Introduction
In this Virtual Chemicals Testing Summit, the series of webinars and resources are focused on overcoming analytical quality and testing challenges in the pharmaceutical and personal care products (PCP) arena. Presentations are shared from world-class PCP manufacturers like Colgate-Palmolive Company, pharmaceutical companies including Oncogen, MSN Group and Lupin Limited, contract labs including Revin Labs, and from inorganic analytical experts from PerkinElmer, to present their methods and applications for raw materials analysis and quality checks along the manufacturing process to meet regulatory requirements like FDA 21 CFR Part 11 compliance, USP compliance and other regulatory directives.
Here, we have collected the webinar presentations for your convenience; click any of the topics to watch the webinars.
Pharmaceutical Chemicals Webinar Hub
Raw Materials ID, Colgate-Palmolive Company
In this presentation, Chris Borgia, Senior Technical Associate at Colgate Palmolive overviews how they build methods with PerkinElmer AssureID software for the analyses and optimization of testing, for their quality standards, FDA 21 CFR Part 11 compliance, their green technology, and the business impact of working with PerkinElmer.
Strategies for Elemental Impurities Testing in Pharmaceuticals
In this presentation, Aaron Hineman, Inorganic Product Line leader discusses the tools, resources and knowledge that a total solution approach offers to USP testing to enable laboratories to analyze samples faster and ensure compliance with regulations on electronic records and signatures.
Thermal Analysis as a Characterization tool in the Pharmaceutical Industry, MSN Laboratories
In this presentation by Dr. Vijayavitthal T. Mathad, Sr. Vice President of R&D at MSN Laboratories reviews Thermal Analysis techniques such as TGA and DSC, two important tools for understanding the physiochemical properties of active pharmaceutical ingredients (APIs) in pharmaceuticals. Several TGA and DSC applications and case studies collected from Dr. Mathad’s lab are discussed.
Residual Solvents Analysis: USP 467, MSN Laboratories
In this presentation by Dr. Vijayavitthal T. Mathad, Sr. Vice President of R&D at MSN Laboratories reviews residual solvents analysis for USP 467 compliance, its regulatory directives and challenges. Topics include quality attributes of drug substance APIs, risk assessments, and testing procedures for residual solvent impurities, analytical techniques involved, and the challenges and business impacts of non-compliance.
Detection of Genotoxic Impurities in API During Pharmaceutical Development, Revin Labs Private Limited
Dr. Nagarjuna P Reddy, Managing Director of Revin Labs reviews the sources of genotoxic impurities (GTI) and techniques to identify and characterize them. This presentation reviews NDMA, an N-nitrosamine pharmaceutical Class 1 impurities, their regulatory guidelines and hazard assessment approaches utilizing LC/MS/MS for low detection if NDMA.
Near-Infrared (NIR) Tablet Content Uniformity and Excipient Characterization, Oncogen Pharma
Dr. Prakash Muthudoss, Sr. Manager, Formulation Analytical at Oncogen Pharma discusses NIR applications using statistical machine learning in the pharmaceutical industry, including API/excipient characterization, content uniformity, and moisture analysis of tablets, along with methods for the identification and correction for deviations using NIR.
Informatics Tools for Accelerating Drug Discovery in Pharmaceutical R&D, Lupin Limited
Dr. Kamlesh Padiya, Associate Director, Process Research and Development at Lupin, presents “Data to Drug” and their “Synformatic System”, an approach utilizing synchronized informatics systems to expedite data analysis and ultimately its drug discovery research projects. Tracking and expeditious analysis of Lupin’s significant data quantity via informatics, is important to building a promising future.