Reference standards in pharmaceutical analysis MasterClass - US edition

Reference standards are often an integral part of analytical procedures in pharmaceutical analysis and Quality Control, and their integrity is key for the accuracy of results.

18-19 March, 2026, Virtual

Time Zone: Eastern Daylight Time (EDT) - UTC04:00

Overview

Reference standards are often an integral part of analytical procedures in pharmaceutical analysis and Quality Control, and their integrity is key for the accuracy of results. They are often used for a long time, so any issue will have a tremendous impact, as many released batches could be affected. Therefore, a thorough characterisation, in particularly the appropriate assignment of a content (if relevant), a thorough documentation, an appropriate storage and stability assessment is essential. Aligned with this crucial importance, compendia provide official reference standards within the scope of their monographs and general chapters, but also have established comprehensive information and requirements with respect to their characterisation, maintenance, and application. This can well be used as orientation for in-house reference standards, in order to prepare for regulatory submissions, as well as for inspections and audits.

Also, the draft of the new ICH guidance Stability Testing of Drug Substances and Drug Products includes a new chapter on reference materials. Participants will receive practical orientation and recommendations concerning appropriate characterisation, content assignment, use and maintenance (stability requirements) depending on the type of reference standard.

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WHO SHOULD ATTEND

-Analysts and managers in Quality Control and pharmaceutical analytics
-Quality Assurance
-Regulatory affairs
-Audit responsible