Excipient Quality and Impact on Formulation
The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.
The recent discovery of probable carcinogens in widely used APIs triggered a wave of drug recalls, increased regulatory oversight, and new testing procedures. Advanced analysis of excipients may reveal previously unknown ingredients; however, such a discovery prompts the need for better understanding of excipient components, the source and safety profiles of the materials, and the role they play in drug performance.
In this Editors’ Series session, moderated by the editors of Pharmaceutical Technology and BioPharm International, an expert panel discusses the characterization of excipient components, understanding regulatory and compendial implications of excipient composition, the global supply chain, effective quality programs and prospects for preapproval of novel excipients.
The panel, featuring Nigel Langley, global technology director, Pharma Solutions, BASF Corporation; David R. Schoneker, president/owner/consultant, Black Diamond Regulatory Consulting, LLC; and Joseph Zeleznik, technical product manager, IMCD US, was recorded during the 2020 Bio/Pharma Virtual Congress on Nov. 11, 2020.
Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
