USP <232>/ <233> and ICH Q3D | Prepare Your Lab to Measure and Mitigate Elemental Impurities in Drug Products

This webinar discusses about total solution approach for USP Chapters <232>/ <233> and ICHQ3D.

We will clarify regulatory requirements and recommended analytical methods for elemental impurities analysis in Pharmaceuticals.

Join us to learn about total workflow of microwave digestion for sample preparation and instrumental analysis using ICPMS following total regulatory compliance for data management. Also learn about how to overcome the challenges posed by ICHQ3D guideline, by removing metals from APIs or intermediates using metal scavengers.

Learning Objectives:

• Elemental Impurities Regulations: USP Chapters <232>/ <233>, ICH Q3D

• Elemental Analysis Workflow using ICPMS in compliance with USP <232> and <233>

• Implementing Microwave Digestion technology for Sample preparation

• Mitigating the common Metal Impurities in Pharmaceutical Products using Metal Scavengers

Presenter: Dr. Pravin Konde (Product Specialist (Atomic Spectroscopy), Shimadzu Asia Pacific)

Dr. Pravin is a Product Specialist (Atomic Spectroscopy) at Shimadzu Asia Pacific and has been based at Singapore. He has more than 12 years of industry experience of which about 10 years in analytical instruments with expertise in trace element analysis applications using AAS, ICP-OES & ICP-MS. He is engaged primarily in technical support to regional sales teams and customers. Prior to joining industry, he has done his PhD in Chemistry from Institute of Chemical Technology (formerly UDCT), Mumbai, India.

Presenter: Yogesh Baldua (Dy. General Manager (Elemental & Spectroscopy), Toshvin Analytical Pvt. Ltd.)

Yogesh is Deputy General Manager at Toshvin Analytical, India. He has overall 20 years of working experience in analytical instruments industry and has worked with many leading Multinational and Indian organizations. In his current role at Toshvin, he provides product and technical support to the sales team on Shimadzu elemental analysis products like AAS, ICPE, ICPMS and PreeKem Scientific for wide range of microwave digestion systems.

Presenter: Sunil Rana (Global Business Manager for Biotage Scale-Up business, Biotage AB, Sweden)

Dr. Sunil gained his BSc. Double Honours degrees in Chemistry and Biochemistry from the University of Southampton, UK in 1997 and completed an organic polymer/peptide chemistry PhD. with Professor Mark Bradley. During an Industrial post-doc at Argonaut Technologies, USA, he developed novel supported reagents/scavengers, then headed the analytical and chemical production groups. In 2008, he moved from Senior Scientist/Project Manager to Global product management. Sunil has an MBA from the Open University (UK), is a member of the ACS (21+yrs) and been involved in numerous publications and patent applications. He is Global Business Manager for Biotage Scale-Up business.