Regulatory Pharma Blogs
Q4B Annex 14 Bacterial Endotoxins Test: General Chapter 1. Introduction: Bacterial Endotoxins Test Bacterial Endotoxins Test: This annex is the outcome of the Q4B process, which pertains to the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG), which is a global body composed of the major pharmacopoeias …
Q4B ANNEX 13 Bulk Density and Tapped Density of Powders: A Comprehensive Overview 1. Introduction: Bulk Density and Tapped Density Bulk Density and Tapped Density: The Bulk Density and Tapped Density of powders are essential parameters in various industries, particularly in pharmaceuticals. They provide critical information about the flow properties, packing behavior, and compactibility of …
Q4B Annex 12 Analytical Sieving General Chapter 1. Introduction: Analytical Sieving Analytical Sieving: The document at hand represents the outcome of the Q4B process regarding the Analytical Sieving General Chapter. The proposed texts, which are the result of deliberations and discussions within the Pharmacopoeial Discussion Group (PDG), aim to harmonize the approach to analytical sieving …