Getting Elemental Impurity Testing Right: Preparing for upcoming regulatory changes with Advanced Analytical Workflows
The Indian pharmaceutical industry is entering a new phase of regulatory alignment as the Indian Pharmacopoeia Commission (IPC) moves toward implementing updated requirements for Elemental Impurities under IP Chapter 5.10, expected in July 2026. Aligned with the ICH Q3D guideline, the revised chapter introduces a comprehensive, risk-based framework to control elemental impurities arising from raw materials, catalysts, excipients, manufacturing processes, and container–closure systems. This transition reflects a broader global shift toward harmonized standards, including USP <232>/<233>, European Pharmacopoeia 5.20, and corresponding requirements across other major pharmacopeias. Together, these frameworks emphasize control based on permitted daily exposure (PDE) limits supported by scientifically sound risk assessments.
As India aligns with these global expectations, pharmaceutical manufacturers must adopt robust analytical and risk management strategies to ensure compliance. This includes implementing sensitive, multi-element detection workflows, where ICP-MS has emerged as the industry benchmark. In this webinar, we will explore how laboratories can prepare for this transition by connecting regulatory expectations with practical analytical execution. The session will cover:
- Risk-based approaches for elemental impurity assessment aligned with ICH Q3D
- Comparative perspectives across IP, USP, EP, and JP frameworks
- Key considerations for analytical method development and multi-element screening
- Practical ICP-MS workflows for reliable and compliant impurity monitoring
Join us to learn how to design analytical strategies that ensure confident compliance with IP Chapter 5.10 while aligning with global standards - strengthening quality, regulatory readiness, and market competitiveness.
Key Learning Outcomes
- Understand upcoming IP 5.10 elemental impurity requirements and global alignment
- Apply risk-based strategies for impurity identification and control
- Select appropriate analytical approaches for multi-element detection
- Implement ICP-MS workflows for reliable, compliant pharmaceutical testing
Presenter: Mr. Arvind Kumar Sharma (Scientific Assistant, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare - Government of India)
With six years of experience as a Scientific Assistant at Indian Pharmacopoeia Commission, he has played a key role in the current development of Indian Pharmacopoeia Reference Substances (IPRS) and Impurity Reference Substances. He has been engaged in the preparation and updating of draft monographs for publishing in Indian Pharmacopoeia (IP). Additionally, he has played a major role in the development of the latest edition of the National Formulary of India 2021 and has been involved in work related to the Pharmacovigilance Programme of India (PvPI). He holds a a M. Pharmacy in Pharmacology from Sinhgad Institute of Pharmaceutical Sciences, Pune and a B. Pharmacy from the College of Pharmacy, IPS Academy Indore. He has authored several articles published in international journals and organized and represented IPC at various national and international conferences and workshops. He has also participated in joint inspections for registration of manufacturing units and testing laboratories.
Presenter: Dr. Vinay Jain (Application Engineer, Agilent Technologies, India)
Dr. Vinay Jain is working as the CoE Manager and Country Food Workflow Commercialization Lead at Agilent Technologies International. He holds a Ph.D. in Analytical Chemistry and has more than 33 years of analytical and research experience in spectroscopic and mass spectrometry techniques.
His specialization includes the development and validation of new analytical methods in accordance with regulatory guidelines. He has completed over 28 research projects with various national and international research and regulatory organizations. He holds two patents, has published 59 research papers, contributed two chapters to international handbooks, and authored 15 Agilent application notes. He received the Agilent TechInnovation Award in 2020 and 2022 for providing end-to-end workflow solutions. One of his innovations on LC-ICPMS was selected for the Winter Plasma Conference, and two were selected for the European Winter Plasma Conference for poster presentations.
Presenter: Dr. Kuldeep Sharma (Business Development Manager - Pharma, Agilent Technologies)
Dr. Kuldeep Sharma has over 23 years of experience in area of pharmaceuticals analytical R&D, analytical method development and validation, clinical and preclinical studies, and regulatory compliance. His professional journey covers a true blend of technical and commercial industry insight, with a PhD in biotechnology, over 13 years as an analytical research scientist (with leading pharma companies like Zydus Cadila, Lambda, Teva, and Jubilant Biosys), and 10 years as techno-commercial expert leading analytical instruments sales strategies and marketing initiatives.
During his industry experience, he has accomplished leading roles in domains covering analytical research, pharma quality compliance, and preclinical and analytical studies. With over 21 research articles published in international journals and 5 technical write-ups in leading magazines, he presents an attitude of continued learning, enabling him to acquire advance certifications of Lean Six Sigma-Black Belt and MBA (Operations Management) in addition to his professional journey.
Presently, he works as a sales development manager for pharmaceutical markets at Agilent Technologies in India.
