The Global Chemical Industries Summit: From Raw Material Identification to Fine and Specialty Chemicals Analysis for Hydrocarbons, Agrochemicals, and Pharmaceuticals (Day 2)

Register Free: https://www.chromatographyonline.com/lcgc_w/global_chemical

Day 2: Pharmaceuticals

Summary:

PerkinElmer is pleased to provide a platform for the Pharma Chemical community to share their experience and work. This fully virtual event will discuss current topics and analytical challenges facing the Pharma Chemical market and community. Participants and speakers will include industry professionals and global leaders, as well as academic and governmental scientists.

Key Learning Objectives:

• Discover the use of NIR applications for API/excipient characterization and content uniformity of tablets
• Learn about our solution approach to USP testing
• Be able to have a solution to identify raw materials
  

Morning

10:00am EDT – 10:30am EDT
Raw Materials ID
Chris Borgia, Senior Technical Associate, Colgate Palmolive

At Colgate the quality and safety of our products is our number 1 concern. As part of ensuring this, we employ a comprehensive raw materials testing process utilizing principally FTIR. In this talk I intend to give you an overview of this process and we use AssureID software to carry out and continuously optimize the testing.

10:30am EDT – 11:30am EDT
Strategies for Elemental Impurities Testing in Pharmaceuticals
Aaron Hineman, Inorganic Product Line Leader, Americas, PerkinElmer

With regulatory requirements, validation protocol, and data integrity all being in the forefront, it is important to equip the laboratory with more than just analytical equipment. By providing tools, resources and knowledge, PerkinElmer’s total solution approach to USP testing enables laboratories to be analyzing samples faster and ensures compliance with regulations on electronic records and signatures. In this talk, we will discuss:

• USP Chapters 232 and 233 and ICH Q3D
• 21 CFR Part 11 requirements and compliance
• PerkinElmer’s offerings to streamline your elemental impurity testing
• Syngistix software to ensure data integrity and compliance

Speakers:

Chris Borgia

Senior Technical Associate

Colgate Palmolive

Aaron Hineman

Inorganic Product Line Leader, Americas

PerkinElmer

Afternoon

1:00pm EDT – 1:30pm EDT

Detection of Genotoxic impurities in API during pharmaceutical development
Dr Nagarjuna P Reddy, Managing Director, Revin Labs Private Limited

Talk will capture various source of these genotoxic impurities and techniques to characterize and identify these impurities. NDMA, a pharmaceutical Class 1 impurity, has been identified as a probable human carcinogen. It’s also a known environmental contaminant that is found in water and foods, including meats, dairy products and vegetables. The source of nitrosamine impurities in active pharmaceutical ingredients (API) is varied, and the impurity can be introduced under a variety of stages in the API manufacturing process. Hence its essential to identify these impurities and limit them below the various regulatory guidelines in the finished drug products.

1:30pm EDT – 2:00pm EDT
Near-Infrared Tablet Content Uniformity and Excipient Characterization
Dr. Prakash Muthudoss, Senior Manager, Formulation Analytical, Oncogen Pharma

This talk will start with a brief introduction, and then discuss two pivotal examples of NIR applications using statistical machine learning in the pharma industries: (a) API/excipient characterization and (b) content uniformity of tablets. The pharmaceutical industry must ensure correct dosing and manufacturing of stable products. This entails strictly controlling the raw materials and each of the steps involved in their processing by determining parameters such as potency, moisture, density, viscosity, and particle size to identify and correct any deviations in the manufacturing process in a timely fashion. Such controls can be achieved by quantifying the different parameters of API and excipients required using appropriate analytical methods such as NIR. This is achieved by comparing the NIR spectrum of the sample with a body of spectra of the samples meeting the required specifications and encompassing all possible sources of manufacturing variability. Similarly, ensuring homogeneous mixing of the components (APIs and excipients) of a pharmaceutical preparation is a crucial prerequisite for obtaining proper solid dosages (tablets and capsules). Currently, such requirements are satisfied using HPLC. However, the HPLC technique is tedious, time-consuming, and destructive. This procedure also involves use of caustic and/or hazardous solvents. NIR spectroscopy enables the analysis of complex matrices without the need to manipulate samples. This results in substantially decreased analysis time relative to wet chemical methods. Similarly, it provides accurate means of characterizing tablet that are in step with FDA's process analytical technology (PAT) initiative.

2:00pm EDT – 2:30pm EDT
Residual Solvents Analysis (USP 467)
Dr. Vijayavitthal T. Mathad, M. Sc, Ph. D, Sr. VP, MSN Laboratories

We will discuss discovering (screening) novel polymorphic forms for handling the metastable polymorphs for the entire gametes of API’s across MSN Pharma and trouble-shooting of the problems associated with solid state characteristics/ polymorphic issue of the API’s at plant scale.

2:30pm EDT – 3:00pm EDT
Informatics Tools for Accelerating Drug Discovery in Pharma R&D
Dr. Kamlesh Padiya, Associate Director, Process Research and Development, NDDD, Lupin

Lupin Pharmaceuticals uses Informatics to expedite its data analysis and ultimately its drug discovery research projects. Lupin generates significant amounts of data on each of its research projects and the management, tracking and the expeditious analysis of these data through informatics is an important tool in our arsenal.

Speakers:

Dr. Nagarjuna P Reddy

Managing Director

Revin Labs Private Limited

Dr. Prakash Muthudoss

Senior Manager, Formulation Analytical

Oncogen Pharma

Dr. Vijayavitthal T. Mathad, M. Sc, Ph. D

Sr. VP

MSN Laboratories

Dr. Kamlesh Padiya

Associate Director, Process Research and Development, NDDD

Lupin Pharmaceuticals

Sponsor

PerkinElmer

Register Free: https://www.chromatographyonline.com/lcgc_w/global_chemical