challenges remain in areas such as vaccine availability and risk communication. Mpox inspires a call for stronger global health governance and resilient national systems. By addressing research gaps in transmission, vaccine development, and regulations, while embracing a One Health approach and promoting regulatory harmonization and equitable resource distribution, we can pave the way for a future that prevents outbreaks and ensures the health security of our global community.

Detecting N-nitrosamine impurities in medicines has been a significant challenge for drug manufacturers and regulators, especially with the recent emergence of nitrosamine drug substance-related impurities (NDSRIs). The formation of NDSRIs is complex and primarily associated with reactions in the drug product. This paper explores the current technical knowledge on forming these impurities, including the risk factors, reaction conditions, and possible mitigation strategies. While significant scientific progress has been made in these areas, substantial gaps in mechanistic knowledge still make accurate predictions of NDSRI formation very difficult. The pharmaceutical industry's continued work on potential mitigation strategies and the generation of additional scientific data to address these knowledge gaps are crucial. Regulatory guidance and policy will continue to evolve in response to further changes in scientific understanding. In this article, we will delve into the detection methods, the mechanism of action, sample preparation techniques, and regulatory limits for nitrosamine impurities. We also discuss various reported nitrosamine impurities, their chemical structures, and their detection using methods like LC-MS/MS, GC-MS-HS, and HPLC. Additionally, we discuss different sample preparation techniques, such as solid-phase extraction, liquid-liquid extraction, and rapid-fire techniques. This review is intended to provide detailed information to analytical personnel working in various quality control laboratories and research organizations.

Using advanced scientific and risk-based approaches for analytical methods offers significant benefits. Quality by Design (QbD) is a systematic framework that emphasizes understanding and controlling both product and process elements. Adhering to the principles outlined in the ICH guidelines can considerably improve the quality of drug substances, vaccines, immune markers, and medicinal products. This compliance not only enhances product quality but also drives continuous improvement and innovation throughout the entire product lifecycle. Developing and regulating analytical methods are vital for maintaining high standards of product quality. By employing sophisticated scientific techniques and risk-based strategies, stakeholders can use various analytical methods to ensure the consistent production of high-quality active pharmaceutical ingredients (APIs). Techniques such as size exclusion chromatography (SEC), high-performance liquid chromatography (HPLC), gel electrophoresis, Western blotting, SDS-PAGE, and enzyme-linked immunosorbent assays (ELISA) are essential for boosting industrial efficiency and reliability in the pharmaceutical sector. Each technique supports the rigorous testing and validation required for API production, ultimately facilitating the development of safe and effective medical products. Understanding the impact of variability on the performance and results of analytical methods is crucial. The QbD framework adopts a systematic approach that underscores the need to thoroughly understand and effectively manage various aspects of the product and its manufacturing processes—laying the groundwork for ongoing improvements and innovation throughout the product lifecycle. Additionally, strict development and regulation of analytical methods are key to achieving the highest standards of product quality. Fully grasping how variability influences the performance and outcomes of analytical methods is essential, as this understanding optimizes results and maintains consistent quality. Recognizing these dynamics enhances result reliability and supports the goal of delivering safer, more effective healthcare solutions.