About Book
The edited book “Advanced Pharmaceutical Analysis” provides a comprehensive and systematic understanding of modern analytical principles essential for ensuring the safety, efficacy, and quality of pharmaceutical products. It begins with an in-depth exploration of impurity and stability studies, defining impurities and explaining their classifications in active pharmaceutical ingredients and drug substances. The book highlights the advantages and disadvantages of impurity analysis and provides guidelines for quantification according to ICH standards. Detailed sections cover the reporting, listing, qualification, and control of degradation products and residual solvents, supported by analytical methods and regulatory limits. The second chapter focuses on elemental impurities, explaining their classification, control strategies, potential sources, and analytical techniques, including CHNS analysis. It elaborates on stability testing protocols, describing batch selection, container orientation, parameters, sampling frequency, and environmental conditions while emphasizing the mechanistic effects of temperature, pH, and ionic strength on drug stability. The third chapter discusses impurity profiling and degradant characterization, including method development, accelerated stability testing, and shelf-life prediction in accordance with WHO and ICH stability guidelines. It also explains photostability studies and the requirements for biological products. Chapter four shifts focus to phytopharmaceuticals, outlining regulatory needs, analytical protocols, and fingerprinting methods using HPTLC and HPLC, while addressing the challenges of complex herbal matrices. The next two chapters, Biological Tests and Assays I & II, describe the biological principles, assay procedures, and advantages of vaccines and biological products such as tetanus, diphtheria, rabies, oxytocin, heparin, and antivenoms, along with insights into PCR-based gene regulation. The book then transitions to immunoassay techniques, starting with the fundamentals of Immunoassays (IA), antibody production, and quantification methods. Specialized chapters explore Radioimmunoassay, Optical Immunoassay, Enzyme Immunoassay, Fluoroimmunoassay, and Luminescence Immunoassay, each describing their principles, procedures, figures, advantages, and pharmaceutical applications. These chapters demonstrate how immunoanalytical methods enhance sensitivity and specificity in drug quantification. Throughout, the book emphasizes regulatory compliance, method validation, and practical laboratory applications, making it an invaluable resource for pharmacy students, researchers, and professionals seeking advanced analytical knowledge. It bridges theory and practice, integrating modern instrumentation with evolving global standards to prepare readers for real-world analytical challenges.
About Author
Dr Pichika Mallikarjuna Rao is a Professor and Dean of Research at Newcastle University, UK (Malaysia Campus, NuMed). He has 35 years of teaching and Research experience, and his field of expertise is Drug Discovery.
Dr Mak has 10 years of teaching and research experience. She is currently a Senior Lecturer at IMU University, Kuala Lumpur, Malaysia, and was listed as a top 2% researcher in the year 2024. She completed her postdoctoral training at the University of Illinois at Chicago, USA. Her research expertise is in Medicinal Chemistry and Artificial Intelligence in drug discovery to address unmet health needs
Dr. Saheli Pradhan has completed her Ph.D. in Botany under Prof. Arunava Goswami, ISI, Kolkata. She has worked as Post-doctoral Fellow at IIT-Kharagpur, BARC Trombay and CSIR-CIMAP, Lucknow. Her field of expertise is plant science, food technology and nanobiotechnology. She has 18 internationally renowned peer-reviewed publications, 4 book chapters, 1 book and 4 patent to her name having more than 1800 citation altogether. She is also an editor and reviewer of many National and International Journals. Currently she is working as an Assistant Professor at B. K. Birla College, Kalyan.
Dr. Mithlesh Malviya is an Associate Professor of Law with an LL.M. in Mercantile Law and a Ph.D. specializing in POCSO and the Juvenile Justice System. With over nine years of teaching and research experience, she has published numerous research papers, books, book chapters, and holds patents. She is currently serving at the School of Legal Studies & Governance, Career Point University, Kota. Known for her expertise in criminal and child protection laws, she is committed to academic excellence and legal research.
Prof. (Dr.) Manoj Kumar Katual (M.Pharm, MBA, PhD) is a distinguished academician and currently serves as Professor and Principal at Florence College of Pharmacy. With over 18 years of teaching and research experience, he has also held key leadership roles as Dean and Head of Institutions in reputed universities across India. He is the Editor-in-Chief of the African Journal of Health Sciences and has significant expertise in pharmaceutical, biomedical, and healthcare research, particularly in additive formulation and development. Dr. Katual has published more than 125 research articles with over 9,300 citations, achieving an H-index of 42 and i-10 index of 210. He has been recognized among India’s Top 2% Scientists (Pharmaceutical Sciences, 2024) and has authored and edited over 30 books. A recipient of multiple Research Excellence Awards and over 35 national and international honors, he also holds several patents, including five granted inventions.
Dr. Rita Mourya, Principal and Professor at the School of Pharmacy, SAM Global University, Raisen (M.P.), is a respected figure in pharmaceutical education with more than 18 years of academic and research experience. Her distinguished career includes international teaching and research exposure at the University of Gondar, Ethiopia, enhancing her global perspective in pharmaceutical sciences. She has authored 34 research papers, holds 7 patents and 6 design patents, and has contributed 3 book chapters published by Springer along with 2 books for D. Pharm students. She is Recipient of the Distinguished Teacher Award (2024), Best Researcher Award, Young Pharmacy Teacher Award, Young Performer Award (Dubai, 2015) and several other national and international honors, Dr. Mourya is known for her commitment to innovation, academic excellence, and inspiring future pharmacists.
