Dr. Nagaraju Rajana was born in Vizianagaram district of Andhra
Pradesh. He obtained his Master of Science degree with a specialization in Analytical Chemistry from Andhra University, where he also completed his Ph.D. in an extramural full‐time program in collaboration with Dr. Reddy’s Laboratories and Andhra University during 2017–2019. His Ph.D. research was conducted under the guidance of Dr. J. Moses Babu, an expert in Mass
Spectrometry and NMR, and Prof. (Dr.) K. Basavaiah, an expert in Analytical Chemistry and Nanomaterials. Currently, Dr. Nagaraju Rajana is working as a Scientist at the CSIR‐Indian Institute of Chemical Technology (IICT). Dr. Nagaraju Rajana has over 13 years of experience in the Department of Analytical Research and Development as an Analytical Scientist/Subject Matter Expert in various pharmaceutical companies, including Dr. Reddy’s Laboratories Ltd., Aurigene Pharmaceutical Services Ltd.,
and Sai Life Sciences Ltd. He has published more than 35 papers in national and international journals.
Dr. Rajana has extensive hands‐on experience with hyphenated
techniques such as LC‐MS/MS, GC‐MS/MS, ICP‐MS, and ICP‐OES, as well as chromatographic techniques like HPLC, GC, and ion chromatography. He is an expert in impurity profiling of drug substances and drug products using LCMS/MS and GC‐MS, and in structural elucidation of raw materials, intermediates, and APIs using techniques such as Mass Spectrometry, NMR, UV, SOR, XRD, DSC, and TGA.
He also specializes in the assessment and risk analysis of potential genotoxic impurities, including general nitrosamine impurities and NDSRIs in drug substances and products. His work involves the development, validation,and quantification of PGIs using LC‐MS/MS and GC‐MS/MS. Additionally, Dr.Rajana has significant experience in analytical method development, methodvalidation, and method transfer during the commercialization of APIs.
Dr. Rajana has worked in cGMP‐compliant facilities and
participated in global regulatory audits such as FDA, PMDA, and EMA. He has experience handling incidents, out‐of‐trend (OOT) and out‐of‐specification (OOS) results, and conducting investigations using advanced root cause analysis tools.
He has also managed digital analytical software systems like LIMS,
ELN, ACD, and MestReNova in Quality Control and Analytical Research and
Development departments. Furthermore, he holds a Six Sigma Yellow Belt
certification from Dr. Reddy’s Laboratories for the period of 2024–2025.
Dr. Rajana’s current research focuses on the identification,
characterization, method development, and validation of PGIs (genotoxic impurities/N‐nitrosamine impurities/NDSRIs) in therapeutic drugs using LCMS and GC‐MS. He is also involved in impurity profiling of drug substances and products using LC‐MS, GC‐MS, NMR, chromatography, and spectroscopic techniques.