Analytical Quality Control News

The official English translation of Supplement II to the Japanese Pharmacopoeia (JP) Eighteenth Edition is now available as a free download.

In Technology Networks, a new article entitled "The Museum of Analytical Antiquities" was published. The authors, Dr. Bob McDowall, a member of the ECA Analytical Quality Control Group Advisory Board, and Paul Smith, explore the risks and challenges laboratories face when they maintain outdated analytical systems and discuss why it is important to keep current with software updates.

In the Pharmacopeial Forum, PF 51(1), a Stimuli article entitled "Characterization of Apex Vessel Geometries and Irregularities" was published. Apex vessels, previously referred to as PEAK vessels, are commonly used in dissolution experiments with Apparatus 2. The study highlights the importance of understanding the geometric variability of apex vessels and its potential impact on dissolution results.

The U.S. Food and Drug Administration (FDA) has published two new documents: a draft guidance referred to as "Considerations for Complying with 21 CFR 211.110" and a final guidance for industry titled "Advanced Manufacturing Technologies Designation Program."