Harmonized USP Chapter 621 Chromatography – Recent Revisions

USP General Chapter <621> Chromatography is one of the most significant general chapters of USP-NF compendia, referenced in several components such as identity, assay, impurities and foreign substances, etc., of almost all its monographs.

Establishing meaningful system suitability criteria for chromatography procedures are the key in obtaining reportable results used for compendial/regulatory compliance purpose. The chapter provides definitions for chromatographic attributes and parameters and the extent of adjustments in chromatographic conditions that can be done to the compendial procedures provided the system suitability criteria set and other performance characteristics are met.

In this webinar we will give an overview of General Chapter <621> Chromatography and the allowed adjustments to chromatographic conditions in the USP monographs based on the recent revisions of General Chapter <621>. Some case studies will be discussed.

Presenter: Manu Grover (Business Development Manager – Pharma Markets, Agilent Technologies, Inc.)

Manu Grover holds a postgraduate degree in Pharmacy from Manipal Academy, India. He has more than 21 years of chromatography experience and has worked in pharmaceuticals to support IND, NDA, and ANDA filings incompanies such as Dr. Reddy's, Panacea Biotec, and Ozone Pharmaceuticals. During his professional journey, he has developed and validated analytical methods on HPLC, GC, particle sizing, DSC, pXRD, and LC/MS instruments, as well as successfully filing multiple analytical dossiers in U.S./EU markets. In his current role, he works closely with the Agilent sales team, regulators, and pharmaceutical scientists. He shares market updates, trends, and expertise related tothe Agilent portfolio of columns and supplies.

Presenter: Edmond Biba, Phd (Principal Scientist, USP)

Dr. Edmond Biba is a Principal Scientist in the General Chapters Department, Science Division, at the United States Pharmacopeial (USP) Convention. He is responsible for the development of several new USP-NF General Chapters, including a suite of chapters on Analytical Methodologies Based on Scattering Phenomena, Nitrosamine Impurities, and Image Analysis of Pharmaceutical Systems. These were produced with the USP volunteers and expert committee/expert panel members.

One of his responsibilities is maintaining a portfolio of USP-NF General Chapters. This includes keeping up-to-date scientific and regulatory content in these chapters by continuously reviewing and revising the chapters as needed, with the help of responsible USP expert committees or expert panels. Some representatives of the current chapters in the portfolio are: <621> Chromatography, <197> Spectroscopic Identification Tests, <467> Residual Solvents, <1469> Nitrosamine Impurities, <429> Light Diffraction Measurements of Particle Size, <430> Particle Size Analysis by Dynamic Light Scattering, <432> Determination of Zeta Potential by Electrophoretic Light Scattering, <854> Mid-Infrared Spectroscopy.

Dr. Biba received his Ph.D. in Synthetic Organic Chemistry from the American University, Washington DC, and a B.Sc. and M.Sc. in Chemical Engineering and Chemistry from the University of Tirana, Albania. Dr. Biba is member of Sigma Xi, the Scientific Research Honor Society, the American Chemical Society, and the American Association of Pharmaceutical Scientists. He is USP’s representative for ICH’s Residual Solvents Q3C (R9) and Mutagenic Impurities M7 (R2) working groups, and to the Product Quality Technical Committee (PQTC) of the Product Quality Research Institute (PQRI).