Katherine Ulman is the owner and Primary for KLU Consulting, LLC.She retired from Dow Corning Corporation after more than 40 years of employment.While at Dow Corning, she held positions as a global regulatory compliance manager for their Healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site.
This article details what co-processed excipients are and how they are made.
This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
Published: April 7th 2026 | Updated: June 12th 2026
August 2nd 2022
Published: April 7th 2026 | Updated: June 12th 2026
September 2nd 2015
